The U.S. Food and Drug Administration (FDA) has issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices.
When finalized, they will provide improved clarity regarding minor changes that do not require FDA review, and help ensure that the FDA receives appropriate submissions for modifications that do require premarket review by the agency; this clarification is intended to help ensure that devices with significant modifications are not being sold or distributed without FDA review. The finalized recommendations will replace an earlier guidance issued in 1997.
The documents apply to medical devices cleared through premarket notification; federal law requires manufacturers to submit a new 510(k) when changes or modifications made to an existing device could significantly affect its safety or effectiveness, or the manufacturer makes a major change or modification in the intended use of the device. They describe how manufacturers should consider the risk presented by the device modifications when determining if they should submit a new 510(k).
The FDA first drafted an update to the 1997 guidance five years ago, but the agency withdrew that draft guidance after passage of a 2012 federal law that required the agency to revisit its policy on 510(k) device modifications.
Updates in the draft guidance recommendations include:
- Guiding principles, including recommendations for manufacturers to conduct a risk-based assessment in order to determine whether a modification could significantly affect the safety or effectiveness of the device.
- Updated sections and flow charts to provide more clarity to manufacturers on when they likely are required to submit a new 510(k) for labeling, materials, technology, engineering and performance changes.
- Examples of specific device changes that likely require a new 510(k) and ones that likely do not in order to help guide manufacturers during their own decision-making on whether to submit a new premarket notification.
“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,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review.
“The FDA’s approach was informed by the invaluable feedback from key stakeholders, including industry and patient advocates,” Dr. Shuren continued. “They helped to shape our recommendations to ensure we strike the right balance between safety and effectiveness of modified devices and advancing device innovation.”
For more information, visit www.fda.gov
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