FDA Finally Issues Site Change Notification Requirements

When the FDA approves or clears a device, the FDA blessing is specific to a manufacturing site.

What constitutes a manufacturing site change and when should you submit a premarket approval application (PMA) supplement for a site change? What documentation should you should submit in a site change supplement?

Three years ago, the agency issued a draft guidance to help industry figure out the answers to those question. On December 14, 2018, the agency finally issued a 19-page final guidance on the subject.

The final guidance deviates from the draft in that it includes a few new clarifications around whether a change to a manufacturing site is likely to require a PMA supplement or is eligible for a 30-day notice. Certain policies were added to the draft section on whether a preapproval inspection may be needed.

“An applicant should submit a 180-day PMA supplement for using a different site…that affects the device’s safety or effectiveness. Manufacturing process changes that are not directly associated with the facility move should be submitted separately [via a 30-day notice or a PMA annual report] and are not considered part of the manufacturing site change supplement,” states the guidance.

The final guidance added a criterion under the approach used by FDA’s Center for Devices and Radiological Health (CDRH) and its Center for Biologics Evaluation and Research (CBER) to determine whether to conduct an inspection of a new manufacturing site associated with a site change supplement to evaluate implementation of quality system requirements under 21 CFR Part 820.

The agency said the guidance “should help firms manage the timeframes associated with implementing the changes in the manufacturing site and any processes, methods, procedures, qualifications and validations.”

The guidance only applies to a manufacturer of a device with an approved PMA, a product development protocol, or a humanitarian device exemption (HDE). The guidance does not address manufacturing site changes for devices cleared under premarket notification (510(k)) submissions, granted premarket authorization through the De Novo pathway, or approved and distributed as part of an investigational device exemption (IDE).

To read the entire guidance, click here.