Laser Maker Can’t Escape FDA Through Private Club, 8th Circuit Rules

(August 25, 2015, 2:25 PM EDT) -- ST. LOUIS — The seller of purportedly therapeutic lasers cannot escape regulation by the Food and Drug Administration by distributing them in noncommercial transactions through private membership associations (PMA), a panel of the Eighth Circuit U.S. Court of Appeals ruled Aug. 21 (Dr. Larry Lytle v. United States Department of Health and Human Services, et al., No. 14-3715, United States of America v. 2035, Inc., et al., No. 15-1214, 8th Cir.; 2015 U.S. App. LEXIS 14686).

(Opinion available. Document #28-150903-009Z.)

However, the panel remanded a preliminary...
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