Are you marketing a wireless, networked, or interconnected medical device in the United States? If so, you can expect intense regulatory scrutiny from the US Food and Drug Administration (FDA).
The FDA pays special attention to cybersecurity vulnerabililties in medical devices, and has established cybersecurity control requirements for network, wireless, and similar technologies. Manufacturers must take extra measures to ensure the cybersecurity of their device throughout its lifecycle. In this white paper, we address your biggest questions about US regulatory requirements for wireless medical devices, including:
- What is required in a FDA 510(k)?
- What is required in a FDA Premarket Approval (PMA)?
- What post-market risk management measures does the agency recommend?
- What are the components of a compliant cybersecurity framework?
We answer all of these questions and more in this 4-page white paper.
About the Authors
Richard Vincins, CBA, CQA, RAC (US/EU): Richard Vincins is Vice President, Quality Assurance Consulting at Emergo. With over 25 years of experience in the medical device industry, Richard's areas of expertise include ISO 13485, US FDA QSR, and many other country quality system implementations including Canada, Japan, Brazil. Additional areas of expertise include US FD A 510(k) registration, European CE Marking, multiple country product registrations, risk management, and clinical investigations. Richard's main focus and responsibilities are advising compliance of medical device and IVD companies to the ever expanding regulatory requirements.
Stewart Eisenhart: Stewart Eisenhart is Senior Regulatory Analyst at Emergo. With more than 17 years of experience in written communications, he previously served as a journalist covering financial technology, healthcare, and insurance.