FDA Panel Catches Up on Medical Device Classifications

Larry Hand

August 01, 2014

The Gastroenterology and Urology Devices Panel of the US Food and Drug Administration's (FDA's) Medical Devices Advisory Committee deliberated yesterday on the classification of 4 categories of medical devices that have so far been unclassified.

In a nonvoting session, panel members generally agreed with FDA staff members on how to classify penile erection evaluation devices, electrical stimulators for sperm collection, alloplastic spermatoceles, and nephrostomy catheters.

The devices were commercialized before the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetics Act, and they were unclassified as to regulatory type. The amendments provided 3 regulatory classifications based on the level of control (least to highest) needed for reasonable assurance of safety and effectiveness: class 1, class 2, and class 3.

Class 1 controls include good manufacturing practices, registration of manufacturing facilities, and recordkeeping. Class 2 controls include performance standards, postmarket surveillance, patient registries, and dissemination of guidelines, as well as premarket notification to FDA. Premarket FDA approval also is required for class 3, which includes life-sustaining or life-supporting devices.

For penile erection evaluation devices, the FDA staff recommended mitigation measures for identified risks associated with devices such as disposable penile blood pressure cuffs and urolab specimens. The risks included adverse tissue reaction to a device, for which preclinical biocompatibility testing and proper warning labels were recommended as mitigation measures. The FDA also recommended that these penile erection function devices be regulated as class 2 devices.

For electrical stimulators for sperm collection, the FDA staff recommended mitigation measures for identified risk associated with a rectal probe indicated for the treatment of infertility in men. Risks include local burns or other tissue damage, for which performance testing and proper warning labels were recommended as mitigation measures. These devices also were recommended for class 2 regulation.

For alloplastic spermatoceles devices, used for collecting semen through various methods for uses such as artificial insemination, the FDA staff identified risks including tissue injury resulting from aspiration error, for which performance test (bench and in vivo) and proper warning labels were recommended as mitigation measures. These too were recommended as part of the class 2 regulation.

For nephrostomy catheters, the FDA staff identified local tissue injury resulting from incorrect placement or postplacement migration as among the risks for which performance testing (bench) and proper warning labels were recommended as mitigation measures. For this device category, the FDA recommended splitting regulation into class 2 for catheters and class 1 for accessories such as guidewires and sheaths.

Advisory panel members generally agreed with all recommendations. The panel's recommendations will now be published, and after a public comment period, the FDA will develop a final rule on these classifications.

The advisory committee members have disclosed no relevant financial interests.

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