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# Medical Device Inspection Changes in Reauthorization
- URL: https://www.fdaweb.com/medical-device-inspection-changes-in-reauthorization/
- Published: 2017-09-19T12:00:00.000Z
- Updated: 2026-09-14T22:51:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139655

Barnes & Thornburg attorneys say that the FDA Reauthorization Act of 2017 requires changes to FDA inspections of medical device manufacturers. In an online blog [post](https://www.natlawreview.com/article/fda-reauthorization-act-requires-changes-to-medical-device-inspections-alert?ref=fdaweb.com), the attorneys say the law requires the agency to implement a risk-based schedule for inspecting manufacturers of Class 2 and 3 devices. There also is now a fifth risk factor limited to devices — whether a manufacturer participates in international device audit programs that the U.S. participates in or recognizes — joining compliance history, recall history, inherent device risk, and inspection history as risk factors.

Under the reauthorization, FDA is required to make routine (not “for cause”) inspections uniform, with exceptions “as appropriate.” The bill also requires the agency to provide: 

- advance notice of routine inspections, including the type and nature of the inspection;
- a reasonable estimate of the inspection time frame, an opportunity for advance communications between FDA personnel carrying out the inspection and the owner, operator, or agent in charge of the establishment concerning appropriate working hours during the inspection, and, to the extent feasible, advance notice of some records that will be requested;
- regular communications during the inspection with the owner, operator, or agent in charge of the establishment about the status of the inspection, including an opportunity for either party to record the communications with advance notice and mutual consent.

The attorneys say that another change requires FDA to provide “non-binding feedback” within 45 days of a timely request on a manufacturer’s proposed response to observations on an inspection report “that involve a public health priority, that implicate systemic or major actions, or relate to emerging safety issues.”

FDA is to issue a draft guidance specifying how it will implement the changes within 18 months of the reauthorization act becoming law, and final guidance within another year.