FDA Requests Input on Medical Device Accreditation Plan
Published Date: 7/17/2026
Notice
Summary
The FDA wants your thoughts on a plan to improve how they check if medical products meet safety rules. This affects companies making medical devices and could change how they prove their products are safe. You’ve got until September 15, 2026, to share your ideas—no cost changes yet, just a chance to help shape the process!
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
FDA Accepts ASCA Lab Findings
If you make medical devices, results from ASCA-accredited testing laboratories will be accepted by FDA to show your product meets an eligible standard. You can include a declaration of conformity and a summary test report in a premarket submission, and FDA generally will not review the complete test reports from ASCA-accredited labs except in certain circumstances.
FDA Can Audit and Withdraw Accreditation
FDA may review determinations by accredited testing laboratories, conduct periodic audits, and, after review or if FDA learns information materially bearing on safety or effectiveness, take actions such as suspending or withdrawing a laboratory's accreditation or requesting additional information about a specific device.
Estimated Burden Hours and Net Decrease
FDA estimates annual ASCA-related burdens of 949 hours for reporting activities, 733 hours for recordkeeping, and 7,995 hours for third-party disclosures, and reports an overall net decrease of approximately 685 burden hours as the program moved from pilot to permanent. These estimates reflect fewer expected initial applications and reduced average burden per response for certain activities.
Participation Requires Applications and Training
Accreditation bodies and testing laboratories must apply to FDA to participate in the ASCA Program and agree to terms of participation, including attending training, regularly communicating with FDA, and supporting periodic FDA audits. FDA will recognize qualified applicants and identify the scope of recognition for specific standards and test methods.
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
2026-14073 — Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047 — Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-14438 — Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
The FDA wants your thoughts on how they collect info about infant formula rules, like labeling, quality checks, and recordkeeping. This affects infant formula makers who must follow these rules and use a new electronic form to report info. You’ve got until September 15, 2026, to share your comments—no cost changes yet, just a chance to improve how info is gathered!
2026-14434 — Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Cosmetic Products
The FDA wants your thoughts on new info they might collect about cosmetic products. This affects companies making or selling cosmetics, who may need to share more details soon. You’ve got until September 15, 2026, to send in your comments—no cost yet, just your voice!
2026-14436 — Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Program
The FDA wants your thoughts on a new plan to collect info from medical device makers who join a Voluntary Improvement Program. This program aims to help companies improve their devices without extra paperwork stress. If you’re involved in making or managing medical devices, you’ve got until September 15, 2026, to share your feedback—no fees, just your voice!
2026-14283 — Process for FDA Data Requests To Inform Certain Over-the-Counter Monograph Drug Activities; Procedure
The FDA is rolling out a clear process to ask the public for data to help update rules about over-the-counter (OTC) drugs. This means anyone interested in OTC drug safety and use can share info that might change how these medicines are regulated. The new process starts now and aims to make drug updates smarter and faster, with no direct costs to the public but big benefits for safer medicines.
Previous / Next Documents
Previous: 2026-14440 — Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun))
The FDA wants your thoughts on how it collects info about problems with medical devices through its MedSun program. This affects hospitals, device makers, and anyone who reports device issues. Comments are open until September 15, 2026, and the FDA aims to keep the process smooth without extra costs or delays.
Next: 2026-14442 — National Emergency Medical Services Advisory Council
The Department of Transportation is looking for a new State/Local 911 Official to join the National Emergency Medical Services Advisory Council (NEMSAC). This council helps shape how emergency medical services work across the country by giving advice to top transportation leaders. If you want to nominate someone, get those nominations in by August 17, 2026—this role lasts two years and meetings are mostly online, so it’s easy to join in!