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FDA Seeks Comment on Class 1 Accessories

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.

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Comments on the FDA’s proposed classification of certain medical device accessories is due by mid-October.

Read the complete text of the FDA’s notification in connection with the classification of accessory devices.

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