News & Analysis as of

Medical Devices › Pharmaceutical Industry › Deregulation

Hogan Lovells

FDA loosens restrictions on gynecologic power morcellators, recommends use only with containment

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an update to safety communications...more

Patrick Malone & Associates P.C. | DC Injury...

A clarion call for real safeguards for patients harmed by medical devices

Patrick Malone & Associates P.C. | DC Injury... on

Medical devices race onto the market with little or no effective testing or regulatory safeguards, and a proposed “reform” of the oversight system of products that are implanted in tens of millions of Americans is a sham,...more

Polsinelli

FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend

Polsinelli on

The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more

Patrick Malone & Associates P.C. | DC Injury...

Don’t give medical device makers more time before disclosing product woes

Patrick Malone & Associates P.C. | DC Injury... on

Pro-business and anti-consumer lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed...more

Searcy Denney Scarola Barnhart & Shipley

Congressional Hypocrisy — Taking away your rights

Searcy Denney Scarola Barnhart & Shipley on

As a part of the recent speed racing bills through Congress, they have put up HR 1215. Quite erroneously, they have titled it: “Protecting Access to Care Act of 2017”. A read of the act’s text quickly tells any objective...more

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