Last Friday, the Food and Drug Administration (FDA) issued two draft guidance documents that are aimed to develop earlier testing of medical devices on human subjects. The organization says the measures were put in place in order to foster innovation in the U.S. medical field.
The first document called for testing of prototype medical devices in the early stages of development on a small number of approved participants. The second measure outlines a process for approving applications from companies wishing to conduct clinical trials. It calls for each company wanting to test a device to be approved for an Investigational Device Exemption (IDE). This will allow the company to study the device on patients who have given consent to participate.
The new measures will allow studies to begin in the earlier stages of the development process previously allowed and permit for certain modifications to be made to the device without FDA approval.
Participation in the pilot program is limited to nine sponsor companies that the FDA says should focus on "Innovative, early-stage development technologies that are most likely to benefit from the efficiencies of the program."
The Connecticut Defective Medical Device Attorneys with Carter Mario Law Firm all too often see the injuries that mistakes with medical devices can inflict and the devastating after-effects they can have. Contact us today if you have been injured by a defective medical device.