For Class III medical devices seeking FDA certification (clearance or approval), adherence to recognized standards is crucial to demonstrate compliance with regulatory requirements and ensure device safety and effectiveness. Here are some key standards and guidelines relevant to Class III medical device FDA certification:

1. Quality System Regulation (QSR):

• FDA 21 CFR Part 820: Also known as the QSR or Current Good Manufacturing Practice (CGMP), these regulations set forth requirements for the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices.

2. Risk Management:

• ISO 14971: This international standard provides a framework for manufacturers to identify and manage risks associated with medical devices throughout their lifecycle. It is widely recognized and serves as a basis for risk management requirements.

3. Biocompatibility:

• ISO 10993: A series of standards for evaluating the biocompatibility of medical devices. Specific parts of ISO 10993 cover various aspects of biocompatibility testing, including cytotoxicity, sensitization, irritation or intracutaneous reactivity, and systemic toxicity.

4. Electrical Safety:

• IEC 60601 series: Standards for medical electrical equipment, covering safety and essential performance requirements. For Class III devices involving electrical components or operation, compliance with relevant parts of IEC 60601 may be necessary.

5. Software Validation:

• IEC 62304: A standard that defines lifecycle requirements for medical device software, including software development, maintenance, and risk management processes.

6. Clinical Evaluation:

• ISO 14155: This standard provides guidance on clinical investigations of medical devices for human subjects, ensuring that clinical data generated is reliable and meets regulatory requirements.

7. Packaging and Labeling:

• ISO 11607: Standards for packaging systems for terminally sterilized medical devices. Compliance ensures that device packaging maintains sterility and protects the device throughout its shelf life.

8. Performance Testing:

• ASTM F1980: Standard guide for accelerated aging of sterile medical device packages. This is used to determine shelf life and aging effects on medical device packages.

9. Sterilization:

• ISO 11135: Standards for ethylene oxide sterilization of medical devices. Compliance with sterilization standards ensures that devices are safe for patient use.

10. Clinical Data and Evaluation:

• FDA Guidance Documents: While not standards per se, FDA guidance documents provide recommendations and expectations for demonstrating the safety and effectiveness of medical devices through clinical data and evaluations.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn