For a select few devices per year, FDA says it will speed up pre-market development times by intensifying staff efforts, with a particular focus on very early-stage, frequent interactions with product sponsors.

The new priority review program, termed the "innovation pathway," is the core component of a broader initiative announced Feb. 8 by CDRH to reduce the costs and time required for development of groundbreaking technologies.

It appears similar to a proposal that has been circulated by the National Venture Capital Association to create a new review path for novel devices. More generally, the CDRH initiative is intended to align with an increased focus both inside and outside of government on improving the global competitiveness of U.S. industry. (See " Also see "Device Innovation: Report Paints Dire Picture; Prez, FDA Take "Positive" Steps" - Medtech Insight, 24 January, 2011. '" – "The Gray Sheet" Jan. 24, 2010.)

"The majority of what goes through the FDA can be handled without novel pathways. It just has to be handled better" – Paul LaViolette, SV Life Sciences

But due to resource constraints, the reach of the priority review program in the near term is likely to be limited. And while members of industry are generally appreciative of the effort, some are skeptical it will lead to improvements.

It will get its first pilot run on a project funded by the Defense Advanced Research Projects Agency to develop a robotic prosthetic designed to restore near-natural arm, hand and finger function by employing a brain-implanted microchip. (See sidebar, "Military Gets First Dibs On New FDA Path With Brain-Controlled Prosthetic.")

Beyond that, the agency is accepting written comments from industry and others and will hold a public meeting March 15 before considering additional candidates.

150-Day FDA Review Commitment

For early-stage device projects that qualify for the innovation pathway, the center says it will commit to a 150-day review, which it says is about half the time it takes to review most PMAs. (Under current performance goals, 60% of standard PMAs submitted in a given year are supposed to be completed in 180 days; by 295 days, 90% are supposed to be completed.)

But the program puts much of its emphasis on efforts made prior to the actual review of an application, with the aim of addressing tough scientific and regulatory questions before a submission is made.

Under the proposal, qualifying submissions, which will be either PMAs or de novo classification submissions, will be assigned a review team before clinical trials are even begun.

CDRH will also designate a case manager to help the sponsor navigate the regulatory process from start to finish and to facilitate the more frequent communications with the review team that will be allowed under the priority review program.

Further, about four months into the "pathway," the sponsor and the center would create a written memorandum mapping out a plan and timeline for the entire development process, including clinical endpoints and key scientific questions.

The whole process would be closely monitored by the new Center Science Council, currently being formed, to ensure quicker resolution of challenging scientific issues, identify the need for external expertise and reduce unnecessary delays.

"Radically Different" Than Expedited PMAs?

CDRH already has an "expedited" PMA review pathway which, like the newly announced pathway, is intended for innovative devices that address unmet needs. If a submission is labeled as expedited, it is targeted with additional review resources.

But in practice, expedited reviews tend to take longer than standard PMA reviews, and FDA has had trouble meeting the associated user-fee performance goals (50% of expedited PMA reviews in a given year are supposed to be completed in 180 days, 90% in 280 days), the agency acknowledges.

The innovation pathway is a "radically different kind of approach" from expedited PMAs, CDRH Director Jeffrey Shuren stressed during a Feb. 8 press conference.

He explained that while expedited reviews target only the post-submission process, the new approach covers a much longer period. "What changes is the level of engagement from the center and certain commitments to actions we will take to help expedite both the development and the assessment of the technology," he said.

"We are front-loading our resources."

Shuren explained that the center will also work closely with sponsors if changes are needed either to the device design or a study protocol midway through the development process.

Reviewers will work with sponsors on clinical trial protocols designed to "anticipate the need for iterative device testing and redesign, as appropriate, and may employ tools to best leverage available data and minimize delays," according to a CDRH white paper.

But some in industry are not convinced these efforts will result in anything new.

Paul LaViolette, a partner with venture capital firm SV Life Sciences, said that while he applauds FDA's intentions, he is "a little bit cynical" about the specifics.

"I don’t see it as being truly substantive. In many ways, I perceive it to be a repackaging of the expedited review process," the former Boston Scientific executive said in an interview.

The expedited PMA review program, in his view, has not worked as planned largely because of a lack of sufficient resources. The same resource constraints will likely hamper the innovation pathway, LaViolette argued.

With regard to the new pathway's emphasis on early interactions on clinical and scientific issues, he also pointed out that pre-investigational device exemption meetings and pre-submission meetings are already relatively common for PMA devices.

LaViolette played a role last year in presenting a plan from the National Venture Capital Association for a distinct review path for especially novel devices. (See " Also see "VC Firms Seek New FDA Review Path, User Fee For "Novel" Devices" - Medtech Insight, 28 June, 2010. " – "The Gray Sheet" June 28, 2010.)

But he said that the NVCA proposal put more emphasis than FDA does on using external experts for breakthrough device reviews. The NVCA proposal also included the prospect of an extra industry user fee to help fund the more intensive review, although LaViolette acknowledges that, under current circumstances, companies probably would not support additional fees.

Likely Only One Or Two Devices Per Year

FDA acknowledges that due to limited resources, and to avoid holding up other applications, the innovation pathway will be employed only in very select instances.

"It is probably along the lines of one or two [submissions], or something thereabouts, that we will be able to handle in a given year," Shuren said.

In addition, he cautioned, "If we accept a device into the pathway, we probably could not accept many others that involve the same reviewers because there is other work in that product line that needs to get done."

Innovation Initiative: Planned Actions

Establish the "innovation pathway"
Streamline the de novo classification pathway, as announced in January
Establish a voluntary third-party certification program for U.S. medical device evaluation centers
Create a publicly available core curriculum for device development and assessment to expand domestic expertise on the topics
Issue guidance on when and how sponsors can leverage data collected outside the U.S. in FDA submissions
Advance regulatory science through internal agency research, public-private partnerships, inter-agency collaborations and public workshops
Enhance CDRH's horizon-scanning process to better prepare for next-generation technologies
Develop a network of external experts to serve as resources on scientific topics in which reviewers may not have expertise

The priority review program will be reserved for technologies with the potential to trigger "major transformation" in "the way medicine is delivered or the way the health care system works," explained Jonathan Sackner-Berstein, who in conjunction with the announcement was named CDRH associate director of technology and innovation to coordinate the innovation pathway process and related programs.

Specifically, the center is proposing that a device would have to meet one of four criteria to qualify: that no alternative exists to treat or diagnose a targeted life-threatening or irreversibly debilitating disease or condition; that the device significantly improves on currently available products for the condition; that it addresses an unmet public health need, as identified by the recently established multi-agency Council on Medical Device Innovation; or that it addresses a national security issue such as bioterrorism.

If a company is interested, or a CDRH staffer identifies a promising candidate, either can bring the prospect to the Center Science Council.

If a sponsor consents, the council would assess how revolutionary the device is and how well it meets the four criteria, as well as what resources are available within the center, and then decide within 30 days whether the product qualifies.

At that point, the center would have 120 days to complete an "innovation pathway memorandum" that maps out the development plan and addresses the plan of attack for "difficult, unresolved regulatory science questions," according to FDA.

Once testing is complete and a submission is made, reviewers would have 150 days to complete their assessment; days during which the sponsor is working to respond to possible information requests from reviewers would not be counted toward the 150-day timeframe.

Gesture Of Goodwill To Industry?

The broader innovation initiative unveiled Feb. 8 also includes proposals to certify U.S. clinical centers to conduct better-run, more efficient device trials, issue guidance for applying foreign-collected data to a U.S. submission, and develop a network of external experts that can be called on as needed by reviewers, among other efforts. (See box, "Innovation Initiative: Planned Actions".)

The announcement comes as the device industry is elevating its complaints that FDA policies and unpredictable review decisions are contributing to a deteriorating environment for innovation in the U.S., driving companies, they say, to focus efforts overseas or go out of business.

CDRH's decision last month not to move forward with some of its more controversial proposals as part of its 510(k) reform process was viewed as a positive sign by some firms, but it did not satisfy everybody. (See " Also see "FDA 510(k) Reform Plan Yields Mixed Readings" - Medtech Insight, 24 January, 2011. " – "The Gray Sheet" Jan. 24, 2011.)

Amy Thornton, an analyst with Washington Research Group, said the innovation initiative is likely intended as "a gesture of goodwill to the beleaguered medical device industry." But while companies will probably support it, "they are likely to view this as only the first step toward a more dynamic FDA that fosters innovation," she noted.

The first-blush official responses from the main industry lobbying groups appear to align with that assessment, expressing appreciation, but also a wait-and-see attitude. In particular, there is an emphasis on making sure attention is paid to improving things for the larger gamut of products that would not be impacted by the innovation pathway.

"We believe it is critical that FDA maintain its focus on bringing greater speed and consistency to the current review process and on addressing the full spectrum of concerns that have contributed to unacceptable delays and inconsistencies," AdvaMed CEO Steve Ubl said.

As SV Life Sciences' LaViolette put it, "The majority of what goes through the FDA can be handled without novel pathways. It just has to be handled better."

Initiative Reflects President's Priorities

FDA officials, for their part, clearly pushed the initiative as a means to improve the U.S. medical technology innovation environment.

"By the end of the decade, a combination of trends, including international competition, will test America's role as the global leader in medical technology innovation," FDA Commissioner Margaret Hamburg said during the press conference. "As a nation, we have important choices to make about how we move forward. FDA is eager and prepared to help lead the way."

The message was augmented by the fact that the day prior to the FDA announcement, President Obama, in a speech to the U.S. Chamber of Commerce touting his administration's efforts to improve the business environment, explicitly referred to FDA's efforts to improve the way it "evaluates things like medical devices, to get innovative and lifesaving treatments to market faster."

It was the second time in the past month that the president has evoked medical device regulation just prior to an important announcement by the agency.

In January, the day before CDRH released its near-term 510(k) reform plans, Obama alluded to the upcoming changes in a Wall Street Journal op-ed announcing his administration's intention to weed out unnecessarily burdensome regulations government-wide.

Shuren said CDRH's new proposal is intended to be consistent with an overall administration priority to facilitate innovation, while striking a balance with needed regulation.

The innovation initiative is intended to "set the ever-swinging pendulum in the right place between innovation and safety," he said.

By David Filmore

CDRH's Innovation Pathway: A Quicker Route For Breakthrough Devices?

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