FDA Guidance Document for Preparing Annual Product Reviews

  • Thread starter DeborahBartlett63
  • Start date
D

DeborahBartlett63

#1
I have seen several documents about what should be included in an Annual Product Review (APR); however, I am looking for the FDA Guidance document for the preparation of an APR. I know the requirement is in 211.180e, but as we all know it is very vague.

I would appreciate any help find this or other documents that could help with the preparation of APRs.

Thank you!!
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
S Sterilization Site Move - Dec 2018 FDA Guidance Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ajit Basrur FDA News FDA Guidance Document: Manufacturing Site Change Supplement US Food and Drug Administration (FDA) 0
R New Draft Guidance Document for FDA's current thinking on De Novo submission Other US Medical Device Regulations 1
Ajit Basrur FDA issues Guidance Document - Benefits-Risks Factors to consider for 510(K) US Food and Drug Administration (FDA) 1
E FDA Significant Change Interpretation - Guidance Document EU Medical Device Regulations 2
Ajit Basrur FDA Guidance Document - Expedited Programs for Serious Conditions ? Drugs & Biologics Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
S CDRH Appeals Process - New FDA Guidance Document Other US Medical Device Regulations 1
Ajit Basrur FDA Guidance Document - User Fees for 513(g) Requests US Food and Drug Administration (FDA) 3
Gert Sorensen FDA Voluntary Audit Report Submission Pilot Program now a final guidance document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S New FDA Guidance document released for Promotional Material, Labeling, etc Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
P Software Changes - Is an FDA guidance type of document available from SFDA (China)? China Medical Device Regulations 2
bio_subbu FDA Issues Guidance Document on Electrocardiograph (ECG) Electrodes Other US Medical Device Regulations 0
bio_subbu FDA issues first draft guidance document on Mobile Medical Applications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
Y Applying Human Factors and Usability Engineering - FDA Guidance Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Guidance Document or Regulation Reference for Scanned Signatures (FDA/EMEA) US Food and Drug Administration (FDA) 4
P Level of Concern anomaly - FDA Guidance Document Conflicts 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
bio_subbu FDA Guidance document - User Fees and Refunds for 510(k) submissions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R EC11 - Guidance Document - FDA 510 (k) Submission - ECG Monitors 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
A New format for 510(k)'s - Guidance document from the FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 6
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Clinical Decision Support Software Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0
M Informational FDA draft guidance – Safer Technologies Program for Medical Devices Medical Device and FDA Regulations and Standards News 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 – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1
M Informational US FDA Final Guidance – Humanitarian Device Exemption (HDE) Program 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 draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final guidance – Postmarketing Safety Reporting for Combination Products 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 US FDA final guidance – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Medical Device and FDA Regulations and Standards News 0
M Informational US FDA draft guidance. – Clinical Investigations for Prostate Tissue Ablation Devices Medical Device and FDA Regulations and Standards News 2
M Informational US FDA draft guidance – Mouse Embryo Assay for Assisted Reproduction Technology Devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA final guidance – Utilizing Animal Studies to Evaluate Organ Preservation Devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA final guidance Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices 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 FDA Guidance - general wellness products - wearables Other Medical Device Related Standards 3
Ed Panek Website to ask FDA for guidance in Medical Device Industry? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Informational USFDA draft guidance – Nonbinding Feedback After Certain FDA Inspections of Device Establishments Medical Device and FDA Regulations and Standards News 0
D FDA filing guidance to add sterilization step for approved drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8

Similar threads

Top Bottom