VC Firms Seek New FDA Review Path, User Fee For "Novel" Devices

Article preview from "The Gray Sheet" - June 28, 2010

The National Venture Capital Association is in discussions with senior CDRH officials about establishing a separate, more efficient pre-market review pathway for especially novel devices, supported by a supplemental user fee.

VC Firms Seek New FDA Review Path, User Fee For "Novel" Devices

Article preview from "The Gray Sheet" - June 28, 2010

The National Venture Capital Association is in discussions with senior CDRH officials about establishing a separate, more efficient pre-market review pathway for especially novel devices, supported by a supplemental user fee.

"Early-stage device companies need a special, refined regulatory pathway for truly novel technologies," explained Paul LaViolette, a venture partner at SV LifeSciences, who previewed the proposal June 22 at a CDRH "Town Hall" meeting in Woburn, Mass.

"The pathway must be robust, collaborative and predictable," LaViolette said.

NVCA has in mind a process that addresses what the current expedited PMA program is supposed to accomplish, but doesn't. "Review times for expedited review for breakthrough products are longer than for regular reviews," LaViolette said.

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," he explained.

The review would be funded in part by an extra user fee, paid by the sponsor on top of the standard application fee.

"Investors would readily fund more expert resources rather than watch the passage of non-value-added time," LaViolette said.

In an interview, the VC exec clarified that there is not yet broad device industry alignment on the proposal, though NVCA senses that "CDRH leadership is open to considering it."

A proposal to add a new user fee is always potentially controversial, he acknowledged, but if the extra fees are transparently linked to enhanced productivity, it could be easier to swallow.

"For the relatively few novel submissions per year, it should be relatively easy to track resources, confirm incremental resources were applied and add supplemental/external resources as needed," LaViolette said.

- David Filmore

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