The Food and Drug Administration (FDA) issued final guidance on the review and update of device establishment inspection processes and standards. The agency is issuing the guidance to comply with the FDA Reauthorization Act of 2017, which requires the FDA to review and update, as needed, the processes and standards applicable to inspections of domestic and foreign medical device establishments in place as of August 18, 2017.
The final guidance details how the FDA will implement uniform inspection processes and standards and describes standardized methods of communication during the inspection process. Specifically, the guidance addresses the following:
- Pre-announcement notice and communication – The guidance notes that the FDA intends to make a reasonable effort to make contact with the firm to preannounce the inspection, which will be provided within a reasonable time before the inspection is scheduled to occur. The agency states that under the updated processes, investigators should also communicate with the firm regarding the planned timeframe and duration of the inspection.
- Standard inspection timeframe – The FDA standards for reasonable estimated timeframe of inspections range from 3 to 6 continuous business day. The agency notes that these standards are based on the type of surveillance inspection and extent of coverage needed for pre-approval inspection. Additionally, the FDA details that it may be necessary to extend the duration of an inspection for reasons that include follow-up on post-market safety information such as recalls, Medical Device Reports, and complaints received by the agency. The updated processes require investigators to communicate the additional time needed.
- Communication during inspection – The updated processes also require regular verbal communications about the status of the inspection between the investigator and the owner, operator, or agency in charge of the device establishment. The FDA details that these discussions may address observations not documented and may be recorded by either the agency or the firm.