Diagnostics & Imaging Week Washington Editor

ARLINGTON, Virginia — A pilot program within the office of in vitro diagnostics (OIVD) at the FDA's Center for Devices and Radiological Health (CDRH) is trying to cut down on the jungle of 510(k) submissions in paper.

It's called Turbo 510(k) and is modeled after the popular TurboTax software that millions of Americans use every year to prepare their income taxes.

"It's something that should look and feel familiar to most of you," Don St. Pierre, deputy director of new device evaluation at OIVD, told participants at the recent 15^th annual Device Submissions Workshop sponsored by the Advanced Medical Technology Association (AdvaMed; Washington) and held at the Doubletree Hotel in Arlington.

St. Pierre said the goal of the program has been to help standardize the submissions process for the industry, as well as making procedures more "real-time and interactive." He said the pilot program seems to be leading to quicker review times, often within 30 days.

"This is not taking what you would ordinarily submit and simply turning it into an electronic submission," he said. "It's more than that — it's about a new process. There are tons of benefits."

The project was introduced in May of last year and is part of the agency's push to modernize its IT infrastructure. Since then, the agency has been gathering input from diagnostic companies, with the first version of the software rolled out last August. Industry participants then began submitting Turbo 510(k)s in September. An updated version of the software incorporating much of the industry-recommended changes was available this past March.

The pilot program is scheduled to end in October and open more broadly by the end of the calendar year.

The updated version is sent out only on CD-ROM right now, but will be available for download online by July, St. Pierre said.

The Windows-based software uses a system of checks and balances — much like the tax software — requiring a user to provide different information, depending on the type of filing, and prompting the user for more information if there is an inconsistency or problem.

Different pop-up widows, color-coded prompts and online suggestions provide cues to add missing research data and other supporting documentation, much of it in the form of Adobe Acrobat portable document format — or PDF — files, a standard document scanning and manipulation software.

"As with any learning curve, there is a mind shift," he said. "But once you've made the shift, it is pretty easy."

Turbo 510(k) also makes available links to a standard user fee cover sheet, federal regulations and predicate 510(k) information, as well as an address book of contacts, product code classification help, and a list of CDRH-recognized standards.

"We have found — and hope — that this will really help to focus people and help drive them to more consistency," St. Pierre said.

Kay Taylor, who was involved with testing and implementing the software for use in submissions at Roche Diagnostics (Indianapolis), told the gathering that the program was "virtually idiot-proof."

Roche has filed three out of the five Turbo 510(k) submissions received so far by OIVD. St. Pierre said he hopes to have at least nine filings by the end of the fiscal year.

Taylor said that the FDA did "a really good job," not only with the software but by providing training opportunities and "quick, knowledgeable feedback."

Some of the drawbacks included limited details in the software manual, a few technology "hiccups," such as the amount of text allowed in particular fields. She also recommended coordinating with your company's IT department before installing the software because of certain network requirements.

She said she'd like to see the types of 510(k)s available under the software expand — such as with special 510(k) or different kinds of devices.

Roche plans to continue using Turbo 510(k), Taylor said.

"This has great potential, but it may not stay viable unless people participate," he said.

Donna-Bea Tillman, PhD, director of CDRH's office of device evaluation, said her office currently was "closely observing the progress" of the program to see how it could be expanded to other centers within CDRH.

"I know this is a repeated theme from me," she said, explaining that IT programs such as this would go away without proper user fee funding.

She encouraged more industry participation and feedback and suggested an industry workshop co-sponsored by AdvaMed to discuss the electronic review process and options, such as Turbo 510(k), in greater detail.