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on the science and technology of drugs and medical devices, including discovery, development, manufacturing, and regulation.

Read more about the ASCA Pilot Program

November 15, 2018
| Uncategorized

The Accreditation Scheme for Conformity Assessment (ASCA) is a program being developed by CDRH to reduce the number of sponsor questions in areas where the agency has observed inconsistent practices with respect to testing and conformance declarations. These inconsistent practices have then led to inconsistencies and inefficiencies in the review process.

See my previous consensus standards post for more information on how CDRH is working to make the submission process more consistent. Go to the pilot program page to read more about the program.

Text Copyright © 2018 Katrina Rogers 

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