FDAnews Device Daily Bulletin


May 31, 2006

In recognition of the sometimes dizzying pace at which innovation is taking place in the medical device industry, the FDA announced last week that it was launching an initiative designed to approve devices more quickly by modernizing the development process.

New technologies present challenges for both the agency and devicemakers "because the current paradigms for assessing the safety and effectiveness of new products may not be optimal" for an efficient review process, the FDA said in announcing its "Medical Device Innovation Initiative."

Innovations in devices are beginning to integrate engineering and biological approaches, the agency said. These technological advances include "complex products" such as diagnostic products using nanotechnology and combination products such as drug-delivery devices. This innovation runs the gamut from "giant leaps" of as short as 18 months to "incremental" changes that can take years.

The agency wants to better predict which new products are likely to be safe and effective earlier in the regulatory process. One of its primary goals is to ensure that clinical trials, product reviews and approvals, and manufacturing processes are conducted as efficiently and effectively as possible.

The Center for Devices and Radiological Health (CDRH) is promoting early interaction between the FDA and industry to optimize review times and foster innovation, the FDA says. ()a href="http://www.fdanews.com/ddl/33_22/" target=_blank>