FDA’s Pilot Program on Software Regulation Garners Praise

Industry and lawmakers are praising an FDA pilot program to ease the regulation of digital health products.

The Food and Drug Administration unveiled in a notice (FDA–2017–N–4301) July 27 a pilot precertification program that would lessen regulatory requirements for a select group of medical software developers.

FDA Commissioner Scott Gottlieb said the goal of the program is for precertified companies to submit less information to the agency than is currently required before marketing a new digital health tool.

“It’s rather unbelievable how fast FDA is moving in a positive direction,” Bradley Merrill Thompson, a health-care attorney at Epstein Becker & ...