Here are five takeaways:
1. The agency convened the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee on Feb. 26 to seek its opinion on how it should regular several groups of hemorrhoid treatment devices that have been approved for marketing but have not been classified in accordance with a 1976 law that governs medical devices.
2. The advisers agreed with the FDA that electrically powered heating devices for hemorrhoids are intermediate-risk devices, and thus should be considered class 2. The panel agreed manufacturers of those devices should demonstrate biocompatibility and conduct performance testing to show that maximum temperatures are not exceeded, and to verify mechanical integrity and electrical safety.
3. The advisory panel agreed with the FDA that cushions, plastic seats and other devices meant to alleviate the pressure on hemorrhoids while sitting could be given the lowest-risk determination (class 1). The advisory panel also agreed with the FDA that devices using liquid for heating or cooling to treat hemorrhoids could be regulated as class 1.
4. The FDA’s rules require that manufacturers of class 1 devices follow good manufacturing practices, keep good records and ensure the devices are not misbranded.
5. Class 2 devices typically must go through a 510(k) clearance process at the agency, and usually need additional measures of assurance that they are safe and more effective than what the FDA requires for the lowest-risk class 1 devices.
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