FDA believes that uniformity in investigators’ approaches to inspections, both before and during, may inform firms’ preparation for the inspection and set baseline communication and timing expectations for each party. The processes and standards identified below should facilitate practices that encourage continuity within an inspection and consistency across inspections.
Section 704(h)(1)(A) of the FD&C Act allows FDA to establish exceptions to the updated processes and standards, as appropriate.

Pre-announcement Notice and Communication
FDA intends to make reasonable efforts to make contact with the firm to preannounce the inspection. Under the uniform processes and standards, an investigator notifies the owner, operator, or agent in charge of a device establishment by telephone before their facility  Contains Nonbinding Recommendations undergoes an inspection. While FDA intends to seek acknowledgement of the preannouncement notification from the firm, FDA believes the firm’s failure to acknowledge the notification should not be a reason to delay the start of an inspection. Under the statute, this notification will be provided within a reasonable time before the inspection is scheduled to occur. For domestic inspections, the pre-announcement should be no less than five calendar days in advance of the inspection. The pre-announcement for foreign inspections is generally more than five calendar 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 surveillance or preapproval. 

Updated processes specify that during pre-announcement, investigators should communicate with the firm regarding the planned timeframe and duration of the inspection, to include appropriate working hours during which the inspection is likely to take place. To the extent possible, FDA should also provide advance notice of some records that may be requested during the inspection (e.g., certain procedures and any associated records). Under 704(h)(1) of the FD&C Act, FDA retains authority to conduct unannounced, for-cause inspections.

Standard Inspection Timeframe
FDA standards for reasonable estimated timeframes of inspections generally range from 3 to 6 continuous business days. These standards are based on the type of surveillance inspection (abbreviated or comprehensive) and the extent of coverage needed for a pre-approval inspection.
The estimated duration for each inspection should be shared with the firm at the time of preannouncement. Inspection duration is impacted by factors such as the complexities of the firm’s operations, availability of knowledgeable staff, and the nature of observed deficiencies. Additionally, it may be necessary to extend the duration of an inspection for a number of reasons, including for FDA to follow-up on post-market safety information such as recalls, Medical Device Reports, and complaints received by the Agency. Updated processes provide that, unless an investigator or the firm identifies a reason that additional time is needed and
communicates this verbally to the other party, inspections of both domestic and foreign device establishments should take place within a standard timeframe and occur over consecutive business days. FDA recognizes that circumstances may arise, for either FDA or the firm, where exceptions to these timeframes may be appropriate. Exceptions to the timeframe should be communicated verbally during the course of the inspection.

Communication During Inspections
FDA’s updated processes also address regular verbal communications during the inspection between the investigator and the owner, operator, or agent in charge of the device establishment about the status of the inspection. When time and circumstances permit, investigators should make every reasonable effort to discuss all observations with the owner, operator, or agent in Contains Nonbinding Recommendations charge of the device establishment as they are observed, or on a daily basis, to minimize errors and misunderstandings. These discussions may address observations not documented on the FDA Form 483 that require clarification. Communications may be recorded by either FDA or the firm, if there is advance notice and mutual consent by the other party.


Review and Update of Device Establishment Inspection Processes and Standards . Guidance for Industry
Document issued on June 29, 2020.