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 Update Questions and Answers FDA News Quality 2 Con
Themes for 2015 Three familiar themes for device quality continue this year The device industry is not getting any simpler Money/budget for regulatory changes continue to be limited Expectations for regulatory change continue to be high FDA News Quality Congress - CDRH Update 3
PROGRAM ALIGNMENT FDA News Quality Congress - CDRH Update 4
Why: Program Alignment Increased complexity in FDA s mandate Impact of globalization on the supply chain Trend towards innovation What A plan to transition to a commodity-based program integrated with each of the product centers. 1 1: http://blogs.fda.gov/fdavoice/index.php/2014/10/fdas-program-alignment-addressesnew-regulatory-challenges/ FDA News Quality Congress - CDRH Update 5
Program Alignment FDA News Quality Congress - CDRH Update 6
Program Alignment Regarding the timeline: Some foundational tasks are due before 10/2015 Longer term tasks are due in the next two fiscal years. Even in this early stage, CDRH and ORA talking about the benefits of aligning along product lines FDA News Quality Congress - CDRH Update 7
FDA S CASE FOR QUALITY UPDATE FDA News Quality Congress - CDRH Update 8
Current approach reinforces compliance not necessarily quality 1 Case for Quality 2 activities Projects that encourage operating above the regulatory baseline A forum for engaging on the device quality arena 1: http://www.fda.gov/medicaldevices/deviceregulationandguidance/medicaldevicequalityandcompliance/ucm378185.htm 2: http://www.fda.gov/medicaldevices/deviceregulationandguidance/medicaldevicequalityandcompliance/ucm378185.htm FDA News Quality 9 Con
Ongoing activities Stakeholder Forum Critical to Quality (CtQ) Implantable Devices/Battery Pilot DMQ CtQ Info Documents PMA CtQ Confirmation Pilot Library of Quality Practices Data Transparency Quality Measures FDA News Quality Congress - CDRH Update 10
Stakeholder Forum MDIC will convene this forum 1 Researching use of Quality Maturity Models Regular meetings to discuss: Areas for improving quality Chartering new approaches Updates on projects Some meetings targeted, some broad in scope 1: http://mdic.org/case-for-quality-cfq/ FDA News Quality Congress - CDRH Update 11
Critical to Quality (CtQ) Started as an inspection pilot CtQs generated via: Internal CDRH and ORA experts Technical stakeholder input CtQs written into inspectional guidance Shared with investigators Shared with firms being inspected 4 inspections completed FDA News Quality Congress - CDRH Update 12
Critical to Quality (CtQ) DMQ 2014 efforts PMA CtQ Info. Doc. Division Pilot 1 Tech. Stakeholder CtQ Info. Doc. RBWP CtQ Info. Doc. ASD Branch 4 1 CD Branch 2 POND Branch 1 1 REGO Branch 1 Total CtQ Information Documents: FDA CtQ Pilot: 1 DMQ division: 12 Total: 13 FDA News Quality Congress - CDRH Update 13
Critical to Quality (CtQ) current format Key characteristic Impact of failure Sphericity and surface finish of the endplates are two key characteristics, because nonconformity of either one of these key characteristics can lead to excessive wear, which can ultimately lead to pain, metal debris inside the end-user s body, and need for revision surgery. Control A. Sphericity is primarily an output of the CNC Turning, CNC Milling, and Deburring processes and verified through the Dimensional Inspection Process [21 CFR 820.80] [QSIT P&PC Objective #2] Reference to 820 Reference to QSIT FDA News Quality Congress - CDRH Update 14
(new) PMA CtQ Confirmation Pilot For those PMA manufacturing sections with no deficiencies in the original submission Applicant inspected within the last five years For applicants willing to participate Applicant submits CtQs. FDA reviews. Preapproval confirmation of controls. Postapproval QSIT FDA News Quality Congress - CDRH Update 15
(new) FDA Library of Quality Practices A resource that promotes building the knowledge-base on device quality. Working with other organizations but also making our own internal training material more readily available Look for more on this concept as we develop it throughout 2015. FDA News Quality Congress - CDRH Update 16
Quality Measures Interested in indicators of product quality Identifying measures tied to best practices Preproduction, production and postproduction Workgroup comprised of industry and agency personnel Expecting compilation of measures by mid-year and discussion at MDIC. FDA News Quality Congress - CDRH Update 17
Data Transparency Stakeholder needs assessment Informed Inspections Application Programming Interface (API) 3 rd party data analysis FDA News Quality Congress - CDRH Update 18
Look for further opportunities to interact on device quality with FDA In the meantime, consider asking: What does the term quality mean to me? How do we use this term at our company? Are our company s current high-priority projects focused on quality system execution? Are they focused on ensuring overall device quality? FDA News Quality 19 Con
Contact Information Bill MacFarland Director, Division of Manufacturing and Quality FDA, Center for Devices and Radiological Health Office of Compliance Division of Manufacturing and Quality Building WHITE OAK #66, Rm 3680 10903 New Hampshire Avenue Silver Spring, MD 20993 Tel: 301-796-5547 Email: william.macfarland@fda.hhs.gov FDA News Quality Congress - CDRH Update 20