The manufacturer shall establish, document and maintain procedures for the issue of advisorynotices for medical devices. These procedures shall be capable of being implemented at any time.
制造业者应建立、书面化与维持发布医疗器材说明事项之程序，此程序应可随时执行。
2
Two related Federal Register notices are being published, one announcing the establishment of the new advisory committee and the other requesting nominations for members to serve on the committee.