FDA floats 5-day notice for device inspections in draft guide
- FDA outlined Thursday how it plans to alert medical device manufacturers of a forthcoming inspection, the estimated length and how it plans to communicate with the facility before and after.
- The new draft guidance fulfills an obligation under the FDA Reauthorization Act of 2017 (FDARA) to adopt uniform standards around not-for-cause inspections. The law requires the agency to announce inspections "within a reasonable time before such inspection occurs," and to communicate with the facility operator before and during the inspection.
- The draft guide is not binding and allows for extension of the estimated timeline for an inspection, which Hyman, Phelps & McNamara device attorney Jeff Gibbs said potentially limits its impact.
FDA will alert domestic device firms of forthcoming inspections at least five calendar days ahead of time, generally speaking. It estimates a standard inspection will take three to six business days, according to the new draft guidance.
"FDA has already been preannouncing inspections in the United States," Gibbs said. "This document at this high level does not represent much of a change in practice; it’s aspirational, not binding."
But one requirement under the law, outlined in the draft guidance, to give firms advance notice of what records an inspector expects to request "to the extent feasible" may be significant depending on implementation. Gibbs said the practice currently happens "very rarely."
AdvaMed, which lobbied Congress throughout development of the reauthorization of the device user fee law, said on its website the FDARA requirement will lead to "efficient inspections that provide FDA with needed information while minimizing the disruption of the inspected facility and preserving FDA and industry resources."
FDA notes the pre-announcement for foreign device facility inspections may be greater than five days "due to the requirements of particular country clearances."
"For both domestic and foreign inspections, the notification should include information about the type and nature of the inspection, such as whether the inspection is scheduled as abbreviated, comprehensive, or pre-approval," the draft guidance states.
During inspections, the draft guide states FDA inspectors "should 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."
Inspectors often already have verbal communication in closing a day of inspections, according to Gibbs. But the draft guidance may eventually formalize the practice when finalized.
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