FDA will begin to accept electronic submissions of device recall actions in the next several months, but it will still be some time until most pre-market device submissions can be made online, according to a staffer at the device center.

Currently, device makers submit correction and removal reports for products to an FDA district office in paper format. The reports are ultimately scanned and sent to CDRH for review and classification as a recall. But the process in many cases takes too long, said Eugene Reilly, a program analyst within FDA’s Office of Compliance, during a March 7 webcast sponsored by the Regulatory Affairs Professionals Society.

“If they are not very serious recalls, it takes a lot of time to get to us,” Reilly said. “We want to get them out faster.”

“If they are not very serious recalls, it takes a lot of time to get to us,” CDRH’s Eugene Reilly said. “We want to get them out faster.”

CDRH is preparing to soon open up FDA’s eSubmitter electronic submission software tool to correction and removal report submissions, Reilly said. eSubmitter is already employed by companies for voluntary electronic Medical Device Reporting, “turbo” 510(k) submissions to FDA’s diagnostics office and other agency submissions.

Electronic recall submissions will allow the manufacturer reports to be immediately routed to both the FDA district office and CDRH, saving time, Reilly noted.

Besides recalls, the device center is also prepping to open up two other submission types to eSubmitter – voluntary complaints from companies, consumers or others, as well as company reports from voluntary ISO 13485 audits, according to the staffer.

The audit reports would be submitted under a nascent CDRH program in which the center might agree to delay an FDA inspection of a facility based on satisfactory results of an audit conducted under international standards. (See Also see "Good Deal? Firms Seek Details On FDA ISO Audit Report Submission Program" - Medtech Insight, 23 August, 2010..)

Electronic Pre-Market Submissions Present A Challenge

But companies should not expect the device center to start accepting full-fledged electronic submissions anytime soon for pre-market submissions other than for in vitro diagnostics.

Electronic copies of pre-market device applications, on a CD or DVD, are already submitted to FDA along with paper copies, but such eCopies are not considered true electronic submissions.

In addition, certain study data associated with submissions often needs to be submitted electronically to allow for appropriate analysis by FDA reviewers. FDA issued an agency-wide guidance last month addressing a standardized approach for submitting study data electronically as a first step to developing regulations requiring the submission of standardized electronic study data. (See Also see "Regulatory News In Brief" - Medtech Insight, 20 February, 2012..)

But electronically submitting full PMA, 510(k) or investigational device exemption applications is still a ways off for most manufacturers, Reilly said.

Electronic submissions have been employed by the Office of In Vitro Diagnostic Device Evaluation and Safety under the turbo 510(k) program since 2004. (See Also see "Mandatory Electronic Review, Voluntary E-Submissions On OIVD Horizon" - Medtech Insight, 25 April, 2005..) But the device center has struggled to expand the concept to the broader device program, owing largely to the substantial diversity of products.

“There are so many different types of devices, it is really hard to get people to agree on what kind of electronic format we can get that will collect all of this information from everyone so that every type of device can be represented in the electronic submission,” Reilly explained.

The center also still needs to choose an appropriate data standard for pre-market electronic submissions and work out other issues, such as how to incorporate a user fee payment system.

“There is no electronic submission for non-OIVD pre-market submissions on the horizon at this time,” Reilly affirmed. Still, the center, particularly the Office of Device Evaluation, is “pushing to try to come up with an answer.”

CDRH Prepares For Electronic Recall Submissions; Pre-Market Still A Challenge

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