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  • The Future of “Single Use Restrictions” in Jeopardy

    In 1992, the United States Court of Appeals for the Federal Circuit held that manufacturers of patented medical devices can use the patent laws to enforce single-use restrictions on medical devices.  Mallinckrodt, Inc. v. Medipart, Inc., 976 F.2d 700 (Fed. Cir. 1992).  The basic rationale of the decision was that a patent owner, when selling a patented product, may choose to part with all or onl ...
  • Certain Medical Devices Exempted from 510(k) Requirements

    The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements.  This publication was made by the FDA pursuant to the 21st Century Cures Act, signed into law on December 13, 2016. Premarket notification (510(k)) is one of several alternative procedures that medical device ...
  • FDA Approval for Medtronic’s Reveal LINQ ICM with TruRhythm Detection

    On March 13, 2017, Medtronic announced FDA 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection. Previously, Medtronic received Ministry of Health, Labor and Welfare approval for the device in Japan during September 2016, launching the product shortly after.  Medtronic now seeks to duplicate its successful launch in the United States. As shown on the ...
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