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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. |
Updates
ACLA's and AMP's Suits over the LDT Final Rule: Summary Judgement Promised "Soon"
Christine P. Bump | Feb 20, 2025
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 Literature
- Regulatory requirements for laboratory developed tests in the United States
- IVDR and diagnostic application of mass spectrometry in the European Union
- Partial Postponement of the Application of the In Vitro Diagnostic Medical Devices Regulation in the European Union
Helpful Tools
- Quick Links to obtain an FEI number and Other ID Tasks
- Suggestions for an Action Items Short List on 05/06/25 FDA Phase 1 LDT Final Rule Compliance
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
- READ ME for 2025 Feb 19 MSACL-CAC webinar on LDT Materials Tracking
- MSACL 2024/10/29 LDT & the FDA - Will You be Ready? First Steps for 6 May 2025 Compliance at LC-MSMS CLIA Laboratories
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)
MediaLab
Upcoming Webinars
- 2025 March 20 : CAP : Part four of a six-part CAP series on understanding and preparing for the impact of the FDA’s LDT final rule : Ready Your Laboratory for the FDA’s Stage 1: Rules for Quality System Complaint Processes
- CAP series of 6 LDT Final Rule webinars in 2024/2025 (Upcoming and On Demand)
- 2025 March 27 : MSACL Connect : Up or Under: Will Labs Rise or Be Buried by FDA’s LDT Rule?
- American Society of Transplantation: The Impact of the New FDA Final Rule on Laboratory Developed Tests (LDT) in Transplantation
Litigation Updates
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