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WuXi AppTec MD_CN's Biocompatibility Lab is FDA-ASCA accredited

2023-06-01

WuXi AppTec China Medical Device Testing Center is the only one lab that is ASCA-accredited for biocompatibility to date (As of the date of this article) in Asia-Pacific area^【2】 Utilizing an ASCA-accredited testing lab provides confidence in the accuracy, reliability, and impartiality of the testing results, which is crucial for medical device companies' decision-making, regulatory compliance. Below are the background info relating to ASCA and advantages of choosing ASCA test labs^【1】^【3】. 01、Background FDA has implemented the ASCA Pilot in accordance with: ASCA is a "Conformity Assessment and Accreditation Program" project implemented by the FDA in accordance with the 2017 revision of Article 514 of the "Federal Food, Drug and Cosmetic Act" and the "Medical Device User Fee Amendment" promulgated in 2017. Improve FDA's confidence in medical device testing during product review to reduce regulatory burdens and ensure safe, effective, and high-quality medical devices for patients ^【1】. 02、Goals The voluntary ASCA Pilot is an accreditation scheme that capitalizes upon the increasingly prominent role that standards play in regulatory science and practice. The ASCA Pilot goals are to ^【1】: NO.1 Streamline conformity assessment in device submissions NO.2 Enhance the FDA’s confidence in test methods and results NO.3 Decrease the need for additional information related to conformance with a standard NO.4 Promote consistency, predictability, and efficiency in medical device review NO.5 Serve as a least burdensome approach to conformity assessment 03、Advantages WuXi AppTec Medical Device Testing Center biocompatibility laboratory technical leader said the advantages of choosing testing done at an ASCA-accredited testing lab are： Credibility and Trust: ASCA accreditation signifies that the testing lab has undergone a rigorous assessment process to demonstrate its competence, impartiality, and compliance with internationally recognized standards. This accreditation enhances the credibility and trustworthiness of the testing lab's results and reports. Compliance with Standards: ASCA-accredited testing labs adhere to relevant ISO/IEC standards, ensuring that their testing methods, procedures, and equipment meet internationally accepted criteria. This compliance helps ensure accurate and reliable test results that can be compared and understood universally. Competence and Expertise: ASCA accreditation requires testing labs to demonstrate their technical competence in conducting specific types of tests. Accredited labs employ highly trained and experienced professionals who specialize in biocompatibility testing. These experts have in-depth knowledge of relevant standards, regulations, and testing methodologies. Their expertise ensures that the testing is conducted using appropriate protocols, leading to more reliable and accurate results. Impartiality and Objectivity: ASCA accreditation requires testing labs to demonstrate impartiality and objectivity in their operations. This means that they conduct tests without any undue influence or conflicts of interest, ensuring the integrity and fairness of the testing process. Compliance with Regulatory Requirements: Many industries and regulatory authorities require testing to be performed by accredited labs. Choosing an ASCA-accredited lab ensures that your testing activities comply with regulatory expectations and can help streamline regulatory submissions and approvals. International Recognition: The ASCA accreditation program is a laboratory accreditation based on ISO/IEC 17025 accreditation and compliance with FDA GLP (21 CFR 58) requirements, so choosing an ASCA-accredited laboratory is especially beneficial for medical device manufacturers participating in international trade , help to improve the acceptance of its test reports in different countries and regions.Many industries, sectors, and regulatory bodies require testing to be conducted by accredited laboratories. By choosing an ASCA-accredited lab, organizations can fulfill these requirements and gain wider market access for their products or services. Accreditation can facilitate global trade. Continuous Improvement: Accredited labs undergo regular assessments and surveillance audits to maintain their accreditation status. This ongoing monitoring promotes continuous improvement, ensuring that the lab's operations remain up to date with the latest industry practices and standards. Consistency and Traceability: Accredited labs follow standardized testing methodologies and procedures, ensuring consistency in their results. This allows for easier comparison of test data over time or between different laboratories. Additionally, accredited labs have robust systems in place for traceability, ensuring that measurements and calibrations can be linked to national or international standards. Quality and Compliance: ASCA accreditation ensures that the testing lab meets stringent quality and performance standards. Accredited labs undergo regular assessments and inspections to ensure their compliance with recognized industry guidelines and efficient practices. This accreditation provides confidence in the reliability and accuracy of the testing results. The background of this article comes from: [1] FDA official website: https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/accreditation-scheme-conformity-assessment-asca. [2] FDA official website: https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/asca-accredited-testing-laboratories. [3] The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.

ISO 10993-23 new method of biocompatibility stimulation test - in vitro stimulation test

2021-08-17

In January 2021, the international organization for standardization issued the new standard ISO 10993-23 for stimulation test, which enriched and optimized the chapters of alternative methods for stimulation test in vitro on the basis of ISO 10993-10. Stimulation test is a routine test of biocompatibility test of medical devices. Stimulation test of medical devices, medical device components or biomaterials can be carried out by devices, device components, biomaterials themselves or their extracts. Guinea pigs and rabbits are typical animal models. Generally, it is carried out by intradermal injection or surface application. The skin condition of animals is the key factor of the test. Only animals with healthy skin and no damage can be used. It is recommended to observe the skin reaction under natural light or full spectrum light, and judge the irritation according to the score of skin erythema, eschar and edema. Any material that has been identified as skin, eye and mucosal tissue irritants, or materials with pH ≤ 2.0 or ≥ 11.5, shall not be subject to stimulation test. If further risk characterization / assessment is required, in exceptional cases, even if it is known that the tested material is an irritant or the pH of the material is outside the above range, it may still need to be tested, which shall be demonstrated and documented.