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Medical Devices › Surveillance

MoFo Life Sciences

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 4 Of 6)

MoFo Life Sciences on

After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our...more

McDermott Will & Emery

August 13, 2020, Deadline for Healthcare Providers and Life Sciences Federal Contractors: Ban on Use of Certain Chinese...

McDermott Will & Emery on

Effective August 13, 2020, an Interim Rule jointly issued by the Department of Defense (DoD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) that amends the Federal...more

Mintz

Medical Device Updates: U.S. Food and Drug Administration (FDA) Practice Trends

Mintz on

Data and Analytics — FDA’s Post-market Surveillance Data Proposals Press Forward - FDA’s National Evaluation System for Health Technology, or NEST, as FDA calls it, is quickly gaining traction as one of the...more

King & Spalding

EU Law Making Bodies Entered into an Agreement on the New EU Medical Devices Regulations on May 25, 2016

King & Spalding on

On May 25, 2016, the European Parliament, European Council and the European Commission agreed on new rules regarding the approval and surveillance of medical devices and in vitro diagnostics for the European market. The...more

Faegre Drinker Biddle & Reath LLP

Judge Dismisses FDA Spying Case But Not Because It’s Innocent

Faegre Drinker Biddle & Reath LLP on

Earlier this week a federal judge dismissed a lawsuit by six former and current FDA scientists who allege that the FDA retaliated and spied on them for blowing the whistle on FDA approval of medical devices that put cancer...more

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