Concise analysis of mHealth regulatory environment (US)

If you–like most rational people–have some confusion in deciphering the current FDA state of affairs as it applies to mHealth, this summary from major law firm Foley & Lardner will be helpful. Written by special counsel for healthcare/mobile health Monica R. Chmielewski, it defines in few words FDA’s classifications, which mHealth technologies are, and which are not, subject to FDA oversight. In particular, MDDS (medical device data systems) were recently downgraded from Class III (the greatest oversight with pre-market approval) to Class I. FDA has also recently finalized recommendations in a guidance document for medical device manufactures for managing cybersecurity risks. mHealth Technology – Development in an Uncertain Regulatory Climate (Health Care Law Today)

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