Our team recently held a seminar in California that covered topics related to the development of medical devices. This included a discussion on how to navigate the FDA approval process and to to develop software that conforms to the IEC 62304 standard. One area that was brought up by Steve Robertson is the increased FDA focus on cybersecuirty.
The internet of things ecosystem in general has varying approaching to addressing security needs. As Steve outlined however, medical device manufacturers need to give serious consideration to cybersecurity. The FDA issued a guidance in June of 2013 titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff.”
Steve mentioned in his presentation that although this is still a draft guidance it is to date the the best indication of FDA perspectives on cybersecurity. Medical device manufacturers adding connectivity would find it in their best interest to review this document to understand what FDA staff will be considering for FDA approval of devices.
The full presentation from Steve that also covers verficiation and validation as well as human factors design and their impact on FDA approval available here: http://www.mentor.com/embedded-software/multimedia/embedded-medical-fda-approved-steve-robertson