FDA Issues Proposed Rule That Could Benefit Mobile Health
On Tuesday, March 27, 2014 the FDA published a proposed rule in the Federal Register that would update how the agency classifies medical devices, including mobile health technologies, Health Data Management reports (Slabodkin, Health Data Management, 3/25).
Details of Proposed Rule
The proposed rule would simplify the process by which the agency classifies medical devices as required under the Food Drug Administration Safety and Innovation Act, which Congress passed in 2012 (Walsh, Clinical Innovation & Technology, 3/25).
Among other things, the rule identifies five categories of devices that would be placed in the lowest regulatory class, including:
- Devices that show uncontrollable known risks;
- Devices with an unknown or unfavorable risk-benefit profile;
- Devices that require a complete review of manufacturing information;
- Devices that must receive a premarket review for any change affecting safety or effectiveness; and
- Combination products that include a drug or a biological product that must be verified for safety and effectiveness (Tyler/Park-Suk, National Law Review, 3/24).
Mobile Health Implications
Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, said that mobile health care could benefit from the proposed rule.
Merrill said that new mobile health products "do not fit squarely into the old classification system."
He added, "As a result ... due to the lack of new classification regulations defining the new categories and the associated regulatory pathways, [mobile health] innovation has been frustrated," and mobile health developers have been unable to clearly "navigate the FDA system."
Thompson said he hopes the streamlined classification process will allow FDA to "do a better job of keeping up with these important new technologies, providing clear guidance for the new categories of technology being developed."
The proposed rule is available for public comment until June 23 (Health Data Management, 3/25).
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