FDA Guidance Aims to Smooth Path for New Devices
The FDA hopes to speed the development of new medical devices through newly issued guidance on the qualification of medical device development tools, published in the Aug. 10 Federal Register.
The tools could include a range of methods to evaluate medical devices or to assist in their development. For example, a blood-pressure monitor could record one effect of a device on a patient, or factor into the selection of a study group for a device trial.
Under the Medical Device Development Tool program, the use of the monitor in a certain context could be qualified by the FDA, removing the need to confirm its suitability in each subsequent individual application for device approval. The FDA hopes device developers will make qualified tools available to other developers, through licensing or other arrangements.