CDRH Premarket Approval Application Critical to Quality Pilot Program

Ajit Basrur

Staff member
Admin
#1
The Food and Drug Administration's (FDA or Agency or we) Center for Devices and Radiological Health (CDRH or Center), Office of Compliance (OC) and Office of In Vitro Diagnostics and Radiological Health (OIR) is announcing its Premarket Approval Application Critical to Quality (PMA CtQ) pilot program. Participation in the PMA CtQ pilot program is voluntary and the program aims to evaluate device design and manufacturing process quality information early on to assist FDA in its review of the PMA manufacturing section and post-approval inspections.

This voluntary pilot program is part of the FDA's ongoing Case for Quality effort to apply innovative strategies that promote medical device quality and is a joint effort between the FDA's CDRH and Office of Regulatory Affairs (ORA). The pilot program is intended to provide qualifying PMA applicants with the option to engage FDA on development of CtQ controls for their device and forego the standard PMA preapproval inspection. FDA would in turn, focus on the PMA applicant's implementation of the CtQ controls during a postmarket inspection.

Read here: Center for Devices and Radiological Health Premarket Approval Application Critical to Quality Pilot Program
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
S FDA CDRH Premarket Review Submission Cover Sheet - adding more products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R FDA CDRH Premarket Review Requirements - Submission Cover Sheet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D CDRH Premarket Review Submission Cover Sheet Form 3514 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
M Informational US FDA – CDRH Proposed Guidances for Fiscal Year 2020 (FY 2020) Medical Device and FDA Regulations and Standards News 0
M Informational US FDA CDRH’s Health of Women Program Strategic Plan Medical Device and FDA Regulations and Standards News 0
M Informational CDRH’s Regulatory Science Priorities Medical Device and FDA Regulations and Standards News 3
Ronen E FDA News FDA's CDRH is silo-ing along product lines - CDRH Reorganization Medical Device and FDA Regulations and Standards News 4
M Informational CDRH Proposes New IMDRF Work Item on Standards Medical Device and FDA Regulations and Standards News 0
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
O FDA- CDRH - Design considerations for devices intended for home use US Food and Drug Administration (FDA) 1
M Medical Device News FDA News - 03-10-18 - CDRH FY 2019 Proposed Guidance Development and Focused Retrospective Review of Final Guidance Other US Medical Device Regulations 0
M Medical Device News FDA News - 24-09-18 - CDRH Releases Collaborative Communities Toolkit Other US Medical Device Regulations 0
JoshuaFroud CDRH Annual Report - eSubmitter Other US Medical Device Regulations 0
Ajit Basrur CDRH Customer Satisfaction Results at 87% US Food and Drug Administration (FDA) 1
Ajit Basrur CDRH 2014 Strategic Priorities US Food and Drug Administration (FDA) 2
S CDRH Appeals Process - New FDA Guidance Document Other US Medical Device Regulations 1
L Regarding CDRH Cover Sheet and prior related Submissions Other Medical Device and Orthopedic Related Topics 3
Ronen E CDRH Export Certification and Tracking System launched Other US Medical Device Regulations 0
Ajit Basrur FDA - CDRH Fiscal Year 2013 (FY 2013) Proposed Guidance Development US Food and Drug Administration (FDA) 0
Ajit Basrur Strategic priorities for FDA's CDRH - 2012 US Food and Drug Administration (FDA) 1
G FDA's CDRH report "Barriers on Medical Device Quality" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
W "Application Correspondent" in the CDRH Review Cover Sheet - What does mean? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Kit Certification for 510(k)s on the CDRH website - Does anyone make these? Other US Medical Device Regulations 1
A CDRH Guidance Document - Software bugs submitted in 510(k): Quantity or Quality? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T To IDE or not to? FDA/CDRH website/guidance documents too hard to understand ISO 13485:2016 - Medical Device Quality Management Systems 2
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
S PMS (Premarket Submission) and PMCF Plan EU Medical Device Regulations 5
P 21 CFR 807.81 When a premarket notification submission is required Other US Medical Device Regulations 0
M Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classificati Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final guidance – Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions Medical Device and FDA Regulations and Standards News 0
Ronen E FDA News FDA issues guidance on bench testing in premarket submissions Other US Medical Device Regulations 0
M Informational USFDA draft guidance – Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Guidance – Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Guidance – Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA draft guidance – Principles of Premarket Pathways for Combination Products; Draft Guidance for Industry; Availability Medical Device and FDA Regulations and Standards News 0
S Is Software code documentation required for FDA premarket submissions? IEC 62304 - Medical Device Software Life Cycle Processes 2
S IDE to support premarket submissions Other US Medical Device Regulations 0
S Clinical Studies - Premarket Submission Requirements Canada Medical Device Regulations 1
M Medical Device News FDA Releases Draft Recommendations on Premarket Submissions for Management of Cybersecurity in Medical Devices Other US Medical Device Regulations 0
M Medical Device News IMDRF update - 26-09-18 - Cybersecurity, Premarket Reviews, Personalized Devices Other Medical Device Regulations World-Wide 0
M Medical Device News FDA news 14-09-18 - Use of Voluntary Consensus Standards in Premarket Submissions Other US Medical Device Regulations 3
M Medical Device News FDA news -11-09-18 - Review of Cybersecurity into Premarket Review Other US Medical Device Regulations 0
K FDA Premarket Submissions for Embedded Software - Level of Concern Other US Medical Device Regulations 4
B Looking for a Premarket Approval (PMA) Template or checklist Other US Medical Device Regulations 4
K 510k "Premarket" Submission for Existing Class II Software Medical Device US Food and Drug Administration (FDA) 3
somashekar FINAL ORDER: Premarket Approval for AED Systems: Other US Medical Device Regulations 0
P FDA - Evaluating Substantial Equivalence in Premarket Notifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom