title: Median approval times for class III medical devices have been well above statutory deadlines set for FDA and CMS.
abstract: The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) play key roles in making safe and effective medical devices available to the public. Since 1997 Congress has passed "modernization" laws that specify statutory deadlines for these agencies to review manufacturers' applications for premarket approval--the process by which the FDA evaluates the safety and effectiveness of class III medical devices, those that pose the highest risk--and applications for national coverage by Medicare. We questioned whether these reforms shortened approval time at the FDA and CMS. We searched publicly available databases for information for the period from January 1, 1995, through December 31, 2008, and calculated median time to approval. After initially declining, the FDA median approval time increased after 2002 and nearly reached the 1997 prereform levels by the end of the study period. In contrast, the CMS median approval time decreased steadily over the period. Neither agency consistently met the statutory deadline of 180 days for approval of premarket applications or national coverage. Congress should consider the underlying causes for these delays in the development of future modernization legislation.
authors.affiliation: zinn802@sbcglobal.net
authors.forename: Annette M
authors.initials: AM
authors.lastname: Zinn
authors.forename: John C
authors.initials: JC
authors.lastname: Allen
authors.forename: Carl S
authors.initials: CS
authors.lastname: Hacker
mesh_terms: D014487:Centers for Medicare and Medicaid Services, U.S.; D016208:Databases, Factual; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000145:classification*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration