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CAC
FDA Final Rule
| MSACL-CAC Disclaimer: The information provided in the downloadable documents below is for general informational purposes only and should NOT be considered legal advice. Regulatory rules and compliance requirements can vary significantly depending on specific circumstances. It is essential to consult with a qualified attorney or regulatory professional who is familiar with your specific circumstances and can provide guidance tailored to your situation before taking any actions based on the content presented herein. |
Phase 1 Compliance Documents
These are draft template documents available for download, to assist with laboratory compliance as required in Phase 1 of the FDA's Final Rule.
- LC-MSMS Complaints SOP Template
- Batch Cover Sheet Example Template
- Complaints Log File Template
- Complaints Recording Form Template
- Nonconforming Events Report Form Template
- Nonconforming Events SOP Template
Helpful Links
FDA
- Federal Register
- Part 803- Medical Device Reporting
- Part 806- Reports of Corrections and Removals
- 820.198- Complaint Files
- FDA Guidance Document: Medical Device Reporting for Manufacturers
- FDA Guidance Document: Electronic Medical Device Reporting
- FDA Guidance Document: Recalls, Corrections and Removals (Devices)
- FDA Complaint Files Summary Slides
- FDA Nonconforming Product Summary Slides
CLSI
Helpful Webinars
MSACL
ADLM
- ADLM 2024/06/02 The U.S. FDA's Rule on LDTs - What it Means for You
- ADLM 2024/09/25 Complying with the FDA's Rule on LDTs: What You Need to do and When
CAP
CLSI
FDA
- FDA 2024/05/14 Final Rule: Medical Devices; LDTs
- FDA 2024/09/24 Labeling Requirements for IVD Products, including LDTs, Under 21 CFR 809.10(b)
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