Both China and US FDAs have established programs for expedited access to innovative technology. The programs are both now well established and remarkably similar. Both agencies offer consultation, guidance and hand holding – making life easier for innovators who may be new to dealing with regulators. But the big players are taking advantage too.
FDA this past week celebrated the first anniversary of its expedited access program for breakthrough medical devices. The program assists manufacturers through a collaborative approach. Devices in this program are ultimately destined for premarket approval (PMA) or de novo 510(k) clearance. IN such cases thorough pre-submission consultation pays dividends to the applicant. In a blog published yesterday FDA points out that the agency “including senior leadership, maintains a high level of interaction with sponsors and provides advice on efficient device development”.
In China, CFDA’s Innovative Devices program operates on very similar lines. CFDA offers advanced feedback from the Tyep Test Centres on device testing requirements, parallel consideration of product approval and product classification submissions and an case manager – a kind of internal CFDA champion who wnsures that the submissions are guided through the process and receive priority treatment.
US FDA …maintains a high level of interaction with sponsors
and provides advice on efficient device development
That’s not to say that these programs lower any standards, they don’t . Both agencies are clear that submissions must meet exactly the same regulatory standards that apply to all comers. The emphasis here is on extra assistance provided to sponsors to ensure they develop good supporting data and good submissions, and smoothing the flow of the review. Both agencies expect sponsors to have done their homework. China requires that applicants have well established design controls and a Design History File in place. This has always been the case in the US where 21CFR 820.30 (Design Controls) is the only part of the Quality Systems Regulations which must be complied with during product development and prior to manufacture. China CFDA has the additional requirement that the device be patent protected in China.
China’s program in particular has been enthusiastically taken up by industry – with the most recent (March 2016) figures showing more than 250 applications resulting in 55 device approvals since 2014. US FDA’s program is younger and has moved perhaps more cautiously with 29 designation decisions resulting in 17 acceptances into the program, and 12 refusals. No devices have yet been approved under the US program.
The key point here is that neither agency is lowering the bar on regulatory approval standards.
The China program has been taken advantage of by large and small players. The first international applicant accepted into CFDA’s program being Abbot Vascular with its absorbable stent system. California firm Endologix also found success with its NELLIX EndoVascular Aneurysm Sealing System. FDA’s program has seen applications mainly from US domestic sponsors. Similarly CFDA’s program has also been enthusiastically taken up by domestic applicants (although some of whom are local offices of international device firms).
The key point here is that neither agency is lowering the bar on regulatory approval standards. Both programs are all about providing additional guidance, consultation and input into the device development program, and a degree of hand holding to ensure the regulatory submission is dealt with expeditiously. In China there is also some priority processing. By their very nature innovative technologies are likely to be less well understood and potentially more risky. The last thing neither industry nor regulators need is a high profile failure of an innovator device so no-one’s dropping their guard – and that’s how it should be.
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