FDA s Office of Regulatory Affairs: Violation Trends & Medical Device Update
|
|
- Horatio Hampton
- 6 years ago
- Views:
Transcription
1 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 Drug Administration ginger.sykes@fda.hhs.gov October 6 th, Utah Life Science Summit With thanks to Bryan Love, Medical Device Supervisory Consumer Safety Officer, Denver District
2 Agenda Center for Devices & Radiological Health Strategic Priorities Unique Device Identification (UDI) Requirements Labeling Data Submission Violation Trends (Medical Device & Drug) 2
3 CDRH Strategic Priorities Establish a National Evaluation System for Medical Devices Goal: Increase access to real-world evidence to support regulatory decision making Goal: Increase the use of real-world evidence to support regulatory decision making Partner with Patients Goal: Promote a culture of meaningful patient engagement by facilitating CDRH interaction with patients Goal: Increase use and transparency of patient input as evidence in our decision making Promote a Culture of Quality and Organizational Excellence Goal: Strengthen FDA s culture of quality within the Center for Devices and Radiological Health Goal: Strengthen product and manufacturing quality within the medical device ecosystem 3
4 Establish a National Evaluation System for Medical Devices GOAL: INCREASE ACCESS TO REAL WORLD EVIDENCE TO SUPPORT REGULATORY DECISION MAKING By December 31, 2016, gain access to 25 million electronic patient records (from national and international clinical registries, claims data, and EHRs) with device identification. By December 31, 2017, gain access to 100 million electronic patient records with device identification. GOAL: INCREASE THE USE OF REAL-WORLD EVIDENCE TO SUPPORT REGULATORY DECISION MAKING By December 31, 2016, increase by 40 percent the number of premarket and postmarket regulatory decisions that leverage real-world evidence (compared to FY2015 baseline) By December 31, 2017, increase by 100 percent the number of premarket and postmarket regulatory decisions that leverage real-world evidence (compared to FY2015 baseline) 4
5 Device Identification Unique Device Identifier (UDI) Rule When: September 24 th, 2013 Final Rule 78 FR What is it: It requires the labels and device packages of medical devices distributed in the United States include a unique device identifier (UDI), unless we grant an exception or alternative to UDI label requirements. Additional Requirements: Product information will need to be submitted to FDA s Global Unique Device Identification Database (known as the GUDID). 5
6 Health Objectives served by the UDI Rule: A way to obtain accurate information about a device Ability to readily access important information hence reducing medical errors More accurate reporting, reviewing, and analyzing of AE reports Provides a standard and clear way to document device use in electronic health records, clinical information systems, claims data sources and registries Enable manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls Provides a foundation for a global, secure distribution chain that will help address counterfeiting and diversion, and prepare for medical emergencies 6
7 What is a UDI? 21 CFR Unique Device Identification Found on the device label, packaging or, in some cases, on the device itself Both in plain text and machine readable format (AIDC) Identifies device through distribution & use 7
8 Example UDI = DI + PI 8
9 Device Identifier (DI) 9
10 Production Identifier (PI) 10
11 How do I get a UDI? You have to go through an Issuing Agency (21 CFR 830) An issuing agency operates a system for issuing UDIs to labelers. The UDI rule requires all UDIs to be issued under a system operated by an FDA-accredited issuing agency. FDA accreditation requires that the issuing agency s system conforms to certain international consensus standards. 11
12 Link to UDI website UniqueDeviceIdentification/default.htm 12
13 Issuing Agencies Currently there are three FDA accredited Issuing Agencies to choose from: GS1 (initial accreditation granted through: December 17, 2016) Health Industry Business Communications Council (HIBCC) (initial accreditation granted through: December 26, 2016) ICCBBA (initial accreditation granted through: February 12, 2017) 13
14 These are Not Packages and Do Not Require a UDI Wrapping intended to protect Pallets Crates 14
15 Compliance Dates for UDI Requirements 15
16 Global Unique Device Identification Database (GUDID) Repository of key device identification information Contains ONLY the DI PIs are not submitted to or stored in the GUDID 16
17 17
18 Link to GUDID Guidance DeviceIdentification/GlobalUDIDatabaseGUDID/ucm htm 18
19 Top 4 Medical Device Observations Fiscal FY15 vs. FY16 Fiscal Year* Count Reference No. Citation Text FY FY FY FY CFR (a) 21 CFR (a) Procedures for corrective and preventive action have not been [adequately] established. Specifically, *** Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established. Specifically,*** FY CFR FY CFR (a) FY CFR (a) FY CFR Written MDR procedures have not been [developed] [maintained] [implemented]. Specifically, *** A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures. Specifically, *** Procedures have not been [adequately] established to control product that does not conform to specified requirements. Specifically, *** Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established. Specifically, *** *Fiscal Year is from October 1 st to September 30 th. 19
20 Top 4 Drug Observations Fiscal FY15 vs. FY16 Fiscal Year Count Reference No. Citation Text FY FY FY FY FY FY CFR (d) 21 CFR (b) 21 CFR The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, *** Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity. Specifically, *** There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. Specifically, *** FY CFR (a) FY CFR (b) Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. Specifically, *** Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, *** 20
21 Questions? 21
22
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 informationCollaborative Communities: It Really Does Take a Village
Collaborative Communities: It Really Does Take a Village April 25 th Karen Conway, GHX Denise Downing, AORN Ellenmary Martin, Dukal Corp. Terrie Reed, FDA Linda Rouse-O Neill, HIDA Slide 1 Slide 2 2018
More informationCenter 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 informationComplaint 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 informationPREVENT YOUR DIETARY SUPPLEMENT LABORATORY FROM BECOMING A COMPLIANCE RISK. Marian Boardley 2013
PREVENT YOUR DIETARY SUPPLEMENT LABORATORY FROM BECOMING A COMPLIANCE RISK Marian Boardley 2013 APPLICABLE GMP S: DIETARY SUPPLEMENT LABS Subparts for laboratory operations and testing, 21 CFR 111 D Equipment
More informationSJN 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 informationBristol Myers Squibb Holdings Pharma., Ltd.
Bristol Myers Squibb Holdings Pharma., Ltd. Department of Health and Human Services Public Health Service Food and Drug Administration 466 Fernandez Juncos Avenue Puerta De Tierra San Juan, Puerto Rico
More information2015 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 informationAuthorized Personnel to Review
October 31, 2017 Page 1 of 7 All documents developed or maintained for the Manufactured Food Regulatory Program Standards ( MFRPS ) are listed below. For each document, the following information is included:
More informationComplaints Investigation and Review. Dr. Ademola Daramola International Relations Specialist Drugs US FDA India Office New Delhi February 22nd 2018
Complaints Investigation and Review Dr. Ademola Daramola International Relations Specialist Drugs US FDA India Office New Delhi February 22nd 2018 Information presented in this presentation does not represent
More informationBE-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 informationSTATEMENT. JEFFREY SHUREN, M.D., J.D. Director, Center for Devices and Radiological Health Food and Drug Administration
STATEMENT JEFFREY SHUREN, M.D., J.D. Director, Center for Devices and Radiological Health Food and Drug Administration Institute of Medicine Committee on Patient Safety and Health Information Technology
More informationAMENDED 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 informationModernizing Hospital Adverse Event Reporting
Modernizing Hospital Adverse Event Reporting 14 December 2016 Sarah H. Stec Not Legal Advice For Informational and Educational Purposes Only Firm Overview More than 1,500 lawyers in 46 offices across 21
More informationGAO 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 informationSolutions 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 informationSolutions 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 informationMedical 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 informationLatham & 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 informationMedical 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 informationFDA'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 informationSECTION HOSPITALS: OTHER HEALTH FACILITIES
SECTION.1400 - HOSPITALS: OTHER HEALTH FACILITIES 21 NCAC 46.1401 REGISTRATION AND PERMITS (a) Registration Required. All places providing services which embrace the practice of pharmacy shall register
More informationAdministrative Policies and Procedures. Policy No.: N/A Title: Medical Equipment Management Plan
Administrative Policies and Procedures Originating Venue: Environment of Care Title: Medical Equipment Management Plan Cross Reference: Date Issued: 11/14 Date Reviewed: Date: Revised: Attachment: Page
More informationPediatric 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 informationNSF Dietary Supplement Complete Service Offering. Experts in supplement auditing, consulting, testing and training.
NSF Dietary Supplement Complete Service Offering Experts in supplement auditing, consulting, testing and training www.nsf.org Dietary Supplement Quality Training NSF Dietary Supplement Quality Training
More informationChanges to QSR. The table below provides a history of changes to FDA s Quality System Regulation (QSR)
Changes to QSR The table below provides a history of changes to FDA s Quality System Regulation (QSR) The citation is to the Federal R: the first number is the volume, FR indicates the Federal Register,
More informationCDRH Device Quality Update March 17, 2015
CDRH Device Quality Update March 17, 2015 William C. MacFarland FDA/CDRH/OC/Division of Manufacturing and Quality 1 Agenda Themes for 2015 FDA Commissioner s Program Alignment FDA s Case for Quality 2015
More informationMDUFA 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 informationReal-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 informationPostmarketing 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 informationGOOD LABORATORY PRACTICES (GLP) OVERVIEW
GOOD LABORATORY PRACTICES (GLP) OVERVIEW MN ASQ MEETING - 4/11/17 TERRY RICKE COMPLIANCE / AUDIT SPECIALIST MEDTRONIC PHYSIOLOGICAL RESEARCH LABS TERRY.RICKE@MEDTRONIC.COM WHAT IS GLP? Good Laboratory
More informationStandards and Medical Device Regulation Roundtable. Seoul South Korea. 21 October ASTM International
Standards and Medical Device Regulation Roundtable Seoul South Korea 21 October 2014 FDA s Use of Voluntary Consensus Standards Scott Colburn, Director CDRH Standards Program Office of the Center Director,
More informationWorld Accreditation Day Webinar
Welcome to ANSI s World Accreditation Day Webinar PLEASE NOTE: Everyone is MUTED; please send questions via Questions option Presenter Name Title Q&A follows the presentations Thanks for Your Participation
More informationMedical 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 informationAre You Ready for FSMA? Janet Raddatz VP Quality & Food Safety Systems Sargento Foods Inc. WAFP June 12, 2013
Are You Ready for FSMA? Janet Raddatz VP Quality & Food Safety Systems Sargento Foods Inc. WAFP June 12, 2013 New Responsibilities for Food Companies Impacting daily operations in all registered facilities,
More informationCompounded Sterile Preparations Pharmacy Content Outline May 2018
Compounded Sterile Preparations Pharmacy Content Outline May 2018 The following domains, tasks, and knowledge statements were identified and validated through a role delineation study. The proportion of
More informationVersion 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 informationNovember 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 informationFDA 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 informationReceived 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 informationThe 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 informationCertified Healthcare Safety Nursing (CHSN) Examination Blueprint/Outline
Certified Healthcare Safety Nursing (CHSN) Examination Blueprint/Outline (Effective October 1, 2017) Exam Domains 135 Items 1. Patient Safety Fundamentals 54 Items/40% 2. Healthcare Safety Management 54
More informationConnie Hoy October 2013
Connie Hoy October 2013 Warning letter issued to firm for complaint handling Failure to report within 30 days Failure to implement adequate procedures Failure to establish standard review process No procedure
More informationNJ Dept of Health Central Service Standards SUBCHAPTER 8. CENTRAL SERVICE. 8:43G-8.1 Central service policies and procedures
NJ Dept of Health Central Service Standards SUBCHAPTER 8. CENTRAL SERVICE 8:43G-8.1 Central service policies and procedures (a) The hospital's central service shall have written policies and procedures
More informationDraft 11/3/2017. Crosswalk - Requirements for Foodborne Illness Training Programs Based on Standard 5
Draft 11/3/2017 Crosswalk - Requirements for Training Programs Based on Standard 5 Introduction: The 2012 2014 Interdisciplinary Training Committee (IFITC) obtained the Food Safety and Modernization Act
More informationCrosswalk - Requirements for Foodborne Illness Training Programs Based on Standard 5
Crosswalk - Requirements for Training Programs Based on Standard 5 Introduction: The 2012 2014 Interdisciplinary Training Committee (IFITC) obtained the FSMA 205 C(1) Phases of a Food Incident (CIFOR/RRT/MFRPS/VNRFRPS
More informationCenter for Devices and Radiological Health; Medical Devices and Combination Products;
This document is scheduled to be published in the Federal Register on 12/26/2017 and available online at https://federalregister.gov/d/2017-27650, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
More information10/4/12. Controlled Substances Dispensing Issues and Solutions. Objectives. Financial Disclosure
Controlled Substances Dispensing Issues and Solutions Ronald W. Buzzeo, R.Ph. Chief Compliance Officer November 7, 2012 CE Code: Financial Disclosure I have no actual or potentially relevant financial
More informationMerit-Based Incentive Payment System (MIPS) Advancing Care Information Performance Category Measure 2018 Performance Period
Merit-Based Incentive Payment System (MIPS) Advancing Care Information Performance Category Measure 2018 Performance Period Objective: Measure: Measure ID: Public Health and Clinical Data Registry Reporting
More informationOPDP 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 informationInspections, Compliance, Enforcement, and Criminal Investigations
Inspections, Compliance, Enforcement, and Criminal Investigations Husain, Mustafa M, M.D. 23-Jul-08 Department of Health and Human Services Public Health Service Food and Drug Administration Center for
More informationMay 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 informationThe Mammography Quality Standards Act Final Regulations Document #2
Compliance Guidance The Mammography Quality Standards Act Final Regulations Document #2 Document issued on: February 25, 2000 This document supersedes document Draft Compliance Guidance March 19, 1999
More informationGeneral Administration GA STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility
General Administration GA 102.01 STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility Approval: Nancy Paris, MS, FACHE President and CEO (17 July 2014) (Signature and
More informationFDA Medical Device Regulations vs. ISO 14155
Vol. 11, No. 9, September 2015 Happy Trials to You FDA Medical Device Regulations vs. ISO 14155 By Shawn Kennedy Medical device clinical trials must comply with 21 CFR Parts 11 (Electronic Records), 50
More informationCLOSE OUT VISIT REPORT (NO CRF TO MONITOR)
Date: Page: 1 of 8 CLOSE OUT VISIT REPORT (NO CRF TO MONITOR) Protocol: PI Name: PI Address: Date of Visit: Monitor(s): Other Sponsor Personnel Present: Site Personnel Present at Visit (include names and
More informationCDRH Standards Program
Standards Scott Colburn Deputy Director Standards Management Staff FDA/CDRH/OSEL 1 CDRH Standards Program Standards needs/priorities New projects Travel / Travel priorities Standards review Standards ballot
More informationSPONSOR-INVESTIGATOR ROLES & RESPONSIBILITIES IN DEVICE TRIALS
SPONSOR-INVESTIGATOR ROLES & RESPONSIBILITIES IN DEVICE TRIALS Food and Drug Administration Center for Devices and Radiological Health Office of Compliance Division of Bioresearch Monitoring Doreen Kezer,
More informationDepartment of Code Compliance
Department of Code Compliance Department of Code Compliance Action Plan Briefing presented to the Dallas City Council Quality of Life Committee June 26, 2006 In April & September of 2004, the Public Safety
More informationFDA Reauthorization Act of 2017 (FDARA)
FDA Reauthorization Act of 2017 (FDARA) April 4, 2018 PRESENTED BY: Jessica Ringel Counsel FDA & Life Sciences Practice Group King & Spalding LLP (202) 626-9259 jringel@kslaw.com FDA Reauthorization Act
More informationInteractive 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 informationApril 17, Edition of the Joint Commission International Accreditation. SUBJECT: MITA Feedback on the 5 th Standards for Hospitals
1300 North 17 th Street Suite 1752 Arlington, Virginia 22209 Tel: 703.841.3200 Fax: 703.841.3392 www.medicalimaging.org April 17, 2013 Paul vanostenberg, DDS, MS Vice President Accreditation and Standards
More informationPOCKET GUIDE TO THE ACCREDITATION STANDARDS (ISO 15189:2014)
(GLENMARIE BRANCH) POCKET GUIDE TO THE ACCREDITATION STANDARDS (ISO 15189:2014) Know the requirement!! Prepared by: Dr.Lily Manorammah Contents INTRODUCTION:... 3 OUR STRATEGY... 3 MANAGEMENT REQUIREMENTS...
More informationFSMA Enforcement: The First Year
FSMA Enforcement: The First Year Scott J. MacIntire Director, Division of Enforcement FDA Office of Regulatory Affairs December 6, 2017 Topics to Include Compliance & Enforcement FSMA Inspections Human
More informationOrganization for Economic Co-operation and Development
IGLP document -IRAQ- BAGHDAD English - Or. Arabic Unclassified Organization for Economic Co-operation and Development (2015) 21-Dec-2015 According to criteria of OECD ON TESTING AND CALIBRATION Number
More informationFaster, More Efficient Innovation through Better Evidence on Real-World Safety and Effectiveness
Faster, More Efficient Innovation through Better Evidence on Real-World Safety and Effectiveness April 28, 2015 l The Brookings Institution Authors Mark B. McClellan, Senior Fellow and Director of the
More informationLaTonya M. Mitchell District Director, Denver District Director Office of Regulatory Affairs Office of Global Regulatory Operations & Policy U.S.
LaTonya M. Mitchell District Director, Denver District Director Office of Regulatory Affairs Office of Global Regulatory Operations & Policy U.S. Food and Drug Administration 1 Office of the Commissioner
More informationIntroduction to Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER
Introduction to Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER Sara Camilli, PharmD, BCPS, Safety Evaluator Team Leader Selena Ready, PharmD, CGP, Safety Evaluator Division of Pharmacovigilance
More informationMEETING. of Transfusion Service Information
Second Integration Annual or Pathology Disintegration All Staff MEETING of Transfusion Service Information Suzanne H. Butch, MLS(ASCP) CM, SBB CM, DLM CM University of Michigan Hospitals and Health Centers
More informationInvestigator Roles and Responsibilities in Clinical Device Trials
Investigator Roles and Responsibilities in Clinical Device Trials A Total Product Lifecycle Approach to Medical Device Development: Responsibilities and Opportunities The Stanford Center for Clinical and
More informationOptimizing Medical Device Safety: A Closed Loop Process
Optimizing Medical Device Safety: A Closed Loop Process Session #149, February 22, 2017, 8:30AM Shelly Crisler & Katrina Jacobs US Department of Veterans Affairs 1 Speaker Introduction Shelly Crisler,
More informationMedical 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 informationA. Occupational Safety and Health Act of 1970 (OSH Act of 1970), Section 19, Federal Agency Safety Programs and Responsibilities.
OFFICE OF OCCUPATIONAL SAFETY, HEALTH, TSA MANAGEMENT DIRECTIVE No. 2400.2 OCCUPATIONAL SAFETY, HEALTH AND AND ENVIRONMENT ENVIRONMENT TSA MANAGEMENT DIRECTIVE No. 2400.2 OCCUPATIONAL SAFETY AND HEALTH
More informationWARNING LETTER CERTIFIED MAIL -~ Q December 14, 2005
-~ Q DEPARTMENT Or HEALTI-I A\D HUMAN SERVICES Public Health Service Food and Drug Administration Central Region Telephone (973) 526-6006 New Jersey District Waterview Corporate Center 10 Waterview Blvd.,
More informationStrengthening Patient Care: Building an Effective National Medical Device Surveillance System. February 2015
Strengthening Patient Care: Building an Effective National Medical Device Surveillance System February 2015 The Brookings Institution l Washington, DC www.brookings.edu Authors Gregory Daniel Managing
More informationGood Clinical Practice: A Ground Level View
Good Clinical Practice: A Ground Level View Jeanna Julo, BA, BA, CCRP Assistant Director, Clinical Data Management & Quality Controls, Auditing & Training Clinical Research Administration Research Institute,
More informationFSMA Update. Jennifer Thomas Interim Director for FSMA Operations Center for Food Safety and Applied Nutrition Food and Drug Administration May 2018
FSMA Update Jennifer Thomas Interim Director for FSMA Operations Center for Food Safety and Applied Nutrition Food and Drug Administration May 2018 Foundational Rules Regulation Final Rule Published Preventive
More informationFDA 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 informationMeaningful Use Is a Stepping Stone to Meaningful Care
Meaningful Use Is a Stepping Stone to Meaningful Care Liz Johnson, RN-BC, MS, FCHIME, FHIMSS, CPHIMS Chief Clinical Informaticist and Vice President of Applied Clinical Informatics Tenet Healthcare Corporation
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL GUIDELINES FOR RECALL/ WITHDRAWAL OF MEDICINES This document has been prepared to serve as a recommendation to applicants regarding the recalls of medicines, and the Medicines
More informationIVDD revision changes to the European regulation of in-vitro diagnostic (IVD) Medical Devices. Med-Info. TÜV SÜD Product Service GmbH
Med-Info International expert information for the Medical Device industry IVDD revision changes to the European regulation of in-vitro diagnostic (IVD) Medical Devices The current regulatory framework
More informationMedical Equipment Management. Medical Equipment Management Activities (EC and EC )
Medical Equipment Management Plan 2017 I. Introduction, Mission Statement, and Scope The Medical Equipment Management Plan defines the mechanisms for interaction and oversight of the medical equipment
More informationAn Update on FDA s Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies Proposed Rule
An Update on FDA s Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies Proposed Rule SOT: Regulatory and Safety Evaluation Specialty Section Webinar September 29, 2017 Mark Seaton, Ph.D.,
More informationTraining Update: Preventive Controls Regulator Training
Training Update: Preventive Controls Regulator Training Patricia L. Alcock Director, Office of Training, Education and Development Food and Drug Administration 1/30/2018 9:00 AM Today s Agenda - Preventive
More informationEHR] A INSPECTION REPORT. Guy s Hospital Pharmacy St Thomas Street London SE1 9RT. Safeguarding public health
Safeguarding public health EHR] A INSPECTION REPORT Guy s Hospital Pharmacy St Thomas Street London SE1 9RT Head Office: Inspection & Standards Division, Market Towers, I Nine Elms Lane, Vauxhall, London,
More informationMAIMONIDES MEDICAL CENTER. SUBJECT: Medical Equipment Failures and Medical Device Reporting Program
MAIMONIDES MEDICAL CENTER CODE: AD-101 (Reissued) DATE: May 7, 2013 ORIGINALLY ISSUED: 4/19/1993 SUBJECT: Medical Equipment Failures and Medical Device Reporting Program I POLICY: It is the policy of Maimonides
More informationFDA Inspectional Process in Clinical Research An FDA Perspective. Annette Melendez, MPHsN Investigator Office of Biological Products Operations
FDA Inspectional Process in Clinical Research An FDA Perspective Annette Melendez, MPHsN Investigator Office of Biological Products Operations Outline BIMO PROGRAM OVERVIEW PROGRAM COVERED AREAS INSPECTIONAL
More informationFSMA Update. Samantha Shinbaum. October 3, 2017
FSMA Update Samantha Shinbaum October 3, 2017 Background Information A Little About Me Received my Bachelors from the University of Florida. Received my Masters from the University of Arkansas. Working
More informationDRAFT 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 informationRadiopharmaceutical. Qualification. Checklist
Radiopharmaceutical Vendor Qualification Checklist section 1: RegulatoRy compliance Overview Nuclear pharmacies play an essential role in the preparation and distribution of radiopharmaceuticals for use
More informationBest Practices for Equipment Calibration and Analytical Controls in the Diagnostics Laboratory
Best Practices for Equipment Calibration and Analytical Controls in the Diagnostics Laboratory George Rodrigues, Artel (slides 2-16) Rebecca Butler, CareDx (slides 17-29) Agenda Agenda Theory / Regulations
More informationMeaningful Use Stage 2 For Eligible and Critical Access Hospitals
Meaningful Use Stage 2 For Eligible and Critical Access Hospitals Eileen Colen This material was prepared by HealthInsight, the Medicare Quality Improvement Organization for Nevada and Utah, under contract
More informationMobile Positron Emission Tomography
Mobile Positron Emission Tomography PURPOSE This procedure provides general instructions for developing, maintaining, and documenting radiation protection procedures for preparation, calibration and administration
More informationUniversity of Colorado Denver Human Research Protection Program Investigator Responsibilities for the Protection of Human Subjects
Institutional Guidelines The Colorado Multiple Institutional Review Board (COMIRB) recently reviewed and approved your research. The COMIRB reviews research to ensure that the federal regulations for protecting
More informationThe Mammography Quality Standards Act Final Regulations Motion of Tube-Image Receptor Assembly
Compliance Guidance The Mammography Quality Standards Act Final Regulations Motion of Tube-Image Receptor Assembly Document issued on March 23, 1999 U.S. Department Of Health And Human Services Food and
More informationCase: 1:10-cv Document #: 74-1 Filed: 04/15/11 Page 1 of 7 PageID #:2403 EXHIBIT A
Case: 1:10-cv-06016 Document #: 74-1 Filed: 04/15/11 Page 1 of 7 PageID #:2403 EXHIBIT A Case: 1:10-cv-06016 Document #: 74-1 Filed: 04/15/11 Page 2 of 7 PageID #:2404 UNITED STATES DISTRICT COURT NORTHERN
More informationBIMO SITE AUDIT CHECKLIST
Item AUTHORITY AND ADMINISTRATION FOR STUDIES INVOLVING HUMAN DRUGS, BIOLOGICS AND DEVICES 1. Compare the Investigator Agreement with the information provided by the assigning Center. Auditor will check
More informationThe 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 informationReview of Existing Center for Drug Evaluation and Research Regulatory and Information
This document is scheduled to be published in the Federal Register on 09/08/2017 and available online at https://federalregister.gov/d/2017-19033, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
More information1 What is an AAAHC/Medicare Deemed Status survey? 2 What are the Medicare Conditions for Coverage (CfC)?
FREQUENTLY ASKED QUESTIONS ABOUT MEDICARE DEEMED STATUS SURVEYS 1 What is an AAAHC/Medicare Deemed Status survey? The Centers for Medicare and Medicaid Services (CMS) accepts AAAHC s recommendation for
More information