Director, Office of Strategic Partnerships and Technology Innovation, CDRH US Food and Drug Administration
Key global markets, including Australia, Canada, France, and the European Union, have released new guidance for medical device cybersecurity. FDA continues to mature their thinking in this space as well, as they prepare to re-release draft premarket cybersecurity guidance this year. In addition, the International Medical Device Regulators Forum (IMDRF) also released a detailed draft guidance on Medical Device Cybersecurity. The quantity of new expectations calls for a strategy to ensure that medical device manufacturers will be prepared to enter their preferred market without costly delays. Cybersecurity is an area where regulatory, quality, and engineering teams need to work closely together to ensure that their products are secure and this starts with a solid understanding of what the regulators will be expecting.
Identify common cybersecurity expectations across at least 4 global regulatory bodies, nincluding the IMDRF.
Explain key distinctions between the new cybersecurity guidances documents that were released in the past year.
Describe at least three new cybersecurity distinctions that need to be communicated to other functional groups within your organization.