FDA Releases Document to Clear Up Confusion over PMA Supplements

The FDA has provided its thinking on when medical device companies must submit a PMA supplement as a result of a manufacturing site change.

With draft guidance released Oct. 21, the FDA aims to define what constitutes a manufacturing site change, as well as when a company should submit a related PMA supplement. In addition, it describes the documentation that should be submitted as a result of the change and what factors the FDA intends to consider when determining whether to conduct an inspection prior to the approval of the site change. The document doesn’t cover manufacturing site changes for devices cleared under the 510(k) process.

The document, written in a Q&A format, informs industry that the agency intends to consider such a change to have occurred when the site was not approved as part of the original PMA, or if it were part of the original PMA but for different manufacturing activities.

“Under these circumstances, the different site would have no experience with either the process or the technology, or a similar process or technology, for manufacturing the same or a similar device, and FDA would not have had the opportunity to evaluate the change,” according to the draft document.

With such a change, the company would have to submit a 180-day supplement, according to the FDA.

If a site is among those already approved, changes may be submitted as 30-day notices. The same applies to changes that are for performance of the same or similar activities or devices as those at the PMA-approved site.

The agency offers examples of when it expects a site change supplement and when a 30-day notice is appropriate.

In addition, the agency provides 13 items it would like to see included in a site change supplement, including a diagram of the proposed new manufacturing, processing, packaging and distribution sites and a description of the equipment and processes that would be affected by the site change.

Need for Inspection

The document also lists factors the agency will consider when determining whether to conduct an inspection related to a site change:

• The dates of the last inspections of the current and new sites;
• The classifications of those inspections;
• The relevance of the last QS regulation inspection to the moved manufacturing, processing or packaging activities; and
• The risk to the safety or effectiveness of the device association with the manufacturing activities performed at the new site.

The document replaces earlier draft guidance, Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval, which was unveiled in 1999. A copy of the draft guidance document is available here: http://www.fdanews.com/10-26-15-site-change.pdf. — Elizabeth Hollis