Are you ready to sell your medical devices in the United States? Before you enter the US market, you need clearance from the US Food and Drug Administration, which means you probably need to submit a 510(k).
510(k) submissions, also known as Pre-Market Notifications, are required by the FDA for a range of medical device types and classifications. 510(k)s have unique content and format requirements – they are not identical to a European Technical File. And, the FDA's recent changes to 510(k) requirements make the submission process more rigid than ever. In this white paper, we will address your biggest questions about submitting a 510(k) in today’s market. What you will learn in this 10-page white paper:
We answer all of these questions and many more in this whitepaper.
Robert Seiple, RAC (US): Robert Seiple is Senior Regulatory Consultant at Emergo. He has over 35 years of experience with quality assurance and regulatory affairs in regulated industries, including medical devices, pharmaceuticals, and clinical research. His areas of expertise include 510(k) submissions, CE Marking, quality system implementation, training, and auditing.
If you are thinking about entering the US market for the first time, understanding the FDA regulatory requirements can be overwhelming. Information
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