Topic Archives: Drug & Medical Device

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.” This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program. In conjunction with the end of the program, FDA also published ...›

Gavel

Leave Arbitration to the Arbitrator: No “Wholly Groundless” Exception Where Contract Delegates Arbitrability Determination to the Arbitrator

The United States Supreme Court continued the pro-arbitration trend in its jurisprudence, as well as its strict construction of the Federal Arbitration Act, in its unanimous decision in Henry Schein, Inc. v. Archer & White Sales, Inc., No. 17-1272, 2019 WL 122164 (U.S. Jan. 8, 2019).  Resolving a division in the Circuits on the issue, ...›

FDA Announces New Efforts to Combat Cybersecurity Threats in Medical Devices

FDA is tackling cybersecurity threats head-on and expects industry to do the same.  Earlier this month, FDA commissioner Scott Gottlieb, M.D., announced a series of developments designed to keep pace with evolving cybersecurity threats to medical devices.  Industry should take note, as these developments detail the agency’s current expectations for companies preparing to combat future ...›

June 13, 2018Drug & Medical Device, Privacy

A New Era in FTC Data Security Oversight?

The U.S. Court of Appeals for the Eleventh Circuit has issued a ruling that may drastically change the nature of the relief that the Federal Trade Commission (“FTC”) seeks to impose on companies it alleges to have had inadequate data security measures in place. Specifically, on June 6, 2018, the Court issued a long-awaited decision ...›

3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices.  The guidance represents FDA’s efforts to provide regulatory direction about additive manufacturing (AM)—the broad field of 3D printing—of medical devices.  Specifically, AM makes objects by sequentially building 2-dimensional layers and joining each to the layer below.  ...›

October 24, 2017Drug & Medical Device, FDA

Understanding FDA Guidance On Connected Medical Devices

In the coming years, we expect to see an explosion in the number of interoperable medical devices. These are connected medical devices that have the ability to connect to different technologies and devices, even from other manufacturers. The U.S. Food and Drug Administration also recognizes the growing importance of these connected devices and issued final ...›

Pharma

Bristol-Myers Squibb: The Aftermath

Last month, the U.S. Supreme Court clarified the scope of specific personal jurisdiction in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty., 137 S. Ct. 1773 (2017) (“BMS”). Mass tort defendants have wasted little time in moving to dispose of claims from nonresident plaintiffs under this ruling. As previously reported, on June 19, 2017, the ...›

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a citizen’s petition calling for the same warnings.  Cerveny v. Aventis, Inc., No. 16-4050 (10th Cir. May 2, 2017). ...›