FDA Drafts Guidance on Inspections of Medical Device Establishments

Regulatory NewsRegulatory News | 28 March 2019 |  By 

The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments.

FDA has updated processes and standards for uniformity within and across inspections other than for-cause and to establish a standard timeframe for such inspections of device establishments. The uniformity in FDA investigators’ approaches to these inspections “may inform firms’ preparation for the inspection and set baseline communication and timing expectations for each party,” the agency said.

The three-page draft guidance, which satisfies a requirement established by the FDA Reauthorization Act of 2017 (FDARA), provides for standardized communication methods during the inspection process. Practices for both FDA investigators and device establishments to facilitate the continuity of inspections are identified in the draft guidance as well.

The updates provide exceptions to such processes and standards, as deemed appropriate, an estimated timeframe for an inspection process and advanced notices, as feasible, of some records that will be requested from the establishment at the time of the site inspection. The uniform processes and standards are meant to help an inspection be conducted in a timely manner.

The agency’s inspections can range from three to six continuous business days, though factors such as the nature of FDA-observed deficiencies can impact inspection duration and extensions may be needed under certain situations.

With the uniform processes and standards, FDA will pre-announce a domestic inspection generally within five calendar days. For foreign inspections, this may be delayed due to countries’ clearances requirements. FDA investigators, “when time and circumstances permit,” are to “make every reasonable effort to discuss all observations with the management of the establishment as they are observed, or on a daily basis, to minimize errors and misunderstandings.”

FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance last month to identify a new standardized mechanism for device establishments to request nonbinding feedback on actions proposed to address FDA Form 483 observations. This draft guidance was also issued for FDA to comply with section 702 of FDARA. CDRH reported a 243% increase in the annual number of foreign device inspections and a 46% increase in that of domestic inspections between 2007 and 2017, underscoring the need for the new draft guidances to facilitate coordination before and after the inspection process.

The agency recently began compiling several data points on inspections for drug and device approvals in annual reports in line with provisions of FDARA. Its March 2018 annual report noted the median time between an FDA inspection request to the start of an inspection of a device establishment is 35 days.

A new software tool, meanwhile, that seeks to establish a standardized approach to the manufacturing site selection process has been in the works at CDRH’s Division of Biostatistics. The tool is called BLISS.

Draft guidance


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