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.
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Key Dates
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