Overall, industry says the device arm has made progress over the past five (5) years, prior to which complaints about the lack of regulatory clarity were more common. Steps to increase the speed of decision-making and improve the clinical trial paradigm appear to be helping, based on moves like the faster-than-expected approval of next-generation TAVRs made by Medtronic and Edwards Lifesciences. And the report’s statistics show the FDA is making progress.
Still, devices of all sorts are regularly approved in Europe years before they are permitted for commercialization in the U.S., so the FDA still has work do to meet CDRH head Dr. Jeffrey Shuren’s vision of U.S. patients “having access to high-quality, safe, and effective medical devices of public health importance first in the world.”
However, the Agency is getting pulled in opposite directions. One recent study by Harvard Business School blamed the FDA’s regulation and procedures for the delay, while another in the Journal of the American Medical Association said more evidence of safety and effectiveness is needed.
The FDA is trying to beef up its post-market monitoring and regulation of devices, and industry hopes it will grant device companies faster approvals and cut back on premarket regulations as a tradeoff. The report takes on added importance because Congress is considering a pro-industry overhaul of the device (and pharma) industry via the 21st Century Cures Act. It has passed the House of Representatives; however, has not yet received a vote in the Senate.
Here are some highlights from the report. All data is current as of March 31, 2015.
• 510(k) decision times for low- or moderate-risk devices decreased from an average of 132 days in FY 2010 to about 115 days in FY 2014.
• PMA decision times for high-risk devices decreased from an average of 352 days in FY2009 to 242 days in FY 2014.
• IDE decision times permitting use of a device in premarket trials fell from a whopping 442 days in FY 2011 to 30 days in FY 2015.
And the Agency touted several new regulatory initiatives such as:
• Moves to streamline the clinical trial process, including a guidance document encouraging the use of flexible adaptive clinical trial designs
• A shift in its benefit-risk analysis that includes differing collection of some data to postmarket settings so that commercialize can commence at an earlier data. There is a guidance document on this issue as well.
• Initiatives to collect more information about patient preference data. This kind of information informed the FDA’s decision to approve its device to treat obesity since 2007.
• And finally, the launch of the Expedited Access Pathway Program to speed up approval of selected “breakthrough devices.”
REFERENCE: Fierce Medical Devices; 14 AUG 2015; Varun Saxena