Topic Archives: Drug & Medical Device

First Decisions Limit PREP Act Immunity in Coronavirus Context

When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act immunity in the COVID-19 setting have emphasized that the protection applies ...›

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Schein On: Supreme Court to Decide Key Arbitration Delegation Question

The Henry Schein arbitration battle is making its way to the Supreme Court again. The Court recently granted Henry Schein, Inc.’s certiorari petition to answer the question of “Whether a provision in an arbitration agreement that exempts certain claims from arbitration negates an otherwise clear and unmistakable delegation of questions of arbitrability to an arbitrator.” ...›

FDA Signals Flexibility with COVID-19 Tests

A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy. Consistent with this, FDA has taken various steps to accelerate the availability of testing, as we have previously reported. Notably, in its Policy ...›

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 ...›

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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.  ...›