Mass layoffs at the U.S. Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), will impact the medical device regulatory process, says Ben Wolf, partner in Alston & Bird’s Health Care Group.
Wolf, an FDA attorney, sat down with MobiHealthNews to discuss how staffing cuts at the Agency could lead to longer review times for medical device approvals...
When it comes to regulating medical devices, the status quo of relying on premarket evidence has its limitations: it’s expensive, it’s time-consuming, and it isn’t necessarily the best data to show how something truly operates in everyday life. But, according to a panel at the Connected Health conference in Washington, D.C, digital health tools that generate a trove of data could put us on...
On Friday the FDA issued a draft guidance document that revealed the agency intends to further deregulate medical device data systems (MDDS) and some medical image transfer systems. The FDA wrote that these types of devices are so low risk that they won't be regulating them at all.
Examples of health software platforms that have class 1 medical device clearance as an MDDS includes Validic's...
