US Food and Drug Administration (FDA) Issue New Regulatory Guidance

The FDA has issued a new guidance to manufacturers detailing when to submit a new 510(k) for changes or modifications made to that manufacturer’s previously cleared medical device. This guidance replaces the 1997 guidance document and is important to those considering making changes to a previously approved device.

Updates have been made to address issues associated with software and other rapidly changing technologies, and to provide greater clarity about changes that do not trigger the need for a new premarket submission.  Helpful examples are provided of modifications to devices involving such technologies to illustrate changes that require a new 510(k), and changes that may simply be documented in accordance with a manufacturer’s existing Quality Management System without prompting the need for a new 510(k) submission.

The types of modifications addressed in this guidance include manufacturing process changes, labelling changes, technology or performance specification changes, and materials changes. This guidance is intended to assist industry in determining whether a new 510(k) is submission is necessary whenever a manufacturer makes a change to its own legally marketed device.

To obtain a copy of the guidance document, click here for the full draft guidance.

Please do not hesitate to contact KD&A to obtain assistance with FDA requirements.