The FDA recently issued its final guidance intended to help the medical device industry determine applicable requirements for making a change to a medical device manufacturing site.
The final guidance is very similar to its 2015 draft version, with a few changes and clarifications as summarized below.
Premarket Approval Application Clarification
Clarifications regarding whether a change to a site is likely to require a premarket approval application (PMA) supplement or is eligible for a 30-day notice.
Preapproval Inspection Requirements
Some 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,” FDA added to the draft section on site change supplements versus 30-day notices. “Manufacturing process changes that are not directly associated with the facility move should be submitted separately and are not considered part of the manufacturing site change supplement.”
Additional Criterion for Determining Need for 21 CFR Part 820 Site Inspection
Regulators added a fourth criterion to the three presented in the draft under the approach used by FDA’s 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.
According to the guidance, CDRH and CBER will generally reach these decisions on inspections partly based on “a review of relevant recalls and adverse events, associated with manufacturing processes." The other three presented in the draft relate to dates of last site inspections and their classifications, relevance of the last quality system inspection, as well as “the risk to the safety or effectiveness of the device associated with the manufacturing activities performed at the new site.”
Contacting Regulators Regarding Site Inspections
The final guidance also states that “manufacturers may contact the appropriate office to discuss whether a pre-approval inspection may be required; the pre-submission process may be utilized for these interactions, if appropriate.” The polices are limited to firms with approved PMAs, product development protocols or humanitarian device exemptions.