The Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices final guidance has been released. The FDA posted a regulation down-classifying Medical Device Data Systems (MDDS) from Class III to Class I on February 15, 2011. Class I devices are subject to general controls under the FD&C Act. A draft guidance regarding MDDS was issued on … Read More
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Draft Guidance
The Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices draft guidance has been released to communicate the FDA’s standpoint on enforcing regulatory controls in regards to digital health efforts. The FDA understands that medical device access to digital technology has the opportunity to create more efficient and improved patient care. This draft guidance discusses how … Read More