The FDA has now published its proposed rule simplifying its medical device classifications as directed by the 2012 FDA Safety and Innovation Act (FDASIA). This permits reclassification by administrative order versus the rulemaking (notice and comment) process. (Presumably this rule, as part of the latter process, sets up the process for the former.) In the US, the Food, Drug & Cosmetic Act (FDC Act), which FDASIA amends, has three classifications of devices from least restricted (Class I general controls) through premarket approval (Class III).
As published yesterday in the Federal Register, the class definitions are being amended to balance the assurance of safety and effectiveness with “the level of regulation necessary to provide such assurance should be closely tailored to the risk presented by a type of device.” The long-awaited changes are seen as highly favorable for mobile health devices and apps which for the most part do not fit neatly into the present Class I-III structure. (more…)
The mHealth Regulatory Coalition, which is a four-year-old alliance of legal and software companies in the health IT/software area, and whose most vocal spokespersons are well-known industry legal counsels Brad Thompson and Kim Tyrrell-Knott of Epstein Becker Green, has come out against the PROTECT Act (S 2007). PROTECT, which was proposed by Senators Fischer and King, would limit FDA regulation of certain ‘low-risk’ clinical software in the interest of fostering innovation and reducing regulatory burden. Original reports indicated that this responsibility would be transferred to the National Institute of Standards and Technology (NIST) [TTA 28 Feb]. According to Mr. Thompson, “The rush to avoid expert reviews of complex technologies with far-reaching health ramifications ignores the fact that we cannot separate the high risk from the low risk apps using broad terms in legislation.” His example: a theoretical smartphone app designed to diagnose melanomas from photos. PROTECT is being supported by IBM, athenahealth, Software & Information Industry Association, Newborn Coalition and McKesson. The bill also would exempt certain health IT software from being charged a 2.3% medical device tax, which is perhaps the ‘long game’ being played here by the aforementioned companies, as most Washington watchers give the bill as it stands little chance of clearing both houses of Congress and a congressional committee, much less being signed into law. The question remains: how best to speed less clinically significant wellness software to market without logjamming FDA. iHealthBeat summary, Clinical Innovation + Technology, MRC press release