George Gibeily, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Start Further Info FOR FURTHER INFORMATION CONTACT: As part of this reclassification, FDA is also amending 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. FDA is issuing this reclassification on its own initiative based on new information. FDA is identifying the 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.
#Remove astriks final draft 10 code
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify surgical staplers for internal use (formerly 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. Provide legal notice to the public or judicial notice to the courts.įood and Drug Administration, HHS. Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of
#Remove astriks final draft 10 pdf
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