Top Democrats express concern on FDA's effort to relax regulations on digital health apps, other software

Democrats on the Senate health committee have expressed concern about how FDA plans to regulate medical software, including smartphone apps. FDA has been working with a number of companies over the past year to develop a program that would allow companies to sell some medical software without the agency reviewing it.

Democrats on the Senate health committee have expressed concern about how FDA plans to regulate medical software, including smartphone apps. FDA has been working with a number of companies over the past year to develop a program that would allow companies to sell some medical software without the agency reviewing it. Instead of approving specific products, FDA would "pre-certify" companies—based on criteria that has not yet been specified—and the companies would then be able to market certain software without requiring FDA review and other software with "streamlined" review, according to FDA Commissioner Scott Gottlieb in a September 2017 speech. In a new letter to the agency, Sens. Elizabeth Warren (D-MA), Patty Murray (D-WA), and Tina Smith (D-MN) wrote: "It is essential that changes to FDA's regulatory framework are done in compliance with the current statutory framework and do not compromise public safety." The senators expressed concern about how the process would work and how much information the companies will have to share with the public to qualify for pre-certification.