FDA releases updated draft guidance on 510(k) modification submissions

The FDA today released draft guidance providing updated recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market.

The recommendations cover how manufacturers should consider the risk of device modifications when determining whether they need to submit a new 510(k) application, and will replace guidance that is 19 years old.

“These draft recommendations are intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness. Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review,” FDA Center for Devices and Radiological Health director Dr. Jeffrey Shuren said in prepared remarks.

Included in the draft guidance are updated guiding principles including recommendations for risk-based assessments to determine safety and effectiveness associated with modifications, updated flow charts and sections covering when to submit new 510(k)s for labeling, materials, tech, engineering and performance changes and examples of specific device changes that would require new 510(k) submissions.

The FDA included a separate set of guidance to address changes that are specific to health care software.

“The FDA’s approach was informed by the invaluable feedback from key stakeholders, including industry and patient advocates. They helped to shape our recommendations to ensure we strike the right balance between safety and effectiveness of modified devices and advancing device innovation,” Shuren said in a press release.

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