FDA Plans the Transition of the QS Regulation to ISO 13485:2016

The FDA announced in May 2018 that it intended to revise its QS regulation, 21 C.F.R. Part 820, to supplant its existing requirements with the medical device quality management specifications of ISO 13485:2016.

The agency said that the action would “harmonize and modernize” the QS regulation and that the revisions to the regulation would “reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements.”

Proposed Rule Released in February 2022

On Feb. 22, 2022, the FDA released a proposed rule to harmonize its QS requirements with ISO 13845. The proposed rule was published in the Federal Register the next day (87 Fed. Reg. 10119).

The FDA stressed that an agency audits would not result in the issuance of a certification of conformance to ISO 13485, that it would not develop an ISO 13485 certification program, and that manufacturers with ISO 13485 certificates of performance would not be exempt from FDA audits.

For more information on how to transition from 21 C.F.R. Part 820 to ISO 13485:2016 contact Vincent Zottola at vzottola@tqsservices.com.

TQS also offers ISO 13485:2016 on line internal auditor training.

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