
01-11
2024
Use of RWE to Support Regulatory Decision-Making for MD

01-11
2024
MDCG 2019-7-Rev.1 Guidance on article 15 of the MDR and IVDR

01-11
2024
510(k) Third Party Review Program 2 and Third Party EUA Review

01-11
2024
A Guide for Cybersecurity Regulations for MD Manufacturers

01-11
2024
MDCG 2021-6 Rev. 1– Q&A regarding clinical investigation

01-11
2024
Study supporting the monitoring of availability of MD

01-11
2024
Webinar - Oncology Drug Products Used with Certain IVD Tests

01-11
2024
MDCG 2022-11-Rev.1 MDCG Position Paper

01-11
2024
FDA-2023-N-3392 Proposed Rule

01-11
2024
Assessing the CM&S in Medical Device Submissions
