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Software › Medical Device Data System

MoFo Life Sciences

EU: In Vitro Diagnostic Regulation Entered Into Force (Part 3 Of 3)

MoFo Life Sciences on

Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more

ArentFox Schiff

Devil Is Always in the Details: FDA Updates Device Classification Regulations To Remove Certain Software Functions

ArentFox Schiff on

On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products. This final rule takes...more

Hogan Lovells

Guidances galore: FDA finalizes multiple digital health guidance documents

Hogan Lovells on

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released a series of guidance documents addressing the agency's current views on software regulation following the changes implemented in the 21st...more

Cooley LLP

Alert: FDA Finalizes Guidance on Devices that Store and Transfer Data

Cooley LLP on

The Food and Drug Administration (FDA) on February 6th, finalized guidance on certain medical devices that store and transfer data, opting for a very light regulatory touch. In its guidance, the FDA states that it doesn't...more

Faegre Drinker Biddle & Reath LLP

What’s an MDDS? And Why Should I Care?

Faegre Drinker Biddle & Reath LLP on

Last month the Food & Drug Administration (FDA) announced still further relaxation of its oversight over anything qualifying as a “medical device data system,” or MDDS. The announcement should come as welcome news to a great...more

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