FDA Reauthorization Act of 2017 (FDARA)

Size: px
Start display at page:

Download "FDA Reauthorization Act of 2017 (FDARA)"

Transcription

1 FDA Reauthorization Act of 2017 (FDARA) April 4, 2018 PRESENTED BY: Jessica Ringel Counsel FDA & Life Sciences Practice Group King & Spalding LLP (202)

2 FDA Reauthorization Act of 2017 Effective August 18, 2017 Contains user fee reauthorizations PDUFA MDUFA GDUFA BsUFA Also contains provisions regarding drug development and access, generic drug access 2

3 MDUFA IV

4 MDUFA IV (FDARA ) Significant fee increases, to meet increasing statutory revenue amounts: FY 2017 actual to FY 2018 actual Establishment registration: 37% increase PMAs and PMA supplements: 33% increase 510(k): 125% increase New user fee for de novo submissions 30% of the PMA base fee Small businesses get a break on 510(k) fee increases Increase of 12.6% from FY 2017 to FY 2018 But increase of 33% on PMA-related user fees No reduction of establishment registration fees New statutory requirement to apply an inflation adjustment to the user fee every year, including FY

5 User Fees, FY MDUFA III MDUFA IV (FDARA) Fee Type FY 2017 FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Establishment registration $3,382 $4,624 $4,548* $4,760* $4,975* $4,978* PMA/BLA $234,495 $310,764 $300,000* $310,000* $328,000* $329,000* 510(k) $4,690 $10, % 3.4% 3.4% 3.4% De Novo classification n/a $310,764 30% 30% 30% 30% Panel-track supplement $175,871 $233,073 75% 75% 75% 75% 180-day supplement $35,174 $46,615 15% 15% 15% 15% Real-time supplement $16,415 $21,753 7% 7% 7% 7% BLA efficacy supplement $234,495 $310, % 100% 100% 100% PMA annual report $8,207 $10, % 3.5% 3.5% 3.5% 30-day notice $3,752 $4, % 1.6% 1.6% 1.6% Adjusted for inflation * Subject to adjustments for inflation and to meet statutory revenue goals Note: Small business fees are 25% of the listed amounts, except for the 30-day notice (50%) and establishment registration (no reduction) fees 5

6 Device Provisions in FDARA

7 Inspections: Risk-Based Schedule (FDARA 701) Requires FDA to conduct establishment inspections on a risk-based schedule, using the following factors: Compliance history History of recalls Inherent risk of the device Inspection frequency and history Whether there were any FDA inspections in the previous 4 years Foreign government inspections Participation in international device audit programs (e.g., MDSAP) Replaces statutory requirement to inspect Class II and III device establishments every 2 years 7

8 Inspections: Uniform Processes and Standards (FDARA 702) Requires FDA to establish uniform processes and standards for routine (not for cause) device inspections, to include: Exceptions to processes and standards Pre-announcement of routine inspections Within a reasonable time in advance Notification regarding the type and nature of the inspection Estimate of the inspection timeframe Opportunity for advance communication regarding working hours and records to be requested Regular communication during the inspection regarding the inspection status Draft guidance required by February 18,

9 Inspections: Feedback (FDARA 702) New statutory requirement for FDA to provide feedback on a firm s 483 corrective actions, upon request Feedback required if: Request is timely Corrective actions relate to: Public health priority Systemic or major actions, or Emerging safety issue Response within 45 days after receipt of a request Feedback is nonbinding 9

10 Inspections: Draft Guidance (FDARA 702) Draft guidance required by February 18, 2019 Device inspection processes and standards for routine inspections Feedback on corrective actions Standard methods for communication regarding inspections and feedback Standard timeframes for foreign and domestic device inspections Occurring over consecutive days Extensions upon investigator s identification of a reason to the establishment Practices to facilitate the continuity of inspections 10

11 Inspections: Refusals (FDARA 702) Devices are now deemed adulterated if an establishment delays, denies, limits, or refuses an inspection FDA Guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (Oct. 2014) Delay Postpones the start of an inspection without reasonable explanation Leaves the investigator without access to requested documents or personnel for unreasonable time Limiting Discontinues manufacturing during inspection or limits direct observation without reasonable explanation Prohibits photography without reasonable explanation Unreasonably redacts requested documents 11

12 Inspections: Pathway to CFG Issuance (FDARA 704) FDA must provide a written explanation of the basis for a CFG denial Identify the finding upon which the denial is based For denials based on QSR non-compliance, include a substantive summary of the specific grounds for noncompliance Unless basis is injunction, seizure, Class I or II recall Prohibits CFG denials based solely on 483 observations if the firm has agreed to a plan of correction Requires process for a review of CFG denials Firms can request a review and submit new information, including evidence of corrective actions to address the identified noncompliance Requires draft guidance by August 18,

13 Inspections: International Recognition (FDARA 705) Adds statutory permission for FDA to recognize auditors used by organizations established by foreign governments Improve international harmonization of inspection standards Increase FDA access to audit data FDA retains ability to classify inspections Related: FDARA 703 reauthorizes FDA s ability to conduct inspections via accredited organizations through

14 Pediatric Devices (FDARA 502) Extends for five years the ability to sell pediatric Humanitarian Use Devices for more than the development and production cost of the device Until October 1, 2022 (unless extended again before then) Requires FDA to hold a public meeting to discuss the development, approval, or clearance and labeling of pediatric medical devices Scheduled for August 13-14, 2018 Registration open until August 6 Meeting will be webcast More details here: Conferences/ucm htm 14

15 Medical Device Accessories: Alternative Pathway to Market (FDARA 707) Pathway for classification and reclassification of accessories based on the accessory s risk, not the parent device Initial classification: may request separate classification of parent device and accessories in 510(k) or PMA submission Reclassification: may request reclassification of accessories already approved or cleared under a parent device s PMA or 510(k) FDA must provide opportunity to meet before submission of written request FDA must respond to the request within 85 calendar days If FDA denies the request, must include a detailed justification Must publish granted reclassifications in the Federal Register within 30 calendar days htm Every 5 years, FDA must publish a proposed list of Class I accessory types 15

16 Other FDARA Device Provisions 510(k) clearance or PMA approval for medical imaging devices when intended for use with a contrast agent in a manner different from that in the contrast agent s labeling (FDARA 706) Pilot projects to improve postmarket surveillance (FDARA 708) Establishment of a new category of over-the-counter hearing aids (FDARA 709) Report on FDA regulation of servicing devices (FDARA 710) 16

17 FDA Actions Required by FDARA Guidance Topic Deadline FDA Action? Report on FDA website re: servicing of devices May 15, 2018 Not yet Meeting on pediatric device development Aug. 18, 2018 Draft guidance on CFGs, explanation of denials and review process Draft guidance on inspection process, timeframes, and feedback Report to Congress on postmarket surveillance pilot projects Final guidance on regulatory requirements for hearing aids and personal sound amplification products Report to Congress on OTC hearing aid adverse events Third party review of the postmarket surveillance pilot projects Aug. 18, 2018 Feb. 18, 2019 Feb. 18, 2019 Date that final OTC hearing aid regs are issued 2 years after final OTC hearing aid regs Jan. 31, 2021 Scheduled for Aug , 2018 On CDRH FY 2018 guidance development A list Not on CDRH FY 2018 guidance development list Not yet Not on CDRH FY 2018 guidance development list n/a n/a 17

18 Questions?

MDUFA Performance Goals and Procedures Process Improvements Pre-Submissions Submission Acceptance Criteria Interactive Review

MDUFA Performance Goals and Procedures Process Improvements Pre-Submissions Submission Acceptance Criteria Interactive Review Page 1 MDUFA Performance Goals and Procedures... 3 I. Process Improvements... 3 A. Pre-Submissions... 3 B. Submission Acceptance Criteria... 4 C. Interactive Review... 5 D. Guidance Document Development...

More information

Received an RTA Deficiency List or AI Letter? Now What?

Received an RTA Deficiency List or AI Letter? Now What? Received an RTA Deficiency List or AI Letter? Now What? Dealing with Unexpected Issues/Questions during the Submission Review Process Navigating Submission Challenges to reduce time & risk September 26,

More information

The FDA Medical Device User Fee Program: MDUFA IV Reauthorization

The FDA Medical Device User Fee Program: MDUFA IV Reauthorization The FDA Medical Device User Fee Program: MDUFA IV Reauthorization Judith A. Johnson Specialist in Biomedical Policy June 6, 2016 Congressional Research Service 7-5700 www.crs.gov R44517 Summary The Food

More information

The FDA Medical Device User Fee Program

The FDA Medical Device User Fee Program Judith A. Johnson Specialist in Biomedical Policy June 25, 2012 CRS Report for Congress Prepared for Members and Committees of Congress Congressional Research Service 7-5700 www.crs.gov R42508 Summary

More information

GAO MEDICAL DEVICES. Status of FDA s Program for Inspections by Accredited Organizations. Report to Congressional Committees

GAO MEDICAL DEVICES. Status of FDA s Program for Inspections by Accredited Organizations. Report to Congressional Committees GAO United States Government Accountability Office Report to Congressional Committees January 2007 MEDICAL DEVICES Status of FDA s Program for Inspections by Accredited Organizations GAO-07-157 Accountability

More information

Postmarketing Drug Safety and Inspection Readiness

Postmarketing Drug Safety and Inspection Readiness Postmarketing Drug Safety and Inspection Readiness June 19, 2018 Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) Webinar United States Food and Drug Administration

More information

DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: August 5, 2008

DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: August 5, 2008 Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff Humanitarian Device Exemption (HDE) Regulation: Questions and Answers DRAFT GUIDANCE This guidance

More information

Document issued on: July 8, 2010

Document issued on: July 8, 2010 Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff Humanitarian Device Exemption (HDE) Regulation: Questions and Answers Document

More information

Center for Drug Evaluation and Research - Compliance Central with FDA Center Compliance Directors: Part 1

Center for Drug Evaluation and Research - Compliance Central with FDA Center Compliance Directors: Part 1 Center for Drug Evaluation and Research - Compliance Central with FDA Center Compliance Directors: Part 1 Donald D. Ashley, JD 2017 FDLI Enforcement, Litigation, and Compliance Conference: For the Drug,

More information

Complaint Handling and Medical Device Reporting (MDRs)

Complaint Handling and Medical Device Reporting (MDRs) Complaint Handling and Medical Device Reporting (MDRs) FDA Small Business Regulatory Education for Industry (REdI) Bethesda, MD September 26, 2013 Andrew Xiao Consumer Safety Officer, Postmarket and Consumer

More information

Pre-Submissions and Meetings with FDA Staff

Pre-Submissions and Meetings with FDA Staff Pre-Submissions and Meetings with FDA Staff Soma Kalb, PhD Acting Director, IDE Program Office of Device Evaluation Elizabeth Hillebrenner, MSE Policy Analyst Office of In Vitro Diagnostics & Radiological

More information

FDA Perspective on the Pre- Submission Program: Updates from MDUFA IV

FDA Perspective on the Pre- Submission Program: Updates from MDUFA IV FDA Perspective on the Pre- Submission Program: Updates from MDUFA IV Maureen Dreher, PhD Policy Analyst Clinical Trials Program/ Office of Device Evaluation/ CDRH Agenda Pre-Submission Program background

More information

Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements

Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements Guidance for Industry and FDA Staff Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements Document Issued on: February 28, 2008

More information

GDUFA II: Requests for Reconsideration

GDUFA II: Requests for Reconsideration GDUFA II: Requests for Reconsideration Priya Shah, Pharm.D. Immediate Office Project Manager Office of Regulatory Operations, Office of Generic Drugs Purpose To provide an overview of requests for reconsideration

More information

Establishment Registration and Device Listing. Michelle C. Jackson, Esq. Partner Venable LLP

Establishment Registration and Device Listing. Michelle C. Jackson, Esq. Partner Venable LLP Establishment Registration and Device Listing Michelle C. Jackson, Esq. Partner Venable LLP Learning Objectives Statutory Basis for Registration and Listing Relevant Regulations Who Must Register and List

More information

WikiLeaks Document Release

WikiLeaks Document Release WikiLeaks Document Release February 2, 2009 Congressional Research Service Report RL34571 Medical Device User Fees and User Fee Acts Erin D. Williams, Domestic Social Policy Division July 14, 2008 Abstract.

More information

PLAN OF ACTION FOR IMPLEMENTATION OF 510(K) AND SCIENCE RECOMMENDATIONS

PLAN OF ACTION FOR IMPLEMENTATION OF 510(K) AND SCIENCE RECOMMENDATIONS PLAN OF ACTION FOR IMPLEMENTATION OF 510(K) AND SCIENCE RECOMMENDATIONS In August 2010, the Food and Drug Administration s Center for Devices and Radiological Health (CDRH or the Center) released for public

More information

Texas Department of State Health Services

Texas Department of State Health Services Texas Department of State Health Services DRUGS AND MEDICAL DEVICES GROUP WEB SITE: http://www.dshs.state.tx.us/dmd/ ISSUANCE OF CERTIFICATES OF FREE SALE AND SANITATION AND/OR CERTIFICATES OF ORIGIN AND

More information

FDA Guidance Hot Topics: Pre-Submission Guidance Review AMDM Focus Meeting October 25, Elizabeth Hillebrenner, MSE OIR/CDRH/FDA

FDA Guidance Hot Topics: Pre-Submission Guidance Review AMDM Focus Meeting October 25, Elizabeth Hillebrenner, MSE OIR/CDRH/FDA FDA Guidance Hot Topics: Pre-Submission Guidance Review AMDM Focus Meeting October 25, 2013 Elizabeth Hillebrenner, MSE OIR/CDRH/FDA Updates to Guidance: Draft Final Broaden scope to address all types

More information

Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA

Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this

More information

Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary

Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary This document is scheduled to be published in the Federal Register on 08/17/2018 and available online at https://federalregister.gov/d/2018-17770, and on govinfo.gov 4164-01-P DEPARTMENT OF HEALTH AND

More information

The FDA Food Safety Modernization Act of 2009 Section-by-Section Summary

The FDA Food Safety Modernization Act of 2009 Section-by-Section Summary The FDA Food Safety Modernization Act of 2009 Section-by-Section Summary Title I Improving Capacity to Prevent Food Safety Problems Sec. 101. Inspection of Records Gives FDA expanded access to food facility

More information

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission This document is scheduled to be published in the Federal Register on 06/07/2018 and available online at https://federalregister.gov/d/2018-12223, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN

More information

May 12, 2016 MEMORANDUM. Certain provisions of FSMA are already in effect, namely: Mandatory recall authority (FSMA 206).

May 12, 2016 MEMORANDUM. Certain provisions of FSMA are already in effect, namely: Mandatory recall authority (FSMA 206). L A W O F F I C E S 7 0 0 T H I R T E E N T H S T R E E T, N. W. S U I T E 1 2 0 0 W A S H I N G T O N, D. C. 2 0 0 0 5-5 9 2 9 ( 2 0 2 ) 7 3 7-5 6 0 0 F A C S I M I L E ( 2 0 2 ) 7 3 7-9 3 2 9 w w w.

More information

Medical Device Recall Report FY FY 2012

Medical Device Recall Report FY FY 2012 Medical Device Recall Report FY 2003- FY 2012 Ann Ferriter Division of Analysis and Program Operations Office of Compliance Center for Devices and Radiological Health Questions Why did FDA draft the Medical

More information

Contains Nonbinding Recommendations. Draft Not for Implementation

Contains Nonbinding Recommendations. Draft Not for Implementation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Public Notification of Emerging Postmarket Medical Device Signals ( Emerging Signals ) Draft Guidance for Industry

More information

Guidance for Industry and Food and Drug Administration Staff

Guidance for Industry and Food and Drug Administration Staff Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff Guidance for Industry and Food and Drug Administration Staff Document

More information

A guide to PDUFA V. Focus US update. Regulatory Rapporteur Vol 9, No 11, November 2012

A guide to PDUFA V. Focus US update. Regulatory Rapporteur Vol 9, No 11, November 2012 10 A guide to PDUFA V Authors Virginia Beakes-Read JD RN, Executive Director, Global Regulatory Policy and Intelligence, Eisai, Inc; Florence Houn MD MPH FACP, Vice President, Regulatory Policy and Strategy,

More information

Food Safety Modernization Act (FSMA)

Food Safety Modernization Act (FSMA) Food Safety Modernization Act (FSMA) FDA FSMA Timeline July 29, 2009 House version passed Votes 283-142 Nov. 30, 2010 Senate version passed Votes 73-25 Dec. 19, 2010 Senate revised version passed Unanimous

More information

Take a Course of Action.

Take a Course of Action. Take a Course of Action. When you choose RAPS Online University, you ll be on track to expand your regulatory knowledge and advance your career. Our comprehensive learning provides an immersive experience

More information

FSMA User Guide. Food Safety Modernization Act Guide

FSMA User Guide. Food Safety Modernization Act Guide Food Safety Modernization Act Guide The Food Safety Modernization Act of 2011 (FSMA), the first major overhaul of food safety legislation in more than 70 years, gives FDA the new job of building a modern,

More information

FDA Outlook Seth A. Mailhot, Partner Lead, FDA Regulatory Practice

FDA Outlook Seth A. Mailhot, Partner Lead, FDA Regulatory Practice FDA Outlook 2017 Seth A. Mailhot, Partner Lead, FDA Regulatory Practice January,25, 2017 Overview Gaming the Elections Influence on FDA in 2017 Potential Congressional Activity PDUFA VI and MDUFA IV Restructuring

More information

POLICY OFFICE OF PHARMACEUTICAL QUALITY

POLICY OFFICE OF PHARMACEUTICAL QUALITY POLICY OFFICE OF PHARMACEUTICAL QUALITY Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls

More information

Medical Device Reporting for Manufacturers

Medical Device Reporting for Manufacturers Medical Device Reporting for Manufacturers DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Medical Device Reporting for Manufacturers Prepared by Division of

More information

November 7, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852

November 7, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 1300 North 17 th Street Suite 1752 Arlington, Virginia 22209 Tel: 703.841.3200 Fax: 703.841.3392 www.medicalimaging.org November 7, 2011 Division of Dockets Management (HFA-305) Food and Drug Administration

More information

FSMA Implementation FDA s Preventive Controls Rules

FSMA Implementation FDA s Preventive Controls Rules FSMA Implementation FDA s Preventive Controls Rules 2016 National Association of Dairy Regulatory Officials Annual Meeting July 11, 2016 CAPT Robert (Bob) Hennes, MST Leader Presentation Overview FSMA

More information

BE-595M Homework Assignment Due: 3/3/08

BE-595M Homework Assignment Due: 3/3/08 BE-595M Homework Assignment Due: 3/3/08 Attached is a Warning Letter issued to Applied Water Engineering, Inc., Salt Lake City, UT, for violations of the Quality System Regulations. The firm manufactures

More information

SJN DO CB Field Alert Reports. Edwin Ramos Director of Compliance Food and Drug Administration San Juan District Office

SJN DO CB Field Alert Reports. Edwin Ramos Director of Compliance Food and Drug Administration San Juan District Office SJN DO CB Field Alert Reports Edwin Ramos Director of Compliance Food and Drug Administration San Juan District Office SJN DO Mission Assuring that safe and effective drugs are available to the public

More information

The U.S. Food and Drug Administration s Food Safety Modernization Act: Current & Future Requirements

The U.S. Food and Drug Administration s Food Safety Modernization Act: Current & Future Requirements The U.S. Food and Drug Administration s Food Safety Modernization Act: Current & Future Requirements Beatrice Moreau Senior Regulatory Advisor Registrar Corp 144 Research Drive Hampton, Virginia USA 23666

More information

FWD Calibration Center Operator Certification Program

FWD Calibration Center Operator Certification Program FWD Calibration Center Operator Certification Program Program Requirements January 2018, Revision 2 Table of Contents 1. Introduction... 4 Additional Information... 4 Process Workflow... 4 2. Certification

More information

PDUFA V. New Review Program for NME NDAs and Original BLAs. Enhanced Communications with FDA and Sponsors. Beth Duvall

PDUFA V. New Review Program for NME NDAs and Original BLAs. Enhanced Communications with FDA and Sponsors. Beth Duvall PDUFA V New Review Program for NME NDAs and Original BLAs Enhanced Communications with FDA and Sponsors Beth Duvall Assoc Director for Regulatory Affairs FDA/CDER/Office of New Drugs September 25, 2013

More information

Solutions for GCP Compliance Challenges. September 23, 2015 Northwestern University IRB Brown Bag Session

Solutions for GCP Compliance Challenges. September 23, 2015 Northwestern University IRB Brown Bag Session Solutions for GCP Compliance Challenges September 23, 2015 Northwestern University IRB Brown Bag Session PAMELA MASON, MPH Vice President, Mason Professional Services, LLC Adjunct Faculty, Northwestern

More information

Solutions for GCP Compliance Challenges

Solutions for GCP Compliance Challenges Solutions for GCP Compliance Challenges September 23, 2015 Northwestern University IRB Brown Bag Session PAMELA MASON, MPH Vice President, Mason Professional Services, LLC Adjunct Faculty, Northwestern

More information

Latham & Watkins Corporate Department

Latham & Watkins Corporate Department Number 1133 January 27, 2011 Client Alert Latham & Watkins Corporate Department FDA Announces Actions Designed to Improve the 510(k) Premarket Clearance Process Importantly, however, the Agency s identified

More information

The Prescription Drug User Fee Act (PDUFA): Background and Issues for PDUFA IV Reauthorization

The Prescription Drug User Fee Act (PDUFA): Background and Issues for PDUFA IV Reauthorization Order Code RL33914 The Prescription Drug User Fee Act (PDUFA): Background and Issues for PDUFA IV Reauthorization March 13, 2007 Susan Thaul Specialist in the Regulation of Prescription Drugs and Biologics

More information

WATER SUPPLY RESERVE FUND

WATER SUPPLY RESERVE FUND Introduction Senate Bill 06-179, adopted by the 2006 General Assembly, created the Water Supply Reserve Account, now called the Water Supply Reserve Fund (per SB13-181) (WSRF). The legislation, codified

More information

Chapter 48 - Bioresearch Monitoring

Chapter 48 - Bioresearch Monitoring COMPLIANCE GUIDANCE MANUAL Chapter 48 - Bioresearch Monitoring Subject SPONSORS, CONTRACT RESEARCH ORGANIZATIONS AND MONITORS Implementation Date February 21, 2001 Completion Date Continuing Product Codes

More information

Contains Nonbinding Recommendations

Contains Nonbinding Recommendations Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China: Guidance for Industry

More information

Chapter 21. FDA Inspections

Chapter 21. FDA Inspections Chapter 21 FDA Inspections Jennifer M. Thomas & Douglas B. Farquhar 21:1 Role of Inspections 21:1.1 Overview 21:1.2 FDA s Reasons to Inspect 21:1.3 Potential Outcomes of Inspections 21:2 FDA Authority

More information

*Applicable to: Beaumont Health. Document Type: Policy

*Applicable to: Beaumont Health. Document Type: Policy Owner: *For This Document, Includes: Beaumont Corporate Shared Services Beaumont Hospital, Dearborn Beaumont Hospital, Farmington Hills Beaumont Hospital, Grosse Pointe Beaumont Hospital, Royal Oak Beaumont

More information

Requirements for Tax-Exempt Hospital Billing and Collection Practices Under the ACA

Requirements for Tax-Exempt Hospital Billing and Collection Practices Under the ACA Requirements for Tax-Exempt Hospital Billing and Collection Practices Under the ACA Member Briefing, October 2016 Sponsored by the Tax and Finance Practice Group. Co-sponsored by the Academic Medical Centers

More information

Version 1.1, 6/30/2016 Guidance for Abbreviated IDE Requirements

Version 1.1, 6/30/2016 Guidance for Abbreviated IDE Requirements Version 1.1, 6/30/2016 Guidance for Abbreviated IDE Requirements The Principal Investigator of a study that is requesting an abbreviated IDE for use of a non-significant risk device must attest to the

More information

FDA SEATTLE DISTRICT REGULATORY UPDATE

FDA SEATTLE DISTRICT REGULATORY UPDATE FDA SEATTLE DISTRICT REGULATORY UPDATE SEAFOOD PRODUCTS ASSOCIATION PROCESSORS WORKSHOP SEATTLE, WASHINGTON MARCH 10, 2015 MIRIAM R. BURBACH SEATTLE DISTRICT DIRECTOR 1 FDA SEATTLE DISTRICT REGULATORY

More information

GOVERNMENT OF THE RUSSIAN FEDERATION. DECREE of December 27, 2012 N On the Rules STATE REGISTRATION OF MEDICAL PRODUCTS

GOVERNMENT OF THE RUSSIAN FEDERATION. DECREE of December 27, 2012 N On the Rules STATE REGISTRATION OF MEDICAL PRODUCTS GOVERNMENT OF THE RUSSIAN FEDERATION DECREE of December 27, 2012 N 1416 On the Rules STATE REGISTRATION OF MEDICAL PRODUCTS In accordance with Article 38 of the Federal Law "On the basis of health protection

More information

Determining and Reporting Adverse Events vs. Product Complaints

Determining and Reporting Adverse Events vs. Product Complaints Determining and Reporting Adverse Events vs. Product Complaints Pharma Perspective: Jacqueline Grissinger Director, Office of Consumer Medical Safety Johnson & Johnson Medical Device Perspective: Lisa

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Electronic Submission of Lot Distribution Reports for Biological Products This guidance is for immediate implementation. FDA is issuing this guidance for immediate implementation

More information

FDA HAS MADE PROGRESS

FDA HAS MADE PROGRESS Department of Health and Human Services OFFICE OF INSPECTOR GENERAL FDA HAS MADE PROGRESS ON OVERSIGHT AND INSPECTIONS OF MANUFACTURERS OF GENERIC DRUGS Daniel R. Levinson Inspector General May 2015 OEI-01-13-00600

More information

Update on FSMA Implementation. Rebecca Buckner May 24, 2016

Update on FSMA Implementation. Rebecca Buckner May 24, 2016 Update on FSMA Implementation Rebecca Buckner May 24, 2016 Presentation Overview FSMA Implementation Rulemaking and Industry Guidance - Focus on the Preventive Controls Rules FSMA Implementation Guiding

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Self-Identification of Generic Drug Facilities, Sites, and Organizations DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions

More information

Learning Objectives. Scope of the Problem 9/20/2012. By the end of the presentation the audience members will be able to:

Learning Objectives. Scope of the Problem 9/20/2012. By the end of the presentation the audience members will be able to: On Back Order RT Whiteman, Pharm.D Pharmacy Practice Resident St. Luke s Boise Medical Center Learning Objectives By the end of the presentation the audience members will be able to: Explain the most likely

More information

SECNAVINST E ONR Dec 2017 SECNAV INSTRUCTION E. From: Secretary of the Navy. Subj: HUMAN RESEARCH PROTECTION PROGRAM

SECNAVINST E ONR Dec 2017 SECNAV INSTRUCTION E. From: Secretary of the Navy. Subj: HUMAN RESEARCH PROTECTION PROGRAM ONR 343 SECNAV INSTRUCTION 3900.39E From: Secretary of the Navy Subj: HUMAN RESEARCH PROTECTION PROGRAM Encl: (1) Changes (2) References (3) Responsibilities (4) Procedures (5) Definitions (6) Reports

More information

Regulatory Control of Diagnostics in Tanzania. Hiiti Sillo Ag. Director General Tanzania Food and Drugs Authority

Regulatory Control of Diagnostics in Tanzania. Hiiti Sillo Ag. Director General Tanzania Food and Drugs Authority 6 th Consultative Stakeholders Meeting on UN PQ of Medicines, Diagnostics and Vaccines 4-5 April, 2011, Geneva, Switzerland Regulatory Control of Diagnostics in Tanzania Hiiti Sillo Ag. Director General

More information

RULES OF TENNESSEE DEPARTMENT OF LABOR AND WORKFORCE DEVELOPMENT WORKERS COMPENSATION DIVISION

RULES OF TENNESSEE DEPARTMENT OF LABOR AND WORKFORCE DEVELOPMENT WORKERS COMPENSATION DIVISION RULES OF TENNESSEE DEPARTMENT OF LABOR AND WORKFORCE DEVELOPMENT WORKERS COMPENSATION DIVISION CHAPTER 0800-02-25 WORKERS COMPENSATION MEDICAL TREATMENT TABLE OF CONTENTS 0800-02-25-.01 Purpose and Scope

More information

CDER Small Business and Industry Assistance (SBIA)

CDER Small Business and Industry Assistance (SBIA) CDER Small Business and Industry Assistance (SBIA) Brenda Stodart, PharmD, BCGP Director CDER Small Business and Industry Assistance (SBIA) Division of Drug Information (DDI) Center for Drug Evaluation

More information

AMENDED WARNING LETTER CIN

AMENDED WARNING LETTER CIN Department of Health and Human Services Public Health Service Food and Drug Administration Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700

More information

Food Safety Modernization Act

Food Safety Modernization Act Aon Risk Solutions Food Safety Modernization Act Highlights and Implications for Your Business Risk. Reinsurance. Human Resources. On January 4, 2011, President Obama signed the Food Safety Modernization

More information

FDA s Office of Regulatory Affairs: Violation Trends & Medical Device Update

FDA s Office of Regulatory Affairs: Violation Trends & Medical Device Update FDA s Office of Regulatory Affairs: Violation Trends & Medical Device Update Ginger M. Sykes Supervisory Consumer Safety Officer Salt Lake City Resident Post Office of Regulatory Affairs U.S. Food and

More information

FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM

FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM 7348.810 CHAPTER 48 Bioresearch Monitoring SUBJECT: SPONSORS, CONTRACT RESEARCH ORGANIZATIONS AND MONITORS REVISION: IMPLEMENTATION

More information

Bureau of Waste Management

Bureau of Waste Management Standard Operating Procedures for Processing Municipal and Residual Waste Major Permit Modifications, not Including Increases in Capacity Applications for Landfills, Resource Recovery Facilities, Transfer

More information

Notice of Privacy Practices for Protected Health Information (PHI)

Notice of Privacy Practices for Protected Health Information (PHI) Notice of Privacy Practices for Protected Health Information (PHI) Dermatology Associates of Colorado, PC THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN

More information

FDA's OMB supporting document for QSr recordkeeping, 7/20/01, page 1 of 7

FDA's OMB supporting document for QSr recordkeeping, 7/20/01, page 1 of 7 FDA's OMB supporting document for QSr recordkeeping, 7/20/01, page 1 of 7 DISCLAIMER: This document was prepared by editing the converted PDF file supporting FDA's request to OMB for continuation of record

More information

FDA Reportable Food Registry. David E. Gombas, Ph.D. United Fresh Produce Association September 21, 2009

FDA Reportable Food Registry. David E. Gombas, Ph.D. United Fresh Produce Association September 21, 2009 FDA Reportable Food Registry David E. Gombas, Ph.D. United Fresh Produce Association September 21, 2009 Reportable Food Registry Part of the FDA Amendments Act Signed into law on September 27, 2007 Amends

More information

ADVANCED PLASTIC SURGERY, PLLC. NOTICE OF PRIVACY PRACTICES

ADVANCED PLASTIC SURGERY, PLLC. NOTICE OF PRIVACY PRACTICES Effective Date: July 1 st 2013 ADVANCED PLASTIC SURGERY, PLLC. NOTICE OF PRIVACY PRACTICES THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO

More information

FDA Vision for Innovative Surveillance of Orthopedic Implants

FDA Vision for Innovative Surveillance of Orthopedic Implants FDA Vision for Innovative Surveillance of Orthopedic Implants Danica Marinac-Dabic, MD, PhD Director, CDRH Division of Epidemiology Head, FDA ICOR Initiative Total and Resurfacing Hip Systems: Post-Approval

More information

Pediatric Medical Devices: The FDA Postmarket Perspective

Pediatric Medical Devices: The FDA Postmarket Perspective Pediatric Medical Devices: The FDA Postmarket Perspective Thomas P. Gross, MD, MPH Deputy Office Director Office of Surveillance and Biometrics Center for Devices and Radiological Health Pediatric Safety

More information

Food Safety Protocol, 2016

Food Safety Protocol, 2016 Ministry of Health and Long-Term Care Food Safety Protocol, 2016 Population and Public Health Division, Ministry of Health and Long-Term Care May 2016 Preamble The Ontario Public Health Standards (OPHS)

More information

Karen W. Dyer MT(ASCP), DLM Director, Division of Laboratory Services Centers for Medicare & Medicaid Services CLIA

Karen W. Dyer MT(ASCP), DLM Director, Division of Laboratory Services Centers for Medicare & Medicaid Services CLIA Karen W. Dyer MT(ASCP), DLM Director, Division of Laboratory Services Centers for Medicare & Medicaid Services Objectives Basics Certificate of Waiver (CoW) laboratories Triagency responsibilities FDA

More information

Real-World Evidence: A CDRH Perspective

Real-World Evidence: A CDRH Perspective Real-World Evidence: A CDRH Perspective Karen Ulisney, MSN, CRNP Policy Analyst, Clinical Trials Program Office of Device Evaluation CDRH, FDA Case for Quality Forum July 20, 2017 Patients are at the Heart

More information

Part 1: Employment Restrictions After Leaving DoD: Personal Lifetime Ban

Part 1: Employment Restrictions After Leaving DoD: Personal Lifetime Ban POST-GOVERNMENT SERVICE EMPLOYMENT RESTRICTIONS (RULES AFFECTING YOUR NEW JOB AFTER DoD) For Military Personnel E-1 through O-6 and Civilian Personnel who are not members of the Senior Executive Service

More information

1. Department of Defense (DoD) Human Subjects Protection Regulatory Requirements

1. Department of Defense (DoD) Human Subjects Protection Regulatory Requirements Information for Investigators: Headquarters, U.S. Special Operations Command Human Research Protection Office (HRPO) Human Research Protections Regulatory Requirements 1. Department of Defense (DoD) Human

More information

Office of Science, Technology & Innovation N.C. Department of Commerce 1326 Mail Service Center Raleigh, North Carolina

Office of Science, Technology & Innovation N.C. Department of Commerce 1326 Mail Service Center Raleigh, North Carolina Proposed Amendments to Guidelines for the North Carolina Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase I Matching Funds Program ( the Program ) As required

More information

2015 Annual FDA Medical Device Quality System Data. Inspections, FDA Form 483 Observations, and Warning Letter Citations

2015 Annual FDA Medical Device Quality System Data. Inspections, FDA Form 483 Observations, and Warning Letter Citations 2015 Annual FDA Medical Device Quality System Data Inspections, FDA Form 483 Observations, and Warning Letter Citations Why is FDA making these data available? In support of the FDA s Transparency and

More information

Establishment of the FDA Office of Patient Affairs

Establishment of the FDA Office of Patient Affairs Establishment of the FDA Office of Patient Affairs Policy Proposal: With the advent of new and innovative patient engagement programs within the Food and Drug Administration (FDA), a growing need for greater

More information

Topic: CAP s Legislative Proposal for Laboratory-Developed Tests (LDT) Date: September 14, 2015

Topic: CAP s Legislative Proposal for Laboratory-Developed Tests (LDT) Date: September 14, 2015 Topic: CAP s Legislative Proposal for Laboratory-Developed Tests (LDT) Date: September 14, 2015 1. What are the CAP s views on the regulatory oversight of laboratory-developed tests (LDTs)? 2. How are

More information

Standard Operating Procedures for Processing Municipal and Residual Waste General Permit Applications. Bureau of Waste Management

Standard Operating Procedures for Processing Municipal and Residual Waste General Permit Applications. Bureau of Waste Management Standard Operating Procedures for Processing Municipal and Residual Waste General Permit Applications Bureau of Waste Management Revised 9/18/2014 Table of Contents Section Page Number I. Receipt of Application...

More information

Weber Family Chiropractic PC Patient Right to Request Restrictions on Use and Disclosure of Health Information

Weber Family Chiropractic PC Patient Right to Request Restrictions on Use and Disclosure of Health Information Weber Family Chiropractic PC Patient Right to Request Restrictions on Use and Disclosure of Health Information Policy No.: 6 Issue Date: 04/14/03 Revision Date: 10/01/2013 Approvals: Dr. Scott Weber Title:

More information

Request for Proposal PROFESSIONAL AUDIT SERVICES

Request for Proposal PROFESSIONAL AUDIT SERVICES Request for Proposal PROFESSIONAL AUDIT SERVICES FORENSIC AUDIT OF CITY S FINANCE DEPARTMENT, URA ACCOUNTS AND DEVELOPMENT AUTHORITY ACCOUNTS PROCEDURES CITY OF FOREST PARK TABLE OF CONTENTS I. INTRODUCTION

More information

Identification and Protection of Unclassified Controlled Nuclear Information

Identification and Protection of Unclassified Controlled Nuclear Information ORDER DOE O 471.1B Approved: Identification and Protection of Unclassified Controlled Nuclear Information U.S. DEPARTMENT OF ENERGY Office of Health, Safety and Security DOE O 471.1B 1 IDENTIFICATION

More information

Medical Device Reporting. FD&C Act CFR Direct Final Rule 2/28/05. As amended by:

Medical Device Reporting. FD&C Act CFR Direct Final Rule 2/28/05. As amended by: Medical Device Reporting Direct Final Rule 2/28/05 FD&C Act 519 As amended by: Safe Medical Devices Act of 1990 Medical Device Amendments of 1992 FDA Modernization Act of 1997 Authority to require manufacturers,

More information

POLICY AND PROCEDURES. Office of Generic Drugs and Office of Pharmaceutical Quality. Table of Contents

POLICY AND PROCEDURES. Office of Generic Drugs and Office of Pharmaceutical Quality. Table of Contents POLICY AND PROCEDURES Office of Generic Drugs and Office of Pharmaceutical Quality Communications with Industry with respect to pre-gdufa Year Three Abbreviated New Drug Applications Table of Contents

More information

ANVISA - Enhancing marketing authorization of drugs and medical devices in accordance to the international best practices

ANVISA - Enhancing marketing authorization of drugs and medical devices in accordance to the international best practices ANVISA - Enhancing marketing authorization of drugs and medical devices in accordance to the international best practices Balbiana Verazez Sampaio Oliveira AGENDA 1. Strategic Plan 2016-2019 objectives

More information

CHAPTER Senate Bill No. 400

CHAPTER Senate Bill No. 400 CHAPTER 98-91 Senate Bill No. 400 An act relating to state financial accountability; creating the Florida Single Audit Act; providing intent and findings; creating s. 216.3491, F.S.; providing purposes

More information

1 of 13 DOCUMENTS. NEW JERSEY ADMINISTRATIVE CODE Copyright 2016 by the New Jersey Office of Administrative Law

1 of 13 DOCUMENTS. NEW JERSEY ADMINISTRATIVE CODE Copyright 2016 by the New Jersey Office of Administrative Law Page 1 1 of 13 DOCUMENTS Title 10, Chapter 190 -- Chapter Notes N.J.A.C. 10:190 (2016) Page 2 2 of 13 DOCUMENTS 10:190-1.1 Scope and purpose N.J.A.C. 10:190-1.1 (2016) (a) The purpose of this subchapter

More information

OPDP Update on Oversight of Prescription Drug Promotion

OPDP Update on Oversight of Prescription Drug Promotion OPDP Update on Oversight of Prescription Drug Promotion Thomas Abrams Director Office of Prescription Drug Promotion Food and Drug Administration October 20, 2016 Topics Policy and Guidance Development

More information

Open DFARS Cases as of 5/10/2018 2:29:59PM

Open DFARS Cases as of 5/10/2018 2:29:59PM Open DFARS Cases as of 2:29:59PM 2018-D032 215 (R) Repeal of DFARS clause "Pricing Adjustments" 2018-D031 231 (R) Repeal of DFARS clause "Supplemental Cost Principles" 2018-D030 216 (R) Repeal of DFARS

More information

DEPARTMENT OF HUMAN SERVICES AGING AND PEOPLE WITH DISABILITIES DIVISION OREGON ADMINISTRATIVE RULES CHAPTER 411 DIVISION 58

DEPARTMENT OF HUMAN SERVICES AGING AND PEOPLE WITH DISABILITIES DIVISION OREGON ADMINISTRATIVE RULES CHAPTER 411 DIVISION 58 DEPARTMENT OF HUMAN SERVICES AGING AND PEOPLE WITH DISABILITIES DIVISION OREGON ADMINISTRATIVE RULES 411-058-0000 Definitions CHAPTER 411 DIVISION 58 LONG TERM CARE REFERRAL SERVICES Unless the context

More information

Commodity Credit Corporation and Foreign Agricultural Service. Notice of Funding Availability: Inviting Applications for the Emerging Markets

Commodity Credit Corporation and Foreign Agricultural Service. Notice of Funding Availability: Inviting Applications for the Emerging Markets This document is scheduled to be published in the Federal Register on 05/09/2018 and available online at https://federalregister.gov/d/2018-09866, and on FDsys.gov Billing Code 3410 10 DEPARTMENT OF AGRICULTURE

More information

65-1,201. Definitions. As used in the residential childhood lead poisoning prevention act: History: L. 1999, ch. 99, 2; Apr. 22

65-1,201. Definitions. As used in the residential childhood lead poisoning prevention act: History: L. 1999, ch. 99, 2; Apr. 22 65-1,200. Citation of act. K.S.A. 65-1,200 to 65-1,214, inclusive, of this act shall be known and may be cited as the residential childhood lead poisoning prevention act. History: L. 1999, ch. 99, 2; Apr.

More information

AFDO FINAL COMMITTEE REPORT

AFDO FINAL COMMITTEE REPORT 2013-2014 AFDO FINAL COMMITTEE REPORT International & Governmental Relations Committee *Chair: Mark Roh, U.S. Food & Drug Administration, Oakland, CA Chair: Bob Scales, Health Products & Food Branch, Health

More information

DOD Anti-Counterfeit Rule Requires Immediate Action --By Craig Holman, Evelina Norwinski and Dana Peterson, Arnold & Porter LLP

DOD Anti-Counterfeit Rule Requires Immediate Action --By Craig Holman, Evelina Norwinski and Dana Peterson, Arnold & Porter LLP Published by Government Contracts Law360 on May 19, 2014. Also ran in Aerospace & Defense Law360 and Public Policy Law360. DOD Anti-Counterfeit Rule Requires Immediate Action --By Craig Holman, Evelina

More information