CDRH Drafts Method to Provide Feedback on FDA Form 483 Citations

Regulatory NewsRegulatory News | 15 February 2019 |  By 

The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) issued draft guidance Friday to standardize a mechanism for a medical device establishment to request nonbinding feedback on actions such establishments propose to take to address an FDA Form 483.

The draft standardized method has five parts. These relate to submitting a timely request—as defined by the agency—the statutory eligibility criteria, the device establishment’s justification of the submitted request, the proposed actions and the nonbinding feedback. Legally, a device establishment’s request for nonbinding feedback must be submitted to the agency in a timely manner. CDRH proposed for this timeliness to be interpreted as “no later than 15 business days after issuance” of an FDA Form 483.

The proposed method also calls for a deadline on agency staff to respond to a request for nonbinding feedback within 45 calendar days, regardless of whether the specified criteria for such feedback have been met. In general, such CDRH nonbinding feedback would identify whether the actions proposed by the requester, “if appropriately implemented, appear adequate, partially adequate or inadequate.”

As part of its response to a request deemed partially adequate or inadequate, the agency also intends to provide an acknowledgement of the receipt, an explanation of why the proposed actions or elements of such actions were deemed inadequate and a recommendation to improve upon the proposed actions.

The 8-page draft guidance document fulfills a requirement from the FDA Reauthorization Act of 2017 (FDARA). FDARA provides a way for medical device establishments to hear nonbinding feedback, upon request, regarding proposed corrective and preventive actions on 483 observations, following an FDA manufacturing site inspection.

“Timely nonbinding feedback can help device firms determine whether proposed actions to address inspectional observations are adequate, possibly avoiding unnecessary investment in potential solutions not likely to satisfactorily address an inspectional observation,” the draft guidance and a release noted.

The draft guidance comes at a time when CDRH has worked to significantly increase the annual number of medical device manufacturing site inspections, both domestically and internationally. The center reported last November that the annual number of foreign medical device inspections conducted by FDA officials saw a 243% increase between 2007 and 2017, while US inspections increased by 46%. It also noted at the time that it has taken a “more aggressive approach” to issuing device warning letters.

Required nonbinding feedback, however, is contingent on the agency’s interpretations of the statutory eligibility criteria. These require that a request from either the owner, operator or agent in charge of a facility describe how one or more inspectional citations “involve a public health priority,” “implicate systemic or major actions” or “relate to emerging safety issues (as determined by [FDA]).”

The draft guidance describes situations where the agency believes that a request for nonbinding feedback would meet at least one of the criteria.

Draft guidance


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