Jul 1, 2020

The US Food and Drug Administration published the final version of a guidance document, Review and Update of Device Establishment Inspection Processes and Standards, the draft version of which was issued in March 2019. This publication fulfills a requirement established in section 702(b)(2) of the FDA Reauthorization Act of 2017 (FDARA), which directed the agency to explain how it would implement uniform procedures for standard inspections of medical device establishments.

The procedures outlined in this document are intended to make the inspection process faster and more efficient without causing undue hardship for device companies; they do not apply to for-cause inspections, which may still be carried out at any time without advance notice. The Regulatory Affairs Professional Society (RAPS) noted a major increase in FDA inspection volume over the decade leading up to FDARA, pointing to the need for increased standardization.

Announcing the inspection to the medical device establishment

The guidance document states that the FDA should issue a pre-inspection announcement providing at least five days’ notice in the case of domestic medical device establishments. Foreign facilities will usually receive longer advance notice based on different requirements of country clearances. This communication should also convey the intended type and nature of the inspection (i.e., surveillance or pre-approval), along with the estimated timeframe and duration. A standard inspection timeframe is to range from three to six consecutive business days. Finally, the announcement should specify if possible what records will be needed for the inspection.

Ongoing communications during the inspection

The document also addresses the need for ongoing communications between the inspector and the “owner, operator, or agent in charge of the device establishment” in the course of the inspection. Observations should be conveyed either as they occur or during daily meetings. Any extension or interruption of the standard timeframe should be discussed during the inspection. Communications may be recorded by the FDA or the firm being inspected, as long as this provision receives advance notice and mutual consent by both parties.

Related US FDA medical device and IVD regulatory resources:

Author

  • Timothy Herr

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