FDA finalizes medical device post-inspection feedback guidance
The US Food and Drug Administration (FDA) on Tuesday finalized guidance formalizing a process for medical device makers to request nonbinding feedback on their proposed actions to address issues raised during inspections.The eight-page guidance finalizes a draft version issued last year and bucks concerns raised by industry groups, including the Advanced Medical Technology Association (AdvaMed), that the criteria in the guidance are “overly narrow” and preclude companies from getting feedback on certain issues. (RELATED: CDRH Drafts Method to Provide Feedback on FDA Form 483 Citations, Regulatory Focus 15 February 2019, Scope of FDA Draft Guidance on Nonbinding Feedback is Too Restrictive, Industry Argues, Regulatory Focus 26 April 2019).
Specifically, the 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 related to actions the company plans to take “that involve a public health priority, that implicate systemic or major actions, or relate to emerging safety issues.”
FDA says it revised the guidance in response to comments to clarify that it may still respond to requests that do not meet the statutory criteria for nonbinding feedback “through an alternative mechanism,” such as written correspondence, teleconference or face-to-face meetings.
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 says 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 as two separate documents. AdvaMed had petitioned FDA to give companies 45 days to submit their requests to avoid “rushed answers without a root-cause understanding of the underlying quality system deviations.”
The final guidance also includes minor clarifications to the statutory eligibility criteria for receiving nonbinding feedback that tailor the langue used to more closely follow the statute.
FDA