Gottlieb At The Medtech Conference: US FDA Commissioner Talks About CDRH Innovation, Puerto Rico, LDTs And More
Executive Summary
Check out the full video and read the highlights of US FDA Commissioner Scott Gottlieb's keynote address and Q&A from AdvaMed's 2017 Medtech Conference. Among the issues addressed: Gottlieb touted the agency's device center as the spark of innovation within FDA, and he provided a key update to the agency's digital-health regulation, his hopes for lab-developed test regulations and some substantive points on how industry should respond to the ongoing devastation in Puerto Rico from Hurricane Maria.
You may also be interested in...
Medtech's Unfinished Business For Congress In 2018: What's Ahead
US Congress successfully pushed through a user-fee bill in 2017 to help smooth the regulatory path at FDA for medical devices and other products, but other efforts, including several industry priorities, remain undone. On top on the list, of course, is the effort to repeal the device excise tax. But legislation is also on the table to address diagnostics regulation, telehealth reimbursement, and medtech cybersecurity vulnerability, among other issues. Here is a look at the medtech landscape in Congress in 2018.
FDA Tracks Critical Device Supply During Puerto Rico Hurricane Recovery
Continuing recovery efforts in Puerto Rico have US FDA focused on life-sustaining devices or those only made on the island. Meanwhile, manufacturers including Baxter, Zimmer, J&J and Abbott report varying impacts from the storms.
'Excellence' In Health-Software Design: US FDA Taps Nine Firms To Figure Out What That Means
The likes of Apple, Samsung and FitBit join traditional medtech players Johnson & Johnson and Roche, along with digital-health startups in a new US FDA pilot program intended to define best-practice software design as a means to "pre-certify" companies and reduce pre-market requirements. FDA's Bakul Patel and the CEO of one pilot participant, Pear Therapeutics, weighs in.