Tag: Food and Drug Administration

Regulatory Uncertainty as FDA Draft Guidance on Mobile Medical Applications Reaches its Two-Year Anniversary

Many see great promise for patients and physicians utilizing mobile devices in health care. Growth of so-called “mhealth” has been fueled by faster, more ubiquitous technology, decreasing costs, and more user-friendly applications. However, regulatory uncertainty remains a barrier to the adoption of mobile health technology.  Two years following the FDA’s […]

FDA Issues Draft Guidance on Reporting Adverse Events for Medical Device Manufacturers

The Food and Drug Administration Center for Devices and Radiological Health released draft guidance on July 9, 2013 titled, Medical Device Reporting for Manufacturers.  Written comments may be submitted by mail or electronically to the FDA within 90 days.  When finalized, the guidance will supercede the 1997 guidance document with the […]