NAMSA is a Medical Research Organization (MRO), accelerating product development

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1 NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA's MRO Approach plays an important role in translational research, applying a unique combination of disciplines consulting, preclinical, toxicology, microbiology, chemistry, clinical and quality to move client s products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world. FDA Guidance Panel 1

2 MEDICAL RESEARCH ORGANIZATION Panel Discussion on FDA Guidance: Use of ISO : Biological Evaluation of medical devices- Part 1: Evaluation and testing within a risk management process FDA Guidance Panel 2

3 Speakers Don Pohl Manager, Biological Safety & Validation Services Darin Kent, DABT Senior Medical Research Scientist, Toxicology Larry Johnson, DABT Principal Medical Research Scientist FDA Guidance Panel 3

4 Overview Guidance issued on June 16, 2016 FDA held webinar on the guidance on July 21, 2016 Supplemental Information Sheet for ISO updated on July 26, 2016 and now references new guidance as relevant guidance September 14, 2016: Supersedes Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, dated May 1, 1995 FDA Guidance Panel 4

5 Key Items Risk Assessment of the medical device - Materials - Manufacturing - Clinical use - Determine gaps in available information - Close gaps with testing or other evaluations - Conclude on safety of final finished device - Place at beginning of biocompatibility section in the submission as plan for addressing biocompatibility FDA Guidance Panel 5

6 Key Items Novel materials present potential risk depending on what is known - Defined in Attachment G: material not previously used in a legally US-marketed device - Concept developed in new flowchart in Attachment D - FDA recognizes that novel materials are not commonly used - Concept not elaborated on during the FDA webinar FDA Guidance Panel 6

7 Key Items Use of Threshold of Toxicological Concern (TTC) described for use in medical device evaluations - Described as a potential way to determine if identification of a chemical is needed if quantity known - Use in evaluating chemicals where a tolerable intake cannot be determined Chemical Characterization - Use mentioned for evaluation of some endpoints Systemic toxicity, genotoxicity, carcinogenicity, others - Emphasis on the use of characterization with risk assessment FDA Guidance Panel 7

8 Key Items Attachment A - Material mediated Pyrogenicity added as a biological effect Test specific items - Cytotoxicity 37 C for 24 to 72 hours - Hemocompatibility Complement activation limited to SC5b-9 in most cases - Genotoxicity Could be waived if chemical characterization of extracts indicates no risk of genotoxicity Known genotoxins may need chemical characterization to determine extent of release In vivo studies described as optional FDA Guidance Panel 8

9 Summary Final guidance represents a more complete perspective of evaluation as compared to G95 memorandum Touched on some key highlights Concepts have been in use by some and may not seem that different from current state Guidance emphasizes use of risk assessment to develop plans for addressing biological safety Risk assessment becomes the justification and definition of the biological evaluation FDA Guidance Panel 9

10 Questions? 10 FDA Guidance Panel 10

11 Thank you NAMSA Headquarters 6750 Wales Road Northwood, OH USA Telephone: For more information, please contact NAMSA (toll free) (outside of USA) (fax) 11 FDA Guidance Panel 11