In a bit of a surprise move, the mHealth Regulatory Coalition has asked the U.S. Food and Drug Administration to revamp and republish its proposed guidance for mobile medical apps--but as a second draft, not a final regulation.
MRC made the request in a letter, crafted by founding member and attorney Bradley Thompson of Washington, D.C.-based law firm Epstein Becker Green, which it posted on its website on Tuesday. The letter lays out industry fears that FDA regulators, overwhelmed with more than 500 pages of industry comments from more than 100 interested parties, are planning to scale back the proposed guidance.
The letter indicates that the FDA may be considering publishing a "high-level," general guidance document in the short-term and holding off on more controversial issues--such as how to regulate accessories--until it has time to come to grips with them.
The MRC offers an option that would buy FDA regulators a bit more time to wrangle with the multi-layered complex regulatory proposal before they publish a final document. Their idea: Have the FDA publish a second draft guidance that incorporates any changes they have settled on, MRC co-founder Dane Stout tells FierceMobileHealthcare.
For example, if they've developed definitions for important terms such as "high-risk" or "general health and wellness," then go ahead and incorporate those into a second draft proposal, and allow the public time to review and comment on those issues. Then regulators can continue to work on more complicated issues such as how to handle clinical decision-support software or accessories.
"[C]ore elements cannot simply be cleaved off," Thompson writes. "[T]he integrity of the guidance system requires that FDA give public comments serious, mature consideration and respond with appropriate modifications, not just promises of future action."
We may know more next week. MRC officials are scheduled to have a meeting with FDA regulators Wednesday, Feb. 1, about the proposed guidance, MRC's comments, and the timeline for final publication, Stout says.
He estimates the process of re-issuing a revised draft proposal might add up to three months to the process, but would be time well spent. "This is a complicated issue. We just feel a measure twice, cut once, approach is warranted here," he says.
To learn more:
- read the MRC letter (.pdf)