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FDA finalizes medical device post-inspection feedback guidance

  • Posted by: inetika
  • Category: GLOBAL NEWS

The US Food and Drug Administration (FDA) has finalised guidance on how medical device manufacturers can request nonbinding feedback on proposed actions to address issues raised during QSR inspections.

Specifically, the eight-page guidance addresses Section 702 of the FDA Reauthorization Act of 2017 (FDARA), which calls on FDA to improve its inspection process for device establishments by responding to device makers with nonbinding feedback within 45 days of receiving a request.

Within the guidance, FDA explains that requests for nonbinding feedback should come from either the individual at the company that received the Form FDA 483 during the inspection, or from someone who can demonstrate that they are the owner, operator or agent in charge of the establishment.

FDA also states that requests should be made within 15 business days to be considered timely, and that companies submitting a response to a 483 and request for feedback at the same time should include both in the same submission, but in as two separate documents.