MobiHealthNews

Understanding FDA's new MDDS rule

To many people, including especially those who are not familiar with FDA's medical device regulations, reading the new MDDS rule is a bit difficult. We all like to read stories that have a beginning, ...
JD Supra

Still Comfortably Numb: FDA Issues Revisions to Previous MDDS Guidance

A device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: The electronic transfer of medical ...
JD Supra

There Must Be Some Misunderstanding: FDA Issues a Warning Letter to a Medical Device Company That Made the Wrong Decision on Regulatory Classification

not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system; intended for the purpose of ...
Insurancenewsnet.com

SEMDA’s LAST CALL for Medical Device and MDDS Companies Seeking Growth Capital

ATLANTA, March 7, 2014 /PRNewswire/ -- If you are a Southeastern Medical Device or Medical Device Data System (MDDS) company seeking growth capital, the MARCH 10 th APPLICATION DEADLINE to present at ...
RAPS

FDA’s Regulation of CDS Software: Will Physicians Have to Understand the Underlying Algorithms?

A key section of the recently passed 21st Century Cures Act explained to the US Food and Drug Administration (FDA) which categories of software should be exempt from medical device regulations. Most ...