FDA Pushes Paperwork for Lab Standards Review
Published Date: 11/24/2025
Notice
Summary
The FDA is asking for public feedback on how it collects info about lab tests to keep them safe and reliable. This affects labs that test human samples and helps decide how tricky each test is. Comments are open until December 24, 2025, with no new costs expected—just smoother rules!
Analyzed Economic Effects
4 provisions identified: 0 benefits, 4 costs, 0 mixed.
Large reporting burden for CLIA waiver applications
If you submit a CLIA waiver application, FDA estimates each submission carries an average burden of 1,200 hours; FDA expects 20 submissions for a total of 24,000 hours and $540,000 in operating and maintenance costs. The guidance lists specific documentation and study results that manufacturers should include in waiver applications.
Extensive recordkeeping for CLIA waivers
For CLIA waiver recordkeeping, FDA estimates 20 recordkeepers with an average burden of 2,800 hours per recordkeeper, totaling 56,000 hours. FDA lists this recordkeeping burden as part of implementing CLIA waiver guidance.
Overall paperwork burden and cost increase
FDA estimates the total burden for this information collection is 80,430 hours (24,430 reporting + 56,000 recordkeeping) and reports an overall increase of 28,030 hours and a corresponding increase of $190,150 in operating and maintenance costs. The OMB control number is 0910-0607 and FDA sought comments by December 24, 2025.
Small time cost for CLIA categorization requests
If you request CLIA categorization from FDA, the agency estimates 430 total responses with an average burden of 1 hour per response (total 430 hours) and $2,150 in operating and maintenance costs. FDA reports 86 respondents making 5 requests each on average.
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