Industry Urges FDA To Codify Device Data System Enforcement Discretion

FDA should finalize guidance that would subject medical device data systems (MDDS) to enforcement discretion and quickly initiate formal rulemaking, key industry groups such as the Advanced Medical Technology Association and 510(k) Coalition advised the agency. Industry stakeholders also asked FDA to clarify its definition of the products and amend recently issued guidance on mobile medical applications to reflect the agency's changed position on MDDS oversight. While industry applauded the guidance as an example of FDA taking a more flexible...