The FDA has clarified the type of data submitted with 180-day supplements for premarket approval applications (PMAs) for devices, which are usually submitted when manufacturers have a significant change to an approved, in a new guidance document.
The guidance, “The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations,” 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 Jan. 8 in the Federal Register.
“In most cases, only new preclinical testing is needed to demonstrate reasonable assurance of safety and effectiveness of the modified device. 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,” the guidance said.
The 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 and performance and testing requirements or acceptance criteria.
The guidance can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/06d-0063-gdl0002.pdf.