Sponsored By

Outsourcing Arrangements Are Subject to Regulation

Did you know that CDRH can regulate your outsourcing arrangements? Well, it can, and attendees at the MD&M East conference this week learned how from Christy Foreman of CDRH's Office of Compliance. The authority is granted in section 50 of CFR 820 (the Quality System Regulation), which covers purchasing controls. Also relevant is section 80 of the QSR, which covers receiving, in-process, and finished device acceptance. Particularly important is that device manufacturers keep records of acceptable suppliers, contractors, and consultants, she said.

June 15, 2007

1 Min Read
Outsourcing Arrangements Are Subject to Regulation

CDRH will not look at the results of audits of suppliers. But it does want to see documentation of when audits occurred, and it will check the CAPA system to ensure that findings from audits were fed back into it. CDRH also urges that firms include an agreement that suppliers, contractors, and vendors will notify the firm of changes in their products or services.

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like