Tests Required for Sutures — FDA 510(k)

Biocompatibility tests are mandatory sections in an FDA 510 (k) submission for sutures; in most cases, these tests are conducted in a third-party lab. Besides biocompatibility testing, physical testing is also required in a 510 (k) notification, and test results must comply with approved standards like ASTM and ISO.

Suture 510k – Test Requirements.

• Skin sensitization test in guinea pigs (ISO 10993-10).
• Intracutaneous reactivity test (ISO 10993-23).
• Muscle implantation (70-days) test (ISO 10993-6).
• In vitro cytotoxicity (ISO 10993-5).
• Acute systemic toxicity test (ISO 10993-11).
• Bacterial Endotoxin Test or LAL test.
• Pyrogenicity.
• Subacute/Subchronic toxicity.
• Genotoxicity.
• Chronic toxicity.
• Carcinogenicity.
• Reproductive and developmental toxicity.
• Haemocompatibility.
• Degradation.

These are not a complete list of tests required for suture 510k submission; the requirements may change. Please verify with the latest FDA guidelines for updated requirements.

LMG Provides assistance to suture manufacturers in FDA registration, 510k clearance, device listing, and US FDA Agent requirements. Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

• Prepare 510k notification
• Submission of 510k notification
• FDA Agent service for 510k submission
• Guidance in test requirements
• Register your medical device establishment with FDA
• List your suture with FDA.