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FDA Pilots Expansion Of Third-Party Review To Devices Without Guidance

This article was originally published in The Gray Sheet

Executive Summary

Only six of the twelve "accredited persons" have reviewed three or more 510(k) applications under the current third-party program, a requirement for participation in FDA's expanded third-party pilot.

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Third-Party Device Pilot Final Guidance Has Fewer Strings Attached

Accredited third-party reviewers will be allowed to evaluate 510(k)s in a medical specialty area for which they have not processed applications before under the Center for Devices and Radiological Health's Feb. 2 final guidance on third-party review.

Third-Party Device Pilot Final Guidance Has Fewer Strings Attached

Accredited third-party reviewers will be allowed to evaluate 510(k)s in a medical specialty area for which they have not processed applications before under the Center for Devices and Radiological Health's Feb. 2 final guidance on third-party review.

Oversight Chairman Greenwood Familiar With Third-Party Review Program

Any legislative proposal to expand FDA's third-party review program to applications containing clinical data would have a powerful ally in Rep. Jim Greenwood (R-Penn.), the newly named chair of the House Energy and Commerce/Oversight Subcommittee.

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