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FDA-APPROVED PRODUCTS WOULD BE SHIELDED FROM LIABILITY UNDER HOUSE MEDICARE BILL; BIOMATERIALS LIABILITY PROTECTION, BREAST IMPLANT CARVE-OUT EXCLUDED

This article was originally published in The Gray Sheet

Executive Summary

Health care liability language in the House Ways and Means/Health Subcommittee Medicare bill shields manufacturers from product liability claims if the product "was subject to premarket approval by [FDA] with respect to the safety of the formulation or performance" and when "such drug, device, packaging or labeling was approved by" the agency.

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