errors (28.8%) or device design issues (28.4%). Materials and component issues (16.3%) and change control processes (11.9%) account for the majority of the remaining 510(k) recalls.

  1. Compared to 510(k)s unaffected by recall, recalled 510(k)s are more likely to have been reviewed by a third party or submitted as a Special application (rather than Traditional or Abbreviated). Recalls are also more likely to affect 510(k)s involving life sustaining devices and Class III devices.

OVERVIEW OF 510(k) PREMARKET NOTIFICATION PROGRAM AND FDA RECALLS

The 510(k) process requires a device manufacturer to notify FDA before it intends to market a device and to establish that the device is “substantially equivalent” to a legally marketed “predicate” device that does not require a PMA.1

One measure of the success of the 510(k) premarket notification process would be to assess the performance and reliability of the thousands of individual devices that have been cleared via this pathway. This is both impractical and impossible. Recalls and Medical Device Reports represent surrogate markers of device reliability.

A recall is an action taken to address a problem with a medical device that violates FDA law.2 Recalls occur when a medical device is defective and/or when it could be a risk to health. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority. Importantly, recalls may be issued when there is only a small chance (sometimes <1%) of device malfunction or patient injury. Recalls are classified by FDA as follows:

  • Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

  • Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

  • Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

1

Government Accountability Office. Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved Through the Most Stringent Premarket Review Process. January 2009. Accessed June 16, 2009 at http://www.gao.gov/new.items/d09190.pdf.

2

U.S. Food and Drug Administration. Recalls, Market Withdrawals, and Safety Alerts. Accessed at http://www.fda.gov/Safety/Recalls/ucm165546.htm.



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