In responding to the FDA’s call for comments on draft guidance on mobile medical applications, the mHealth Regulatory Coalition has submitted not only feedback but also original, alternate draft guidance written by the coalition.
The coalition’s members include not only industry players but also healthcare providers, nonprofit associations, patient-advocacy organizations and healthcare payors. An early section of their sprawling, 220-page submission stated that they are proposing alternate draft guidance “because we believe that the draft guidance requires much more clarity to ensure that only those mHealth products that warrant regulatory oversight are regulated. While we believe that FDA has taken great strides in developing the draft guidance, we submit the enclosed proposed guidance to provide necessary details that are missing.”
In an Oct. 25 letter announcing the submission, the coalition said the submission had been more than one year in the making. Its content primarily covers which types of mobile health products FDA should regulate and at which classification.
Along with general comments on the FDA’s draft guidance, the submission included additional comments for the FDA’s consideration, responses to questions posed in the FDA’s notice of availability (published in the Federal Register in July) and four attachments: the original FDA draft guidance with specific comments from the coalition, the coalition’s proposed changes to the draft guidance, a 60-page white paper released last December titled “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth” and the coalition’s proposed guidance.
Among the coalition’s general comments:
- “We believe [the] approach to evaluating intended uses of a product articulated in the draft guidance is too broad and would result in unnecessary regulation of mHealth technologies. Instead, the FDA should focus regulation on moderate- to high-risk devices, exempting or excluding low-risk products.”
- “[T]he FDA should provide more specificity around its approach to regulation of mHealth products and commit to promoting investment and innovation in the mHealth industry.”
- “The draft guidance does not adequately address the roles and responsibilities of entities involved in … complex mHealth systems [with broad convergence and interoperability]. Therefore, we request that the FDA reconsider and clarify who is responsible for regulatory activities (i.e., pre- and post-market obligations) for mHealth systems that involve complex arrangements of medical devices and non-medical products.”
A statement on the coalition’s website said the mHealth Regulatory Coalition will cease to exist once the proposed guidance document is completed.