Between 2007 and 2017, there was a 243% increase in the annual number of foreign device inspections and a 46% increase in domestic inspections, reports the FDA Center for Devices and Radiological Health (CDRH).
Therefore, on March 29, 2019, the agency issued a draft guidance to implement uniform processes and standards for those inspections.
In February, the agency issued a draft guidance to identify a new standardized mechanism for device establishments to request nonbinding feedback on actions proposed to address FDA Form 483 observations. The guidances were required by the FDA Reauthorization Act of 2017.
The agency reviewed its current procedures as of August 18, 2017. The review encompassed FDA guidances, manuals, programs, and internal standard operating procedures related to medical device establishment inspections.
As a result of the review, FDA identified uniform processes and standards and drafted revisions to procedural documents, including the Investigations Operations Manual and training materials to align with these processes and standards.
The draft guidance describes standardized methods of communication during the inspection process and identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.
The updates provide exceptions to existing processes and standards, an estimated timeframe for an inspection process and advanced notices of some records that will be requested from the establishment at the time of the inspection.
The agency’s 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.
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, the agency 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.”
Sixty-Day Comment Period
This is only a draft. The agency wants your comments by the end of May.
Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, Maryland, 20852.
