By Carmelina G. Allis –
Should FDA’s Center for Devices and Radiological Health (“CDRH”) regulate medical mobile apps? Or should medical mobile apps be regulated by another office within FDA? Or should they be regulated by a separate entity under the Department of Health and Human Services (“HHS”)?
At least one Representative in the U.S. Congress (Rep. Mike Honda, D-CA) believes that mobile apps deserve special attention and should be independently regulated. Rep. Honda is introducing in the U.S. House of Representatives the “Healthcare Innovation and Marketplace Technologies Act” (“HIMTA”), a bill which seeks to establish the “Office of Mobile Health” within FDA. The office would provide recommendations on medical mobile app issues, including establishing an app developer support program to ensure the developers are operating within privacy regulations and other HHS requirements. Reports (see, e.g., here and here) say that the bill is being introduced to ensure that competition, innovation, and entrepreneurship in the mobile app market are not stifled by regulatory issues that generally apply to traditional, non-software device types.
This proposed bill is likely to be welcomed by many mobile app developers – in particular the small or startup ones who still wonder why their products would be subject to FDA regulatory oversight at all. Most of those companies do not have the personnel, infrastructure, or sufficient expertise to navigate the monstrous and confusing FDA regulatory framework.
FDA has not set forth a clear regulatory path for medical mobile apps, and app developers are concerned about whether the regulatory burdens that FDA could impose on those products may limit their ability to timely enter the market. This is a fast-paced, quickly growing market sector, and the FDA premarketing process may be too slow and unnecessarily burdensome for these new technologies.
So the question still remains as to whether medical mobile apps should be regulated by FDA’s CDRH, another office independent from CDRH, or simply an office separate from FDA altogether. At least one person on the Hill thinks that these products should still remain within FDA, but regulated differently.
We will keep you posted on the outcome of this proposed bill and will post a copy of the bill once it is available.