Federal Preemption of Class III Medical Devices Receiving Premarket App

Federal Preemption of Class III Medical Devices receiving premarket approval Case in Review Court rulings have held that the preemption clause included in the Medical devices act of 1976 protects class III medical devices which have been approved through the Food and Drug Administration’s (FDA) premarket approval process (PMA) from litigation. Injured parties have no means to seek relief from device manufacturers for injuries sustained due to the use of a class III medical device receiving PMA. Overview of the FDA and Medical devices act of 1976: Congress created the Food and Drug Administration in 1938 under a statute known as the Federal Food, Drug and Cosmetic Act. Under the 1938 act, the FDA could not prevent medical devices from entering the market but they could remove unsafe devices from the marketplace. The FDA believed that those same powers given to regulation of drugs should be extended to medical devices to ensure public safety. The Medical devices act of 1976 granted oversight and approval of medical devices to the FDA as a logical extension of duties already provided under previous legislation. The act provided for three classes of medical devices, levels I, II and III. Devices classified under level III were given the most rigorous level of testing and review due to the fact that these devices could produce the greatest level of harm. Level III devices are the only class of devices that are subject to premarket approval which requires manufacturers to submit information related to the safety and effectiveness of their devices for FDA review and approval. The Medical devices act of 1976 included a preemption clause over state law to ensure the federal statutes held supremacy over any state statut... ...mble_fda_final_rule.php>. "Medical Devices." U S Food and Drug Administration Home Page. N.p., n.d. Web. 22 Apr. 2012. . Miller, Roger Leroy, and William Eric Hollowell. Business Law. Mason, OH: South Western Cengage Learning, 2011. Print. "The Development of the Medical Device Amendments | MDDI Medical Device and Diagnostic Industry News Products and Suppliers." MDDI Medical Device and Diagnostic Industry News Products and Suppliers. N.p., n.d. Web. 5 May 2012. . measure, the most plausible, [PDUFA] did not, and in. "Project FDA Report 1 | In the Wake of Wyeth v. Levine: Making the Case for FDA Preemption and Administrative Compensation." Manhattan Institute. N.p., n.d. Web. 21 Apr. 2012. .