The National Venture Capital Association is in discussions with FDA officials about establishing a more efficient efficient approval process for novel medical devices. The new pre-market review process would be limited to breakthrough technologies, typically brought forward by smaller companies, urgent in need and funded by venture capital.
“Early-stage device companies need a special, refined regulatory pathway for truly novel technologies,” explained Paul LaViolette, a venture partner, who previewed the proposal at an FDA meeting in Massachusetts. LaViolette should know as he is a veteran medical device executive and formerly the COO of Boston Scientific.
Under the proposal, FDA would establish a formal definition of a “novel” device, and would determine whether a candidate device meets that definition within 30 days of submission. If so, CDRH would assemble “a concentrated team of high-level review resources, including outside consultants, to review the submission. The review would be funded in part by an extra user fee, paid by the sponsor on top of the standard application fee.
The idea mimics what already exists for pharmaceutical companies in the form of a ‘fast track designation’ with the FDA. In 1997, FDA approved a mandate to “facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs”.
After more than a decade, it seems medical device makers are pursuing the same. While the entire industry is not yet backing the idea, enough momentum has been built that FDA leadership is open to considering it.
