PMA Posts

PMA Submission Helps Medtronic Win Lawsuit

Mark Crawford

After a five-day bench trial in February, Judge Mark Davis, U.S. District Court-Eastern Virginia, rejected a lawsuit brought by W.L. Gore & Associates against Medtronic. Gore claimed that Medtronic violated a patent it holds on the manufacturing process for making intraluminal stent grafts used for treating aneurysms. (more…)

FDA Proposes Guidelines for Improving Representation of Women in Clinical Studies

Mark Crawford

On December 19 the FDA released a new draft guidance recommending improvements to medical device manufacturers’ clinical study designs that do a better job of evaluating the effectiveness of their products for women. The draft guidance can be read at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm283453.htm.

Entitled “Draft Guidance for Industry and Food and Drug Administration Staff Evaluation of Sex Differences in Medical Device Clinical Studies,” the document aims to correct the historic underrepresentation of women in clinical studies. A 2001 report by the U.S. Government Accountability Office (GAO) on FDA-reviewed drug studies found that while women represented 52 percent of study enrollees, 30 percent of study documents did not report outcomes by sex and nearly 40 percent did not report enrollment demographics. A 2009 study of cardiovascular device pre-market applications showed that pivotal studies that reported sex enrolled an average of 33.9 percent women. (more…)

Will the Medical Device Regulatory Improvement Act Be a Game-Changer?

Mark Crawford

Three years ago the FDA enacted tougher measures to reduce the potential conflicts of interest for medical device experts advising the U.S. Food and Drug Administration (FDA).

Claiming that these rules are strangling the timely advance of new medical devices to the market, U.S. Senators Amy Klobuchar (D-Minnesota), Richard Burr (R-North Carolina), and Michael Bennet (D-Colorado) have introduced the “Medical Device Regulatory Improvement Act” in an effort to streamline the FDA regulatory process. (more…)