The FDA is seeking public input on the proposed reclassification of surgical staplers for internal use from Class I (general controls) to Class II (special controls).
As announced in April, the FDA will hold an open public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee on May 30, 2019, from 9 a.m. to 4 p.m. in Gaithersburg, MD, to discuss the proposed reclassification of surgical staplers for internal use. (Note: The meeting time has changed from 10 a.m., as stated in theFederal Register notice, to 9 a.m. on May 30. The correct time will be published in an upcoming Federal Register notice.)
We invite any interested parties to participate in the public panel meeting and to submit comments on the proposed reclassification by the dates listed below:
- May 10: Request to make a formal oral presentation at the panel meeting
- May 20: Submit written comments to the panel
- May 30: Attend the panel meeting in Gaithersburg, MD
- June 24: Submit written comments on the proposed order to reclassify to docket FDA-2019-N-1250
The FDA intends to make background material available to the public no later than 2 business days before the panel meeting.
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