FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Schedules Public Meeting on Reclassification of Surgical Staplers

April 29, 2019
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The FDA’s Medical Devices Advisory Committee panel on general and plastic surgery devices will meet on May 30-21, 2019 to discuss the reclassification of surgical stapler devices for internal use from Class I (general controls) to Class II (special controls).

On day-two of the public meeting, the committee will make recommendations on the reclassification of certain absorbable hemostatic agents from Class III to Class II (special controls).

The FDA issued an alert last month warning of the risks of surgical staplers for internal use and implantable surgical staples. The alert was prompted by a large number of medical device reports associated with the use of the devices.

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