INDUSTRY TELLS FDA IT FACES CHALLENGES IN SWITCHING TO ELECTRONIC SUBMISSIONS

While voicing their support for the FDA's all-electronic submission system proposal, industry leaders are warning that the agency has a lot to consider before going forward.

The agency hopes an all-electronic system will help it more efficiently manage regulatory information, including speeding product reviews.

The Medical Device Manufacturers Association (MDMA), which represents small device firms, "looks forward to working with FDA to develop ways to make the submission process more efficient," MDMA Executive Director Mark Leahey said. "Properly structured, esubmissions would be a benefit to the FDA, patients and industry. However, much work remains to develop the proper system."

The FDA held a meeting in December to hear comments on its proposal. Several speakers at that meeting noted challenges involved in switching to an electronic submission system, such as a current lack of trained labor and standardized procedures. Small and midsize businesses will have a particularly difficult time due to their limited financial and technical resources, some speakers said.

Companies also debated whether the FDA should offer incentives for companies to submit applications in an electronic format before it becomes a requirement.

(www.fdanews.com/ddl/34_1/)