FDA's draft guidance may change medical device 510(k) review
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When manufacturers make changes or modifications to a device after FDA clearance, such as incorporating new technology or upgrading certain aspects, they are required to resubmit the device when those changes could significantly affect safety or effectiveness, according to the FDA. The draft identifies types of changes which trigger the need for a new submission—as well as those which don’t.
According to the document, regulations require resubmission when the device is one that “the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture or intended use.”
Significant changes requiring resubmission include modifications in a device that could significantly affect its safety or effectiveness, as well as changes in intended use.
“We are making the regulatory process for medical devices less challenging by better describing our expectations,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “In particular, manufacturers can continue to make innovative improvements to their devices and better plan for any updated submissions. This saves time and money.”
Changes which “significantly affect” safety and effectiveness are not only those which may be detrimental, according to the guidance, but also those which may be improvements. Modifications addressed in the document include manufacturing process changes, labeling changes, technology or performance specification changes and materials changes.
However, the guidance notes that the FDA grants review exceptions when manufacturers and the administration have worked to establish guidance for modifications to specific devices, such as contact lenses—which have their own guidance documents.
The draft is open for public comment.