A few days ago, the FDA released a typescript version of its Lab Developed Tests final rule. Now, on May 6, 2024, FDA has released the final typeset Federal Register version (89 FR 37286, 160pp).
Find the web page here:
Find the Fed Reg locked (unmarkable) version here:
https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08935.pdf
SPECIAL FOR READERS: UNLOCKED COPY
The Fed Reg version is locked, meaning you can't mark it up.
Here is an unlocked version so you can highlight and comment:
https://drive.google.com/file/d/1ZHsUP00Bjov40XALG2cVUV2MWtjvOGt6/view?usp=sharing
AI CORNER
Chat GPT was able to make a paginated table of contents, although the first try, it didn't get it correct.
ChatGPT
Thank you for your patience. Here is the updated and accurate paginated index for each section of the document, both in Federal Register and PDF page numbers:
Table of Contents (Federal Register Page Numbers)
Executive Summary - Starts on page 37286
Table of Abbreviations/Commonly Used Acronyms in This Document - Page 37287
Background
A. FDA’s Current Regulatory Framework - Page 37288
B. Need for the Rule - Page 37289
C. Summary of Comments on the Notice of Proposed Rulemaking - Page 37290
D. General Overview of the Final Amendment to the Definition of In Vitro Diagnostic Products - Page 37291
Legal Authority - Page 37292
Phaseout Policy
A. Scope - Page 37293
B. Enforcement Discretion Policies - Page 37294
C. Stages - Page 37295
Comments on the Notice of Proposed Rulemaking and FDA Responses - Page 37296
Effective Date - Page 37433
Economic Analysis of Impacts - Page 37434
Analysis of Environmental Impact - Page 37435
Paperwork Reduction Act of 1995 - Page 37436
Federalism - Page 37436
Consultation and Coordination With Indian Tribal Governments - Page 37437
References - Page 37438
Table of Contents (PDF Page Numbers)
Executive Summary - PDF Page 1
Table of Abbreviations/Commonly Used Acronyms in This Document - PDF Page 2
Background
A. FDA’s Current Regulatory Framework - PDF Page 3
B. Need for the Rule - PDF Page 4
C. Summary of Comments on the Notice of Proposed Rulemaking - PDF Page 5
D. General Overview of the Final Amendment to the Definition of In Vitro Diagnostic Products - PDF Page 6
Legal Authority - PDF Page 7
Phaseout Policy
A. Scope - PDF Page 8
B. Enforcement Discretion Policies - PDF Page 9
C. Stages - PDF Page 10
Comments on the Notice of Proposed Rulemaking and FDA Responses - PDF Page 11
Effective Date - PDF Page 148
Economic Analysis of Impacts - PDF Page 149
Analysis of Environmental Impact - PDF Page 150
Paperwork Reduction Act of 1995 - PDF Page 151
Federalism - PDF Page 151
Consultation and Coordination With Indian Tribal Governments - PDF Page 152
References - PDF Page 153
This detailed index should now correctly align the sections with their respective starting pages in both the Federal Register and PDF formats. If you need further adjustments or additional details, feel free to ask!