September 17, 2018
Last week, as part of our Focus on Innovation, HIMSS Media ran a poll about the FDA's Pre-Cert program. The program isn't new, but we thought it would be a good moment to take the public pulse on a program that has seen a variety of reactions from inside the industry. Just under 500 readers responded.
In general, those opposed the program constituted a vocal minority — just 7.1 percent of...
February 1, 2018
The road to FDA clearance for medical devices may change radically in the next year.
Last summer, initial discussion began around implementing a pre-certification program for medical device companies, which would allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process....