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Medical Devices › Standard of Review

Morrison & Foerster LLP - Left Coast Appeals

This Week at the Ninth: Biomaterials and Unclean Hands

Morrison & Foerster LLP - Left Coast Appeals on

This week, we take a look at the Ninth Circuit’s decisions construing the Biomaterials Access Assurance Act’s immunity for “biomaterials suppliers” and addressing the standard of review when a district court grants summary...more

Hogan Lovells

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization

Hogan Lovells on

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to...more

Hogan Lovells

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Hogan Lovells on

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more

Hogan Lovells

FDA proposes rule to codify existing guidance on supervisory review of CDRH decisions

Hogan Lovells on

On January 17, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule to update the framework for requesting internal agency supervisory review of certain decisions related to devices regulated...more

Mintz - Health Care Viewpoints

FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality

Mintz - Health Care Viewpoints on

This is the third installment of our year-in-review series covering major developments at FDA.  While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more

Knobbe Martens

Supreme Court Makes it Easier for Medical Device Companies to Recover Enhanced Damages for Patent Infringement

Knobbe Martens on

The Patent Act provides that, in a case of infringement, courts “may increase the damages up to three times the amount found or assessed.” Previously, in order to recover enhanced damages under the Patent Act, a patent owner...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

High Court Nixes Federal Circuit’s Indefiniteness Test

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

On June 2, 2014, the U.S. Supreme Court in Nautilus, Inc. v. Biosig Instrument, Inc., addressed the standard that Courts must use to determine whether a patent claim complies with 35 U. S. C. §112, ¶2. A patent “claim”...more

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