FDA Provides Guidance on Review of Manufacturing Information in PMAs

Manufacturers making a modification to an approved device in the U.S. have new guidance on how to submit the required 180-day supplements to their premarket approval applications (PMAs).

The final guidance, “The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations,” clarifies the type of data to be submitted with the supplements and details the FDA review of manufacturing sections in PMAs as well as procedures the agency uses to determine whether facilities will be inspected after the submission of such filings. The guidance was published in the Federal Register last month.

“In most cases, only new preclinical testing is needed to demonstrate reasonable assurance of safety and effectiveness of the modified device,” the guidance says. “In some instances, however, limited confirmatory clinical data may be necessary to provide a bridge between the clinical data set for the original device and the expected clinical performance of the modified device.”

In the draft form of the guidance, the FDA said additional clinical data that is limited in scope could be included in 180-day supplements, as existing data on file should support such a filing.

The final guidance does not change the types of device modifications that may require 180-day supplements — such as changes to principles of operation, control mechanism, labeling, design, performance and testing requirements or acceptance criteria.

Comments on the final guidance can be submitted to the FDA at any time. More information on submitting comments can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/06d-0063-nad0002.pdf.