Radiation Gadgets' Paper Trail: FDA Update Call
Published Date: 2/18/2026
Notice
Summary
The FDA is updating its paperwork rules for electronic products that emit radiation to keep everyone safe. If you make or sell these products, you might need to provide some info to the government. Comments on these changes are open until March 20, 2026, so now’s the time to speak up!
Analyzed Economic Effects
2 provisions identified: 0 benefits, 2 costs, 0 mixed.
Big Paperwork Burden for Product Makers
If you make, import, assemble, or sell electronic products that emit radiation, you must submit many reports and keep records under 21 CFR parts 1000–1050 using FDA forms (for example, FDA Forms 2579, 2767, 2877, 3628–3663, 3649). FDA estimates annual reporting totals of 981,203 responses requiring 341,676 hours, recordkeeping totaling 3,663,021 records requiring 429,188 hours, and third-party disclosures totaling 42,129 disclosures requiring 15,559 hours.
New Consumer ARO Form Raised Burden Significantly
FDA added a new form (Form FDA 3649C, Consumer Accidental Radiation Occurrence Report) and adjusted respondent counts, which FDA says increased this information-collection burden by 381,821 hours and by 2,135,962 additional responses/records in the overall estimate.
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