Category: FDA Updates

FDA Updates

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FDA Takes Steps to Modernize 510(k) Medical Device Program

The U.S. FDA has announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices.

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Recalls

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FDA Recalls Medtronic Insulin Pumps Due to Cyber Concerns

The U.S. FDA has recalled certain Medtronic MiniMed insulin pumps due to potential cybersecurity risks and recommends that patients using these devices switch their insulin pump to models that are better equipped to protect against these potential risks.