Legal Minute: 4 Must Do's When Choosing a Predicate Device for Your 510(k)

Darshan Kulkarni delves into the recently released draft guidance by the Center for Devices and Radiological Health (CDRH) outlining best practices for selecting a predicate device when preparing a 510(k) submission. This guidance underscores four key considerations.The draft guidance emphasizes the significance of technological characteristics. If the new device shares the same technological characteristics as the predicate device, the 510(k) summary should include a comprehensive summary of...

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Welcome to DarshanTalks! We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there! Powered By The Kulkarni Law Firm -  Helping regulators see your business the way you do. We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.