CDRH's in vitro diagnostic device office will extend its computer-based "Turbo 510(k)" program to all diagnostic manufacturers on a voluntary basis in October.

The electronic system, currently being piloted, was introduced to industry in May 2004 as a way to automate the current application filing process and ease creation of paperless submissions to CDRH.

The pilot began with an initial training-and-comment period last summer. Following an August release of the final software, industry participants began making electronic 510(k) submissions in September.

During an April 21 meeting of the Association of Medical Diagnostic Manufacturers in Rockville, Md., OIVD's Scientific Policy Advisor, Sousan Altaie, PhD, reported that the agency's IVD office has received five electronic submissions.

For now, industry and FDA stakeholders are favorably disposed to the submission tool.

At the meeting, Dade Behring Regulatory Affairs & Compliance Manager Andrea Tasker, a pilot program participant, noted that there are many advantages to "going from paper to electronic for the industry."

Tasker remarked on the usability of the electronic submission program, noting that FDA had incorporated and implemented the majority of industry comments into the final version.

Describing Turbo 510(k) as "quite simple [and] intuitive software," she said, "you're not going to need training on this.... It's pretty user-friendly."

The software also carries several time-saving features, such as links to user-fee cover sheets and the Code of Federal Regulations, a CDRH-recognized standards list, a product code classification system and an address book.

Despite the ease-of-use associated with the software, Tasker stressed that users "should have a good knowledge of creating a PDF" file. The program requires documents to be converted to PDF formatting, which could present additional challenges, she cautioned.

The Dade Behring exec highlighted two Center for Drug Evaluation & Research guidance documents - "¹ Creating PDF Review Documents" and "² Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format: General Considerations."

The guidances include tips on formatting fonts and inserting page breaks, Tasker explained. "I think they're excellent. As you can see, they originate from CDER, [which] has been doing this for a long, long time."

Concurrently, OIVD is taking steps to update its infrastructure and document-scanning capabilities as the office transitions to an electronic review process.

Although electronic submissions will occur on a voluntary basis, "we are going to make the reviewers in OIVD, at this point, electronically review [applications] - whether it is paper-based or an electronic submission," Altaie stated.

The FDAer reported that the agency has completed template changes as part of the second phase of "Image 2000 eSub Reviewer," scheduled for release at the end of April.

Image 2000, which also will be the archival database for all submissions, has been upgraded to accommodate working areas and generate more "real estate" on the screen for reviewers. It permits printing submissions - although the agency generally discourages this practice, Altaie noted.

Altaie further reported that FDA is working with the rest of the Center for Devices & Radiological Health to expand the electronic application process to other types of devices.

The diversity of products within CDRH makes it difficult to generate a single template, however. Altaie explained that it took a year to define the questions for the OIVD electronic submission, which applies to a much more streamlined category of products.

"It's hard to come up with the questions that relate to every single product we do," she said, quipping that "a tongue depressor doesn't have much in common with a CT scan."

Mandatory Electronic Review, Voluntary E-Submissions On OIVD Horizon

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