The U.S. Food and Drug Administration (FDA) is seeking public comment on a proposed list of medical device accessory products that it believes are suitable for Class I classification.
According to a Notification issued in mid-August, the FDA seeks to give eight different types of accessory devices Class 1 status, thereby exempting them from premarket approval requirements. The devices include accessories used in connection with urological biopsies and implanted urinary continence devices, air-handling apparatus, and devices use to introduce or connect binary stents, drains or dilators.
The FDA says that its proposal is based on its assessment of whether the accessory represents a potentially-unreasonable risk of illness or injury, and whether the agency’s provisions regarding general controls would be sufficient to provide reasonable assurances of the safety and effectiveness of the accessory.
Comments on the FDA’s proposed classification of certain medical device accessories is due by mid-October.
