title: Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.
abstract: OBJECTIVE
  Postmarketing surveillance is critical to evaluating the safety and effectiveness of medical devices. The US Food and Drug Administration (FDA) may order the manufacturer of a high-risk device to conduct postmarketing surveillance studies, known as postapproval studies (PASs), at the time of approval.
  
  
  OBJECTIVE
  To understand the characteristics of PASs ordered in recent years and inform discussions about the direction of the PASs program.
  
  
  METHODS
  Descriptive study of the PASs ordered for medical devices using the FDA's PASs website, the Premarket Approval database, and supplemental information provided by the FDA.
  
  
  METHODS
  The proportion of medical devices that received a PAS order and study characteristics.
  
  
  RESULTS
  Between January 1, 2005, and December 31, 2011, the FDA ordered 223 studies of 158 medical devices, including studies for 93 (48%) new high-risk devices approved during this period. The median required sample size for a study was 350 patients (interquartile range, 160-1500). If the protocol of a study was not in place at the time the device was approved, which occurred frequently, a median of 180 days elapsed until the protocol was agreed on. The FDA has never issued a warning letter or penalty owing to study delays, inadequate progress, or any other issue related to a PAS. Of the approved protocols, 41 (19%) were subsequently revised, including 29 (21%) protocols in place by application approval. Some studies generated significant clinical findings. The most common effect of a PAS finding after study completion was that the FDA requested a labeling change for 31 studies (53%).
  
  
  CONCLUSIONS
  Postapproval studies have the potential to provide additional information to better understand medical device performance. However, small sample sizes, delays in reaching protocol agreement, and lack of availability of findings may hinder their ability to be clinically useful. Owing to the lack of information on the effect of studies, it is unclear whether the program achieves its aims. Improved completion and accessibility of PASs could help answer important questions of safety and effectiveness about medical devices. To better understand the real-world performance of these products, they should be better integrated with other sources of information about device performance.
authors.affiliation: The Pew Charitable Trusts, Washington, DC.
authors.forename: Ian S
authors.initials: IS
authors.lastname: Reynolds
authors.affiliation: The Pew Charitable Trusts, Washington, DC.
authors.forename: Joshua P
authors.initials: JP
authors.lastname: Rising
authors.affiliation: The Pew Charitable Trusts, Washington, DC.
authors.forename: Allan J
authors.initials: AJ
authors.lastname: Coukell
authors.affiliation: The Pew Charitable Trusts, Washington, DC2Pfizer, Silver Spring, Maryland.
authors.forename: Kirsten H
authors.initials: KH
authors.lastname: Paulson
authors.affiliation: Division of Cardiology, University of California San Francisco School of Medicine, San Francisco, California4Editor, JAMA Internal Medicine, San Francisco, California.
authors.forename: Rita F
authors.initials: RF
authors.lastname: Redberg
mesh_terms: D022126:Access to Information; D018795:Device Approval; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment; D014481:United States