Robinson Bradshaw

Author: LaKeshia Banks

Proposed FDA Precertification Program Streamlines Review Process and Brings SaMD to Market Faster

The U.S. Food & Drug Administration (FDA) recently released an initial working model for its Software Precertification Program. The FDA proposed the precertification program to create a more efficient process for vetting and approving medical software and device developments, specifically for developers of Software as a Medical Device (SaMD). The model should appeal to mobile […]