MedCon: CRDH official offers tips for electronic submissions, eSTAR technical screening
COLUMBUS, OH – More than 33,000 submissions have been uploaded to the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Customer Collaboration Portal (CDRH Portal) since its launch, and FDA officials want more companies to use the electronic portal for their device submissions.“It is one of the best tools that has been created at CDRH since I've been there,” Josh Nipper, premarket operations director at the Office of Product Evaluation and Quality at CDRH, told attendees at the 2024 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA.
The CDRH Portal lets users electronically upload and track their submissions and includes the Center’s electronic Submission Template And Resource (eSTAR) program. The portal provides companies with the name and contact information of their reviewer, where in the process that submission is, and any upcoming deadlines.
Submission tracking was launched for traditional 510(k) submissions in 2021, special and abbreviated 510(k)s were added in 2022, and pre-submissions were added in 2023. Nipper said CDRH plans to include tracking for original premarket applications (PMAs) and PMA panel-track supplements this year.
Nipper emphasized that submissions must be uploaded by 4 pm ET on a business day to guarantee same-day processing.
“I've had the very uncomfortable and unfortunate situation of telling companies that submitting at 11:59 PT does not count as same day, and their file was deleted because they waited until day 180 on their due date,” Nipper said. “Please try to get those in. Don’t wait for the last day, because we do have limits, and we will delete your submission if we don’t get it in time.”
Over the last several months, Nipper said they have received about 90% of the total incoming submissions through the CDRH Portal, and the portal now contains about 1.87 TB of data. There are about 11,400 portal users in total and approximately 1,100 logins per week, he added.
Nipper acknowledged that a 4 GB file size limit has caused an issue for some submissions but noted the issue tends to happen in “situations where you have a lot of medical imaging that's eating up the space – a lot of DICOMS, MRI, and CTs.”
He strongly encouraged users to contact the CDRH portal team if they run into a problem uploading large files to the portal and, failing that, to revert to mailing the agency flash drives with files on them. However, he noted that there is most likely a way to get the files into the system with the help of the CDRH portal team.
“If you haven't, I heavily encourage you to stop mailing us flash drives and hard drives. Use the portal. It's great,” Nipper said.
eSTAR submissions
Since October 2023, submission through eSTAR have been mandatory for new 510(k) submissions, and there are separate versions of eSTAR for in vitro diagnostic (IVD) and non-IVD devices. eSTAR submissions are voluntary for IVD and non-IVD devices submitted through the De Novo and PMA processes, including original PMAs, PMA panel-track supplements, 180-day supplements, and real-time supplements.
An eSTAR for pre-submissions is also available, with 513(g) requests added to the system in March 2024. “There is now guided questions for 513(g)s that will help you walk through what should be submitted in those as well,” Nipper said.
Although he said it is still too early to tell, Nipper said it appears that their Refuse to Accept (RTA) rate has decreased since eSTAR submissions became mandatory for 510(k)s. The RTA rate for submissions used to be around 25%, but in the first 7 months since eSTAR, “we've culled that drastically,” he said. “Most things are getting in the door quicker.”
“Even if it's just a week of RTA back and forth, we’re seeing a drastic drop of the non-acceptance rates,” Nipper said. “[That] is the goal. The whole point is to get those review times down to where we're meeting the total time goals.”
Technical screening
Nipper said about 4% of submissions fail the technical screening, which looks for inaccurate responses or irrelevant documents within the first 15 days of submission. “It is not an adequacy review for substantive issues,” he said.
If a company does not provide a comment about how their device meets a relevant guidance document or a justification for why the guidance does not apply to their device, that would also fail a technical screening, he noted. Reviewers check whether each attachment question contains an attachment, and that it is relevant to the submission, and irrelevant attachments would also fail a technical screening.
An example of an inaccurate response would be when a company checks no in response to a question that applies to a device, like when a company should complete a biocompatibility section for an implanted device or answer cybersecurity questions for a device that connects to the internet. “One of the complaints we get from our review staff is it’s too easy just to check no,” Nipper said.
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