Data and Analytics — FDA’s Post-market Surveillance Data Proposals Press Forward -

FDA’s National Evaluation System for Health Technology, or NEST, as FDA calls it, is quickly gaining traction as one of the “gamechangers” for the medical device industry. FDA has been working with stakeholders for years to develop a system to better monitor the long-term safety and effectiveness of medical devices. NEST proposes to use real-world device data, purporting to get devices to patients sooner in a regulatory paradigm that puts more emphasis on post-market data. This could mean less pre-market data needed for approvals, shifting the data review and analysis to the post-market setting. Certainly this paradigm shift will address the complaints around FDA’s approval times and process, but there are significant concerns for a commercialization and approval strategy that shifts surveillance emphasis to post-market. Additional industry concerns include the sufficiency of the infrastructure, such as the lack of Unique Device Identifier codes reported on insurance claim forms.

Sen. Patty Murray, D-Wash., the ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, has pressed the issue of strengthening device post-market surveillance (like the NEST program) during recent hearings focused on the HELP Committee's medical innovation package. And the NEST program is just one of the key initiatives central to the ongoing negotiations for the fourth iteration of the Medical Device User Fee Act (MDUFA IV), which begins in 2017.