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# Guide on Device Inspection Process
- URL: https://www.fdaweb.com/guide-on-device-inspection-process/
- Published: 2020-06-26T12:00:00.000Z
- Updated: 2026-09-14T16:19:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147108

FDA has posted a [final guidance](https://www.fda.gov/media/139466/download?ref=fdaweb.com) entitled “Review and Update of Device Establishment Inspection Processes and Standards.” The guidance complies with section 702(b)(2) of the FDA Reauthorization Act of 2017, which directs it to issue guidance that specifies how the agency will implement uniform processes and standards that are applicable to inspections (other than for-cause) of foreign and domestic device establishments. The document also 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 guidance says FDA standards for reasonable estimated inspection timeframes generally range from three to six 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 pre-announcement,” it says. “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.”  

The document also addresses regular verbal communications during an inspection between the investigator and companies. “When time and circumstances permit, investigators should make every reasonable effort to discuss all observations with the owner, operator, or agent in charge of the device establishment as they are observed, or on a daily basis, to minimize errors and misunderstandings,” it says. “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.”