premarket guidance

By Dave Muoio February 6, 2019
The FDA released new draft guidance yesterday regarding premarket review for combination products — those with a mix of components that span across the agency’s drug, biologic and device product categories. The proposed premarket guidance, which may still be adjusted based on public feedback, broadly advises industry to submit a single regulatory application within the pathway that most closely...
By Dave Muoio December 21, 2018
The last few months of 2018 have been fairly active for digital health regulation, with the US FDA roughly a dozen noteworthy devices and consumer health products. But the bigger news out of the agency this quarter comes in the form of its market guidance. For instance, the very beginning of October saw the release of the Medical Device Cybersecurity Regional Incident Preparedness and Response...