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FDA MDUFA III Performance, By The Numbers
2015 Original PMAs And Panel-Track Supplements
2015 510(k) Clearances
2015 De Novo Classifications
2015 PMA Supplements

For first-in-class devices or major new device indications going through FDA, 2015 was a banner year.

The number of original PMAs for completely new high-risk devices and panel-track supplements for major new updates approved by FDA was at its highest level since 2001, according an analysis by "The Gray Sheet." Approvals jumped by 56% in 2015 from the prior year, and approximately doubled from the 2013 total.

And, as an FDA official points out, a similar milestone is reached when you count de novo classifications, which is the route to market for new, moderate-risk devices.

"If you look at what we might call 'novel' devices, sort of the non-510(k)s – original PMAs, panel-track PMA supplements and de novos – we approved in CY 2015 79 of these types of devices, which is the highest number in any calendar year since the advent of the user fee program," said William Maisel, the Center for Devices and Radiological Health's chief scientist, and acting director of the Office of Device Evaluation.

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"Gray Sheet" analysis of FDA database

Whether this is the new norm for approval volumes or is just a one-year spike remains to be seen, of course. There are likely multiple factors at play. But Maisel says the number of approvals in 2015 should be viewed as a validation of process reforms CDRH put into place and the hard work of the center's reviewers.

"A lot of the MDUFA III [user-fee] changes are certainly, I think, paying off," Maisel told "The Gray Sheet." "But it is really that, combined with the really hard work and dedication of our staff."

The increased approval numbers also seem match growing satisfaction in industry with FDA's handling of the review process.

The "interactive responsiveness of FDA ... has gone up dramatically," Paul LaViolette, managing partner and chief operating officer of venture capital firm SV Life Sciences, said in an interview. "It is easier to get a meeting. They are more prospective in wanting to meet with you. When they meet with you, the right people show up."

Those developments and stable agency resources have contributed to better review performance, suggests LaViolette, a former COO of Boston Scientific who has long been active in the device regulatory process.

Submission Volumes Up

However, one likely factor behind the 2015 approval volumes is simply a recent increase in submissions coming in from industry.

For instance, the number of original PMAs filed with FDA in fiscal year 2015, which stretched from Oct. 1, 2014, to Sept. 30, 2015, was significantly higher compared to the prior three fiscal years. (See Also see "FDA MDUFA III Performance, By The Numbers" - Medtech Insight, 19 November, 2015..) Some portion of submissions that came in during the first part of FY 2015 is likely reflected in the calendar year 2015 approval numbers.

"The changes to the program have contributed to a more conducive environment for medical device innovation in this country and ... companies are making decisions to bring their technologies here," CDRH's William Maisel says.

What caused submissions to spike is debatable.

Maisel argues that the increase in submissions is not a coincidence, but it is connected to FDA reforms that have made the regulatory process more inviting in the US.

For example, he says, the device center has made enhancements to its appraisal of investigational device exemptions for early-stage and pivotal studies, speeding up the start of clinical trials. (See [A#01150928014].) 2015 was a milestone year for the number of IDEs approved on the first review cycle – 165 – which is the most since 2002, according to Maisel. But that number has been steadily improving for several years, and he suggests the quicker path to trials is now transitioning into more submissions coming to FDA, and more approvals.

"I do think the wave is beginning to hit us," Maisel said.

More generally, reforms have made the PMA review process more transparent and efficient, making it more palatable for companies, Maisel surmises.

"The changes to the program have contributed to a more conducive environment for medical device innovation in this country and ... companies are making decisions to bring their technologies here," he said.

LaViolette, however, is skeptical of a direct connection here, noting that the time it takes to start the process for a device that will ultimately go through PMA review is long and unpredictable, and it is unlikely that any particular actions by FDA is going to increase that activity during a several-year period.

"What signal would folks have had ... three to four years ago to say, 'Let's start our pre-PMA companies now so we will have them all filed in 2015'? There is just no way to align that.

"You do not jumpstart PMA activity," LaViolette added. "You avoid PMAs if you think FDA is onerous, but you don't rush the PMAs if you think FDA is reasonable."

But it does seem more likely that recent policy changes have led to a jump in shorter-cycle de novo classification submissions. There has been a steady increase in de novos since Congress established the more-straightforward direct de novo route in FY 2013. (See Also see "Successful De Novo Petitions Double With Advent Of Direct Route" - Medtech Insight, 28 October, 2014..)

"You avoid PMAs if you think FDA is onerous, but you don't rush the PMAs if you think FDA is reasonable," SV Life Sciences' Paul LaViolette says.

Speed, Approval Rates On The Rise

Separate from the submissions volume, it is becoming apparent that average overall review times are declining.

While there was a spike in the average total decision times for original PMAs filed with FDA in FY 2013, the agency pointed out that there was an unusually high proportion of PMAs in that cohort that required advisory panel meetings that lengthened average times. The prevalence of panel meetings has returned to more normal, lower levels for FYs 2014 and 2015 submissions, leading to a decline in decision times and continuing an apparent trend from prior to FY '13. (See [A#01150601003].)

Meanwhile, the proportion of submissions that are approved by FDA – rather than tagged as non-approvable or withdrawn by the company – is on the rise. That might be a result primarily of the device center's enhanced emphasis on interactive review, touted by both LaViolette and Maisel.

"Having a phone conversation can often help explain in a way that documents and paper exchange does not. Being more interactive and having better quality submissions contributes" to higher approval rates, Maisel explained.

Sustainable Performance?

Some industry insiders who spoke on background with "The Gray Sheet" suggest that the 2015 approval total might just reflect normal variation.

But both industry's LaViolette and FDA's Maisel say they are positive about the future.

One key factor moving forward will be maintaining FDA resources necessary to support the review program, Maisel said. In some cases, more funding will be necessary, for example, to sustain the growing de novo program, which is not currently linked to any user-fee income, he noted.

But he is optimistic. "Certainly based on the number of submissions we have received, I would be hopeful that we would be able to sustain this [approval] number."

LaViolette also believes that FDA's current performance level is durable. "If you think about staffing, consistent funding – appropriation levels have been solid," he said. "And now you have improved efficiency and industry working more openly ... with the agency. I think what you have is better throughput."

FDA Hits User-Fee-Era Record For 'Novel' Devices: A New Normal?

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