FDA Issues Industry Final Guidance on Requesting Nonbinding Feedback

April 29, 2020

The Food and Drug Administration (FDA) published a final guidance document outlining how medical device manufacturers (MDMs) can submit a request for nonbinding feedback on issues documented during agency inspections and how the agency will evaluate and respond to such requests. By providing timely feedback, the FDA hopes MDMs will be equipped to quickly and effectively resolve safety and quality issues with their devices.  

Timely nonbinding feedback can help device manufacturers determine whether proposed actions to address inspectional observations are adequate, possibly avoiding taking unnecessary actions that are not likely to satisfactorily address an inspectional observation, according to the FDA.

“When device firms have questions about our inspectional observations, it’s important for communications between the agency and manufacturers to be clear and efficient so companies can address safety and quality issues as quickly and as adequately as possible to help them come into compliance with our regulations,” said Jeff Shuren, director of the FDA Center for Radiological Devices and Heath (CDRH), in a statement about draft guidance in February 2019.

The final guidance, Nonbinding Feedback After Certain FDA Inspections of Device Establishments, specifies that a request for nonbinding feedback must come from the “owner, operator, or agent in charge of the device establishment” no later than 15 business days after Form FDA 483 is issued.

The guidance also provides the following examples of Form FDA 483 observations for meeting the eligibility criteria for requesting nonbinding feedback:

  • Observations involve a public health priority and require resolution because such conditions have resulted in, or if unaddressed are likely to result in, the release of a violative product that may cause death or serious injury.
  • Observations indicate that systemic or major deficiencies with the quality system have resulted in, or if unaddressed are likely to result in, the release of nonconforming, violative, and/or defective finished devices that may pose a serious risk to public health.
  • Observations relate to an emerging safety issue that, if unaddressed, is likely to result in the release of devices that are likely to cause death or serious injury.

The medical device trade association AdvaMed had petitioned the FDA in its draft proposal to expand the 15-day window to 45 days to avoid “rushed remediation plans and incomplete feedback requests, leading to avoidable problems that emerge while remediation is underway.” AdvaMed also stated the draft set “overly-narrow eligibility criteria” that may prevent requests for nonbinding feedback. Ultimately, the FDA moved forward with the deadline and criteria originally outlined in the draft document.

This final guidance is one of the FDA’s A-list prioritized guidance documents that the CDRH intends to publish in fiscal year 2020.