Module 14 2022

22/03/2022

Use of device materials for drug delivery

EXAMPLE - TREATMENT OF LIVER CANCER • Embolisation with device beads

• Chemoembolisation beads+chemotherapy

Masterclass Lecture 3

The Organisation for Professionals in Regulatory Affairs

31

Suggested further reading ● Cambridge Consultants: Good Design Practice for medical devices and equipment2 (available online) ● Davis JR, Handbook of Materials for Medical Devices, Publ ASM, 2003 • EU SCENIHR; Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices2015 http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o _045.pdf ● ISO 10993 – Biological evaluation of medical devices; in particular parts 1, 6, 7, 9 and 12-19. ● USFDA: https://www.fda.gov/science-research/nanotechnology- programs-fda/nanotechnology-guidance-documents

© TOPRA and Dr Helen Erwood ESPL Regulatory Consulting

The Organisation for Professionals in Regulatory Affairs

32

16