FDA should establish a regulatory division specifically focused on mobile health products, an industry group recommends.

In comments due Oct. 19 on the agency’s draft mobile medical applications guidance, the mHealth Regulatory Coalition calls for a division in FDA with a “dedicated staff responsible for reviewing submissions for mHealth products, responding to inquiries from industry, and educating agency staff, including field investigators.”

Such a move could help address the need for consistency as FDA applies its regulatory framework across mHealth technologies, the group suggests.

The mHealth Regulatory Coalition says a dedicated office “will undoubtedly be necessary” to tend to the many questions and submissions likely to flood the agency once FDA’s mobile health draft guidance is finalized.

According to the coalition, FDA could model the proposed division on the structure of the Office of In Vitro Diagnostic Device Evaluation and Safety within CDRH.

In July, FDA issued draft guidance to help clarify which types of mobile software applications face FDA regulation. (See “ Also see "Industry Applauds FDA Draft Guidance On Mobile Medical Apps" - Medtech Insight, 25 July, 2011. ” – “The Gray Sheet” July 25, 2011.)

The mHealth Regulatory Coalition believes a dedicated mobile health division “will undoubtedly be necessary to address the large volume of mHealth-related inquiries and submissions that will flood the agency once the draft guidance is finalized and as the agency develops additional guidance that impacts the mHealth industry.”

The group adds that “coalescing the knowledge experts within FDA today will help provide the necessary support for and regulation of an industry that is on pace to dramatically disrupt the medical device market in the United States.”

The mHealth Regulatory Coalition is composed of companies from the medical device, software and telecommunications industries, among others.

AdvaMed Seeks “Plain-Language” Guidance

Meanwhile, the medical device industry trade group AdvaMed is asking FDA to revise its draft guidance on mobile medical applications to better target software developers who may be unaware their products could be regulated as medical devices. (See “ Also see "FDA Wants Mobile App Guidance To Connect With Device-Reg-Naïve Developers" - Medtech Insight, 19 September, 2011. ” – “The Gray Sheet” Sept. 19, 2011.)

In Oct. 19 comments to the agency, AdvaMed asks FDA to revise its draft document based on public comments and to use more common “plain language.” It suggests the agency could either write a separate companion document to the guidance in plain language or create a plain-language version of the final guidance document itself.

“Many persons who produce mobile apps that will qualify as medical devices will not be aware that they are producing a regulated product,” writes Bernie Liebler, director of technology and regulatory affairs for AdvaMed, in a letter to CDRH policy advisor Bakul Patel. “Thus, they are unlikely to read or understand a standard FDA guidance, as it uses the terms and professional jargon common to the field.”

AdvaMed also urges FDA to “develop a means of getting the appropriate document into the hands of the right people. This task may be difficult, and the best approach is not at this point apparent to us."

By Monica Hogan

FDA Urged To Create mHealth Regulatory Office

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