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Report (OEI-04-10-00480)

09-19-2013
FDA's Clearance of Medical Devices Through the 510(k) Process

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Summary

WHY WE DID THIS STUDY

FDA's premarket notification (i.e., 510(k)) process is a faster and less stringent method to obtain clearance to market medical devices than the Premarket Approval (PMA) process. FDA is required to classify devices by the level of control needed to provide reasonable assurance of device safety and effectiveness (i.e., Class I, II, or III). Most Class III devices must be approved through the PMA process, although some continue to be cleared through the 510(k) process using regulatory categories of devices ("Class III preamendment device types"). The Safe Medical Devices Act of 1990 requires FDA to either reclassify Class III preamendment device types as Class II or I or keep them as Class III and require a PMA review.

HOW WE DID THIS STUDY

We determined whether FDA finished classifying the Class III preamendment device types used to clear devices through the 510(k) process, the number of Class III devices cleared using the 510(k) process, and the number of times each Class III preamendment device type was used to clear those devices through the 510(k) process from April 9, 2009, to July 9, 2012. We reviewed documents in files submitted to us electronically by FDA for Class III and Class II devices cleared through the 510(k) process in 2010. We did not determine whether FDA's clearance of the devices was appropriate.

WHAT WE FOUND

FDA has not finished classifying all types of Class III devices cleared through the 510(k) process, as required by Congress in 1990. As a result, FDA continues to clear some Class III devices through the 510(k) process. Additionally, FDA did not consistently document the review of Class III and Class II devices cleared through the 510(k) process in 2010, according to our review of the files provided electronically by FDA. Further, FDA did not provide complete administrative files during our data collection, thereby demonstrating deficiencies in its filing system.

WHAT WE RECOMMEND

FDA agreed with both of our recommendations to: (1) in accordance with the law, finish classifying all types of Class III preamendment devices used to clear devices through the 510(k) process and (2) improve its maintenance of administrative files for devices and continue to implement new policies on how to compile an administrative file.

Copies can also be obtained by contacting the Office of Public Affairs at Public.Affairs@oig.hhs.gov.

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