FDA Draft Guidance on Analytical Chemistry Testing for Medical Device Biocompatibility: Key Recommendations and Public Comment Deadline

The Draft Guidance provides recommendations for analytical chemistry testing to evaluate the biocompatibility of medical devices. Key aspects include:

• Topics Covered:
  
  – Molecular formula generation
  – RT matching
  – Detection methods
  – Calibration, sensitivity, and quantification methods
  
•  Public Comment Deadline: 18-Nov-2024
• Information Gathering: Steps for device components and materials are outlined, with tentative identifications to be reported.
• FDA Feedback: The Q-submission process allows for obtaining FDA feedback on study design.
• Standards: General principles for analytical chemistry testing per ISO 10993-18 are recommended.

Source:https://www.fda.gov/media/181952/download
Region: United States of America