FDA draft guidance on 510(k)s omits combination devices

Combination medical devices which bring together device components and drugs or biological products into a single unit are missing from new draft guidance from the FDA.

The guidance, released last week, covered recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market, replacing guidance that was 19 years old.

The new information, however, didn’t touch on combination products, which are becoming more and more common within the industry.

Included in the draft guidance are updated guiding principles including recommendations for risk-based assessments to determine safety and effectiveness associated with modifications,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.

“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.

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