The FDA's latest proposed LDT (Laboratory Developed Tests) rule-making has sparked an unprecedented level of public engagement. The volume of comments submitted has been overwhelming, possibly more than any other recent policies by the Department of Health and Human Services.
Since the public comment period closed on December 4th, the regulations.gov system has faced challenges in publishing these comments. Moreover, with over 6,707 comments eventually published, the system is currently able to display only 500. For those interested in diving deeper, like myself, you can perform following:
- Visit the Comment Page: Go to FDA-2023-N-2177 Comments.
- Keyword Search for Specific Comments: To find specific comments, use the search bar for keywords. For example, type in "new york" to filter relevant comments.
- Use the Bulk Data Download Tool: 1. Go to Regulations.gov Bulk Download. 2. In the 'Docket ID' field, enter 'FDA-2023-N-2177'. 3. Select 'Public Submission' as the Document Type. 4. Choose a 'Posted Start Date' before November 2023. 5. Submit your request.
- Receive and Review the Data: After submitting, you'll receive a CSV file via email. This file contains all available comments, including direct links to the files with each comment.
- Now I hope you've got Excel on turbo mode and a screen big as TV. ??????
Experienced Laboratory Director in Molecular Genetic Pathology and Chemistry
1 年The FDA cannot answer 6 thousand public comments yet expects to regulate 6 thousand LDTs. Would be better if the FDA would put the same effort to work together with CMS/CLIA to provide input rather than dig in on its own.
Senior Director of Regulatory Affairs at Natera Inc. | Former FDA reviewer | CDx/Dx | Global Regulatory puzzle solver
1 年This is where ChatGPT can be quite useful to make sense of the comments
Principal at Bruce Quinn Associates LLC
1 年This is great! I posted a link to your article on my blog. I also posted a cloud copy of the Excel FDA docket. https://www.discoveriesinhealthpolicy.com/2024/01/bulk-download-of-fed-reg-comments-tips.html