The U.S. Food and Drug Administration (FDA) is launching three initiatives to support medical device development and safety.
The initiatives are as follows:
- Streamline the process of reporting device malfunctions through a summary reporting program.
- Publish a proposed list of device accessories that the agency believes are suitable for reclassification to the lowest-risk category of devices (i.e., class I).
- Release a draft guidance to clarify the how the agency issues certificates to foreign governments requested by firms that are exporting FDA-regulated medical devices outside of the U.S.
"The FDA is taking steps to advance innovation and surveillance for medical devices through the timely implementation of three new initiatives related to the recent user fee reauthorization," Commissioner Dr. Scott Gottlieb said in a statement released by the agency.
