Medical Device Link.

Originally Published IVD Technology July 2004

INDUSTRY NEWS

If all goes according to plan, the regulation of IVDs will soon be entering the electronic age. For the past year, FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) has been working on a pilot program that will enable IVD manufacturers to submit 510(k) applications on-line. OIVD officials say that this phase of the program (called the Turbo 510(k) project) will be implemented and available to manufacturers by December 2004.

Working with the Advanced Medical Technology Association (AdvaMed; Washington, DC), OIVD solicited IVD companies to participate in beta testing a prototype electronic 510(k) submission module. The companies that volunteered are the following: Abbott Laboratories (Abbott Park, IL); Beckman Coulter Inc. (Fullerton, CA); Becton, Dickinson and Co. (Franklin Lakes, NJ); Bio-Rad Laboratories Inc. (Hercules, CA); Cytyc Corp. (Boxborough, MA); Dade Behring Inc. (Deerfield, IL); Digene Corp. (Gaithersburg, MD); Focus Technologies Inc. (Herndon, VA); Roche Diagnostics (Indianapolis); Thermo Biostar, a division of Thermo Electron Corp. (Waltham, MA); and Ventana Medical Systems Inc. (Tucson, AZ).

In early June, OIVD held a training session on the electronic 510(k) module for these IVD companies. By the end of June, the companies will have used the system and given their feedback and comments to OIVD. Taking into account such comments, OIVD will make changes to the software, refurbish the submission module, and send out a new version by the end of July. The companies will then have until November to submit a real electronic 510(k) application. 

“OIVD doesn’t want the companies to submit first-of-a-kind products or devices that are so new and innovative that they may poorly fit use of a template review,” says Sousan S. Altaie, PhD, a scientific policy advisor at OIVD and the team leader of the Turbo 510(k) project. “So OIVD asked them to submit garden-variety products instead.”

OIVD officials believe that electronic 510(k) submissions will offer many benefits to IVD manufacturers. For example, one of the difficulties OIVD has encountered in turning over product reviews is that the data and studies included in 510(k) applications are often incomplete. OIVD must ask the companies for more data, creating additional review cycles. In order to reduce the number of cycles, OIVD developed a question-and-answer-based model for the electronic system, which gives IVD companies a clear idea as to what data they are required to submit. 

“FDA hopes that the use of this template will save time and standardize work processes for both industry and agency regulators,” says Altaie. “The agency also hopes that use of this process will provide an additional tool for streamlining premarket submission work.”

OIVD officials added that electronic 510(k) submissions would be voluntary for those IVD manufacturers that choose to use it. 

“OIVD will not be seeking legislation at this point to make electronic 510(k) submissions mandatory,” says Altaie. “If electronic submissions on a volunteer basis becomes successful, then OIVD might try to mandate them. But there are absolutely no discussions for making electronic submissions mandatory at all.”

Once OIVD has finalized the submission system, it will begin working on the second phase of the Turbo 510(k) project: the reviewer module. At this point, if OIVD were to receive an electronic 510(k) submission, officials would only be able to review it manually. However, OIVD is planning to develop software that allows reviewers to upload an application and then communicate with IVD manufacturers electronically. OIVD officials will also be able to review sending and submit their approvals electronically to manufacturers. While OIVD is projecting beginning work on the reviewer module next year, IVD manufacturers will not have to wait for this module to be completed before they can start sending their 510(k) submissions electronically.

OIVD is also considering extending the Turbo project to premarket approval (PMA) applications and de novo classification.

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