On Tuesday, FDA released a set of proposed guidelines on the regulation of certain mobile medical applications, Reuters reports.
According to FDA officials, oversight is necessary for mobile medical apps that pose risks for patients if they do not work as designed.
Details of the Draft Guidelines
FDA officials said that just a small number of the thousands of mobile apps would face agency scrutiny under the draft guidelines (Richwine, Reuters, 7/19).
FDA is seeking to regulate apps that:
- Are accessories to devices that FDA already regulates;
- Turn a mobile communications platform into medical device; or
- Offer suggestions about a patient's diagnosis or treatment (Overly, Washington Post, 7/19).
Some of the apps that would be regulated include ones that allow physicians to monitor patients' heart rates or view X-rays on smartphones or iPads (Reuters, 7/19). However, an app that holds medical records or provides training videos for physicians would not be regulated (Washington Post, 7/19).
In certain cases, software developers would have to demonstrate that their apps work as well as non-mobile devices that perform the same tasks before selling them (Reuters, 7/19).
In addition, FDA will not seek to regulate app stores or manufacturers of mobile platforms that are not involved in building the functions of health care apps.
The agency will accept comments on the proposed guidelines until Oct. 19 (Dolan, MobiHealthNews, 7/19).
Comments From FDA Officials
Bakul Patel, policy adviser in the FDA Center for Devices and Radiological Health, said officials hope the guidelines will help clarify FDA's expectations and spark more innovations in mobile health apps. He added that FDA wants to find the right balance between "promoting innovation and assuring safety and effectiveness" (Reuters, 7/19).
Jeffrey Shuren, director of the FDA device center, said, "We are focusing on what we think we should be focusing on," adding, "If something is to change in the future, then we would ... put out a new policy, [but] as of right now that is not what we are anticipating to do" (MobiHealthNews, 7/19).