ARTICLE SUMMARY:
China appears ahead of most countries in adopting an online, electronic system for pre-market device submissions. The country says its eRPS platform has helped speed emergency approvals and reduce face-to-face contacts amid the coronavirus. Also: a brief look at FDA’s progress toward eSubmissions.
China is touting its 2019-launched electronic registration system (eRPS) as a key factor in expediting COVID-19 diagnostic and device reviews. The country’s National Medical Products Administration is ahead of some other device authorities, including FDA, in adopting pre-market online, electronic device submissions, for emergency and non-emergency use.
As of March 13, NMPA approved 17 novel coronavirus assays—11 nucleic acid tests and six immunoassays—and dozens more emergency-use medical devices. Many of the products have gone from declaration to review and approval within 24 hours, according to the agency. NMPA says (link in Mandarin) eRPS is a key reason, because it allows reviewers to start work on applications quickly from anywhere and work on them efficiently, including streamlined communications with sponsors.
“As the world's first national paperless medical device registration and declaration system, the eRPS system has obvious advantages in saving time and resource costs and improving the quality and efficiency of registration declarations, and plays a huge role in improving the quality and efficiency of review and approval,” NMPA said, according to a translation of a February 28 statement from the agency.
NMPA officially launched eRPS last June. At the time, sponsors of domestic Class III devices, imported Class II and III devices, as well as clinical trials and innovative medical device special review submissions, were given the choice to use the online submission platform or continue to submit standard paper applications. In November, the requirement ramped up, where device sponsors still had the option to use paper submissions, but if they did, the application had to follow the standardized eRPS format. By the end of 2019, more than 80% of device registration submissions were coming through the online platform, according to NMPA.
As the COVID-19 outbreak hit China, officials saw an opportunity to leverage the platform as a means to help reduce virus infection by limiting face-to-face interactions. The eRPS system allows a device company to make a submission electronically using a secure “Certificate Authority” digital key. The reviewer is then able to access the submission from anywhere, including home, with a Certificate Authority, according to NMPA.
In late January, as the coronavirus crisis escalated in China, NMPA issued a notice requiring use of eRPS by anyone who had a Certificate Authority. In the same notice, the agency suspended in-person document submissions, as well as face-to-face meetings and consultations. The result, the agency says, contributed to fighting back transmission of the virus, while speeding up availability of products to help address the epidemic.
FDA’s Steps to Standardization
China’s eRPS system is built on a template that harmonizes with format guidelines from the International Medical Device Regulators Forum (IMDRF). Electronic device submissions seem like a low bar to meet in our modern, online world. But the challenge for device regulators is that the massive diversity in medical devices makes it difficult to establish a standardized template that has broad application.
Addressing that standardization challenge has been a key focus of FDA for years. But the US agency is still in an early stage of transition to all-digital pre-market device submissions.
To be sure, FDA is working with labs and manufacturers on rapid turnarounds on Emergency Use Authorizations for COVID-19 diagnostics, including leveraging an interactive “pre-EUA” process. (See “Addressing a Global Health Emergency: Tips on Applying to FDA for a Novel Coronavirus Diagnostic EUA,” Market Pathways,February 7, 2020.) However, it is not getting the same benefits China describes from eSubmissions. It is still routine for an application to be uploaded to a CD and mailed to the agency. During the current emergency, FDA apparently has a limited set of staff at headquarters loading these “eCopy” submissions onto FDA’s electronic system, so reviewers can access the applications remotely.
FDA has made gains in standardizing its internal 510(k) review process by leveraging its so-called “Smart” review template, which guides reviewers to improve application-to-application consistency. The challenge is to develop a broadly applicable electronic submission form for sponsors that cleanly feeds information into the Smart template.
For years, it was a requirement for device companies to submit a paper copy along with an eCopy (CD, DVD, or flash drive). That changed last December, when FDA issued a rule removing the need for a paper copy and requiring a single electronic-format submission. But while FDA has an established Electronic Submissions Gateway (ESG), which the device center relies on for securely receiving adverse event reports, unique device identifier data, and other information, the ESG is not a routine tool for 510(k)s or other pre-market applications.
FDA has run some pilots to test the potential for sponsors to use the agency’s “eSubmitter” software to format electronic submissions, which can be submitted either via ESG or as an eCopy. Currently, the agency is running the “Quality in 510(k) Review” pilot, where sponsors of certain device types can generate standardized 510(k)s with eSubmitter and FDA promises accelerated 60-day decision times. Since the pilot’s 2018 launch, 19 510(k)s have been cleared through the program in an average of 53 days.
More recently, in February, FDA rolled out the eSTAR pilot, seeking nine participants to create 510(k) submissions with the new PDF-based Submission Template and Resource platform. Its an alternative to eSubmitter that doesn’t require specialized software, touts a more intuitive interface, and is structured similarly to CDRH’s Smart template.
Ultimately, an FDA spokesperson tells Market Pathways, the device center hopes to build out the use of eSTAR. In parallel, the center plans on developing a new submissions portal to replace the ESG that is designed more specifically for device submissions and can track submission information.
“The FDA is committed to streamline the pre-market notification review submission process,” the agency’s spokesperson said.
But these new templates and platforms will have to wait. For now, the agency must put the tools it currently has at its disposal in its all-hands-on-deck response to the COVID-19 emergency.
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