Alerts and Updates

FDA Issues Guidance on Procedures for Device Establishment Inspections

July 8, 2020

The guidance explains that FDA “intends to make reasonable efforts to make contact with the firm to preannounce the inspection.”

On June 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance on how it will implement certain inspection procedures for device establishments—facilities where medical devices are manufactured. The FDA’s guidance contains recommendations about (1) preannouncement notice (and communications prior to an establishment inspection); (2) inspection durations and timeframes; and (3) communications between the establishment’s representative and FDA’s inspector(s) during the inspection process.

Preannouncement Notice and Communication

The guidance explains that FDA “intends to make reasonable efforts to make contact with the firm to preannounce the inspection.” Under normal circumstances, the investigator will notify the owner, operator or person in charge of the device establishment by telephone prior to the facility being inspected. For domestic device establishments, this notification should be made at least five calendar days before the inspection. (For foreign device establishments, notice will generally be given more than five calendar days in advance of the inspection.)

Importantly, despite FDA’s intention to provide the device establishment with notice before an inspection, that intention does not translate to a delayed inspection in the event that the designated contact person fails to respond to the notification. FDA makes clear in the guidance that it “believes the firm’s failure to acknowledge the notification should not be a reason to delay the start of an inspection.”

Notwithstanding FDA’s standard practice of giving preinspection notification, as the guidance makes clear, FDA retains the authority to conduct unannounced for-cause inspections.

Standard Inspection Timeframe

According to FDA, reasonable, standard timeframes for inspections typically range from three to six continuous business days, based on (a) the type of surveillance inspection (either abbreviated or comprehensive) and (b) the extent of coverage needed for a preapproval inspection. The estimated duration of the inspection should be shared with the device establishment contact person when FDA makes its preannouncement notification. Where time frames for inspection must be altered, FDA recommends that the exceptions justifying the altered time frame should be communicated orally during the inspection.

Communication During Inspections

The guidance advises that, when possible, FDA “investigators should make every reasonable effort to discuss all observations” with the device establishment contact person either (a) as they are observed or (b) on a daily basis. The purpose of this encouraged communication—which may extend to observations not documented on Form 483—is to minimize errors and misunderstandings.

Like all FDA guidance documents, this guidance merely reflects FDA’s current thinking on the issues covered, and is not binding on the agency. Guidance documents such as this one are tremendously valuable to market participants. In this case, the statutorily required guidance could be quite helpful to a device manufacturer anticipating or otherwise planning for—or in the midst of—an FDA inspection.

For More Information

If you have any questions about this Alert, please contact Frederick R. Ball, Patrick C. Gallagher, Ph.D., Justin M. L. Stern, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact. 

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.