켐론FDA코리아

FDA 의료 기기 승인신청을 위한 Q-Submission 프로그램에 관한 최종 지침.

FDA Issues Final Guidance on the Q-Submission Program for Medical Device Submissions

Today, the U.S. Food and Drug Administration (FDA) issued the final guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.The FDA’s Q-Submission Program provides submitters an opportunity to have early collaboration and discussions about medical device submissions.

This final guidance clarifies the available ways submitters can request feedback or a meeting with the FDA about potential or planned medical device or device-led combination product submissions. It also provides an opportunity for submitters to discuss issues communicated by the FDA during review of other submission types, such as submission hold letters.

On Tuesday, June 11, 2019, from 3:00 – 4:30 PM EST, the FDA will hold a webinar to provide additional information on this final guidance document and provide participants an opportunity to have questions answered by subject matter experts on this topic.

참조사이트 : https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program?utm_campaign=2019-05-06%20Guidance%20Webinar%20-%20Q-Submission%20Program%20for%20Medical%20Device%20Submissions&utm_medium=email&utm_source=Eloqua