Shifting Sands in Regulation

Attendees at this year’s Neurotech Leaders Forum observed a number of informative sessions that dealt with the changing landscape of the neurotechnology industry [see p7]. Although the industry still faces some challenges, there was general consensus that getting new neurotech products to market has become smoother in recent years.

In a session devoted to the regulatory climate in the U.S. and abroad, Cristin Welle of the University of Colorado, Denver, and a former FDA regulatory scientist, described how the gap is narrowing between the U.S. and Europe. While the U.S. still requires more extensive clinical trials than Europe and it still takes longer on average to get approval for an implanted device in this country, the situation is getting better, Welle said. The average time to get full IDE approval has fallen from 442 days in 2011 to about 30 days now. Welle credits much of this improvement to the new position of clinical trials director at the FDA’s Center for Devices and Radiological Health, who gets involved immediately if an IDE is disapproved. Also, as of 2012, an IDE can no longer be disapproved on efficacy grounds—only for safety concerns.

While full PMA approval in the U.S. still takes more time—”It’s not a compelling success story yet,” Welle said—obtaining 510(k) approval is now more on par with CE Mark. Meanwhile, the EU has been tightening things up. Beginning in 2020, medical device regulations will call for stricter pre-market review, with more clinical evidence of safety and effectiveness needed. Europe will also strengthen regulations for post-market surveillance.

Nick Langhals, Neural Engineering program manager for the National Institute of Neurological Disorders and Stroke, agreed that the U.S. approval process has improved. “The FDA of the past was more of an adversary. Now they’re playing a different role,” he said. “The FDA will now give you a lot of feedback before you even start the application process.” Langhals also highlighted public-private partnership programs that offer an opportunity for startups to streamline the commercialization process.

Also in the session, Victor Pikov related that the regulatory climate for medical devices in China has improved. The government loosened regulations for foreign-owned enterprises to establish manufacturing in China. Multinationals can now sell their products with the same access as domestic firms, though the sale of foreign-made medical devices to hospitals will now be more difficult. Pikov noted that the Chinese medical device industry is growing at an 18 percent annual rate.

While there are still regulatory hurdles for neurotech firms to get products approved in the U.S. and abroad, the situation has largely improved over the last 5 to 10 years and this should bode well for the growth of the neurotech industry.

James Cavuoto
Editor and Publisher

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