General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers
Information
Type
Proposed Rule
Regulated products
Published
April 24, 2019
Last updated
April 24, 2019
Description
Document number 2019-08260. The Food and Drug Administration (FDA or the Agency) is proposing to reclassify surgical staplers for internal use (currently regulated under the classification for "manual surgical instrument for general use" and assigned the product code GAG) from class I (general controls) into class II (special controls) and subject to premarket review. FDA is identifying the proposed special controls for surgical staplers for internal use that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. As part of this reclassification, FDA is also proposing to amend the existing classification for "manual surgical instrument for general use" to remove staplers and to create a separate classification regulation for surgical staplers that distinguishes between surgical staplers for internal use and external use.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)