The FDA has issued a report entitled "Medical Device Innovation Initiative" and is seeking public written comments (due by April 11, 2011). The report proposes potential actions for FDA's Center for Devices and Radiological Health (CDRH) to facilitate the development, assessment, and regulatory review of innovative medical devices. These actions include: (1) establishing a voluntary, third-party certification program for U.S. medical device test centers designed to promote rapid improvements to new technologies during a product's development and clinical testing stages; (2) creating a publicly-available core curriculum for medical device development and testing to train the next generation of innovators; and (3) using more device experience and data collected outside the United States.
While the FDA is seeking comments on the Initiative generally, it is, in particular, looking for stakeholder views on the following:
- What should be the eligibility criteria for the Innovation Pathway?
- How should CDRH determine what types of technology should be allowed into the Innovation Pathway and at what point should they no longer be accepted as innovative products?
- What are the appropriate timeframes for review of submissions under the Innovation Pathway?
- What should be the criteria for clinical test center certification?
- What are examples of candidates for inter-agency or public–private partnerships to foster medical device innovation?
- What other actions should CDRH take to facilitate the development, assessment, and regulatory review of innovative medical devices while assuring their safety and effectiveness?
More information can be found here.