Apple, Fitbit Among Companies Participating In FDA Pre-Cert Pilot Program

FDA has selected nine major medical device and technology companies to be part of its Pre-Cert pilot program, including Apple, Fitbit, Johnson & Johnson, Samsung, Verily and Roche, agency chief Scott Gottlieb announced during the Advanced Medical Technology Association's MedTech Conference on Tuesday (Sept. 26). A clinical decision support software industry source told Inside Health Policy the move likely signals these companies, including Apple and Fitbit, are moving into the class II medical device space long-term. In July, Gottlieb announced...