인허가/FDA2 Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - FDA 가이던스에 대하여 part 1 Q-Submission FDA 가이던스입니다. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program 본 Q-Submission 가이던스는 23년도 6월에 갱신된 것으로 보입니다. (추가 갱신되더라도 본 글은 2023.06 기준임을 양해바랍니다.) 먼저 가이던스 목차를 살펴보면, 다음과 같습니다. Table of Contents I. Introduction II. Background III. Scope A. Pre-Submissions (Pre-Subs) B. Submission Issue Requests (SIRs) C. Study Risk Determinations D. Informationa.. 2023. 7. 28. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions 가이던스에 대하여 * 본 글은 FDA 의 Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions 가이던스를 참고하여 작성되었습니다. (* This post is written with reference to the FDA's Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Soft.. 2023. 7. 26. 이전 1 다음 반응형
