Managing Partner @ BDRA Consulting LLC| Regulatory Affairs and Quality Assurance
BDRA Consulting LLC has been a member of AMDM since 2013. Come join AMDM for the entire story. Twice a year, members get to meet with the FDA to discuss upcoming regulatory and quality policies. The FDA provides industry updates. This year's meeting was held at Building 66, White Oak campus on May 21, 2024. Key Takeaways from the May 2024 AMDM Industry FDA Roundtable: 1. Cybersecurity for medical devices is a key issue. OHT7 and CDRH have increased focus on cybersecurity for medical devices. 2. The Oncology Diagnostic Pilot Program is nearly a year old, and no company has been accepted. This is primarily because drug manufacturers have not been able to provide validation data. 3. Reclassification plans for companion diagnostics are ongoing and will be completed by November 2027. - FDA is considering down-classifying three types of CDxʼs: i. Nucleic acid-based CDX ii. In situ hybridization-based CDX iii. Immuno-histochemistry-based CDX - Technologies will be grouped based on the intended use. 4. PCCP guidance for medical devices will be published before the end of the fiscal year 2024. A PCCP may be used to make changes to sample type changes, which may be acceptable in certain cases. 5. QSIT is being replaced by an entirely novel risk-based approach, which is currently being worked out. Manufacturers should be working through transition plans. #AMDM
