FDA Seeks Input on Medical Device Approval Paperwork Burden
Published Date: 4/10/2026
Notice
Summary
The FDA wants your thoughts on how they collect info for approving new medical devices before they hit the market. This affects device makers who must provide detailed info to get approval, and the FDA is asking for comments by June 9, 2026. No big cost changes yet, but your feedback could shape how easy or tricky the approval process is in the future!
Analyzed Economic Effects
5 provisions identified: 1 benefits, 4 costs, 0 mixed.
Big Increase in PMA Paperwork Hours
If you submit or hold premarket approval (PMA) for medical devices, the FDA estimates the annual reporting burden for this collection at 1,182,316 hours and the annual recordkeeping burden at 29,240 hours. FDA says its overall burden estimate rose about 244% for reporting and 212% for recordkeeping compared with prior estimates.
Ongoing Recordkeeping Requirement for PMA Holders
If you hold an approved PMA, you must maintain records required by 21 CFR 814.82(a)(5) and (a)(6). FDA estimates 860 recordkeepers will keep 1,720 records (2 per recordkeeper) at about 17 hours per record, for a total of 29,240 hours annually.
Pediatric-Use Information Must Be Submitted
PMA applicants must include pediatric-use information under section 515A of the FD&C Act. FDA estimates 3,954 annual pediatric-related submissions at about 2.10 hours each, totaling 8,303 hours per year for these items.
Clinical Trial Certification Requirement (Form FDA 3674)
PMA applications must be accompanied by a certification (Form FDA 3674) under 42 CFR part 11 when applicable, including National Clinical Trial numbers where available. FDA estimates 61 such certifications at 0.75 hours each for a total of 46 hours annually.
eSTAR Electronic Submissions Could Lower Burden
FDA encourages use of eSTAR (electronic Submission Template and Resource) and estimates initial eSTAR setup activity at 9,174 responses with 0.08 hours each (total 734 hours). FDA states eSTAR should significantly reduce submission burden by standardizing formats.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-09767 — Oscar Bobo: Final Debarment Order
Oscar Bobo is officially banned for 5 years from importing any drugs into the U.S. because he repeatedly brought in mislabeled medicines that don’t follow FDA rules. He didn’t respond to the FDA’s warning, so the ban started on May 15, 2026. If he wants to end the ban early, he can apply anytime, but must follow special rules to keep his info private.
2026-09533 — Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information
The FDA wants your help to improve tests that spot kidney damage caused by medicines. They’re asking researchers, doctors, and companies to share data by July 13, 2026, so they can make these kidney safety markers better and faster. This could lead to safer drugs and smarter health checks, benefiting patients and the medical community alike.
2026-09508 — Azodicarbonamide (ADA); Request for Information
The FDA is asking for info about azodicarbonamide (ADA), a chemical used in some foods and food packaging, to check if it’s still safe. Food makers, scientists, and anyone with data should share what they know by July 13, 2026. This review could lead to changes in how ADA is used, affecting food companies and possibly costs down the line.
2026-09543 — Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting
The FDA wants your thoughts on how drug companies report problems after their products hit the market. This update affects drug makers and helps keep medicine safe by improving how side effects are tracked. You’ve got until July 13, 2026, to share your comments—no cost to join, just your voice!
2026-09544 — Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc.
The FDA is inviting the public to comment on the renewal of special approval for two cigarette products by 22nd Century Group Inc. These products claim to lower health risks compared to regular cigarettes. If renewed, the company can keep marketing them this way, with the comment period starting May 13, 2026.
2026-09507 — Butylated Hydroxytoluene (BHT); Request for Information
The FDA wants to know more about how butylated hydroxytoluene (BHT), a chemical used in food and food packaging, is being used and if it’s still safe. They’re asking companies, scientists, and the public to share any info by July 13, 2026. This could lead to changes in rules that affect food makers and might impact what’s allowed in your snacks and packaging.
Previous / Next Documents
Previous: 2026-06905 — Clean Air Act Operating Permit Program; Order on Petition for Objection To State Operating Permit for Caerus Piceance, LLC-Hunter Mesa Water Treatment Facility
The EPA said no to a request from an environmental group to block a pollution permit for Caerus Piceance’s Hunter Mesa water treatment plant in Colorado. This means the plant can keep operating under its current permit, with no new costs or delays. If anyone wants to challenge this decision, they have until June 9, 2026, to take it to court.
Next: 2026-06910 — Clean Air Act Operating Permit Program; Order on Petition for Objection to State Operating Permits for Bonanza Creek Energy Operating Company, LLC-Antelope CPF 13-21 Production Facility, State Antelope O-1 Central Production Facility, State North Platte 42-26 Central Production Facility and State Pronghorn 41-32 Central Production Facility
The EPA has decided not to block the air pollution permits for four Bonanza Creek Energy facilities in Colorado after a challenge from an environmental group. This means the company can keep operating under the current rules, but anyone unhappy with this decision has until June 9, 2026, to ask a court to review it. No new costs or changes to operations are required right now.