FDA Seeks Comments on Its Medical Device Testing Program
Published Date: 10/23/2026
Notice
Summary
The FDA is asking for public feedback on continuing its Accreditation Scheme for Conformity Assessment (ASCA) program, which helps testing labs prove medical devices meet safety standards. This program affects testing labs and device makers by streamlining device approvals and ensuring safety. Comments are due by November 23, 2026, and the program helps keep medical devices safe without adding extra costs.
Analyzed Economic Effects
5 provisions identified: 3 benefits, 2 costs, 0 mixed.
FDA Will Generally Accept ASCA Lab Results
If you make or sell medical devices, FDA will generally accept determinations from ASCA-accredited testing laboratories that a device conforms with an eligible standard. Testing done by an ASCA-accredited laboratory can be used to support a premarket submission when the testing uses a standard eligible for inclusion in the ASCA Program and follows ASCA program specifications.
Estimated Reporting Burden and Time Costs
The notice reports estimated annual reporting activities totaling 795 respondents in Table 1, recordkeeping for 181 recordkeepers and 733 hours in Table 2, and third-party disclosure activity with 1,206 annual disclosures and 7,995 hours in Table 3. Specific line items include 50 testing laboratories applying for ASCA Accreditation (200 hours total) and 880 test reports (880 hours) as listed in the tables.
Net Reduction of About 829 Burden Hours
FDA adjusted its burden estimate and reports an overall net decrease of approximately 829 burden hours. The decrease includes 48 hours from removing initial applications for ASCA Recognition; 400 hours from reducing anticipated ASCA Accreditation applications from 150 to 50 respondents; 225 hours from reducing testing laboratory continuation requests time from 4 to 1 hour; and other listed reductions.
FDA May Audit and Withdraw ASCA Accreditations
FDA may review determinations by accredited testing laboratories and conduct periodic audits of those determinations or of accreditation bodies and testing laboratories. Following a review or if FDA learns of information materially bearing on safety or effectiveness, FDA may suspend or withdraw a testing laboratory's ASCA Accreditation, withdraw an accreditation body's ASCA Recognition, or request additional information about a specific device.
ASCA Aims to Support Patient Access to Safe Devices
FDA states the ASCA Program supports using scientific resources efficiently to protect public health and may encourage international harmonization of medical device regulation. FDA says the ASCA Program helps ensure that patients and healthcare providers have timely and continued access to safe, effective, and high-quality medical devices.
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