For FDA certification of Class II medical devices, the following systems and requirements are typically necessary:

1. Quality Management System (QMS):

   • You must establish a Quality Management System (QMS) that complies with FDA's Good Manufacturing Practices (GMP), also known as Quality System Regulations (QSR) under 21 CFR Part 820.
   • This system ensures that your devices are consistently manufactured to meet regulatory standards and specifications.

2. Design Controls:

   • A critical part of the QMS is implementing design controls for medical device development, as required under 21 CFR Part 820.30. This involves systematic processes to ensure your device is designed safely and effectively before entering the market.

3. Risk Management System:

   • A risk management process, typically aligned with ISO 14971, is necessary to assess and mitigate potential risks associated with your device. This includes identifying hazards, evaluating risks, and defining actions to reduce or control them.

4. Clinical and Non-Clinical Testing:

   • For many Class II devices, you'll need to conduct both clinical and non-clinical testing to demonstrate safety and efficacy. This may involve bench testing, biocompatibility testing, or, in some cases, clinical trials.
   • Documentation of these tests must be included in the 510(k) submission to the FDA.

5. Labeling System:

   • Your labeling must comply with FDA regulations, including proper instructions for use, warnings, and claims. This includes ensuring that your labeling does not mislead or provide incomplete information about the device.

6. Post-Market Surveillance:

   • After the device is cleared by the FDA, a system for post-market surveillance is necessary. This includes monitoring the device's performance in the field, reporting adverse events, and conducting recalls if necessary.
   • FDA regulations such as Medical Device Reporting (MDR) (21 CFR Part 803) and Post-Market Surveillance (21 CFR Part 822) apply.

7. Establishment Registration and Device Listing:

   • You must register your manufacturing facility with the FDA and list your device on the FDA’s Device Registration and Listing system. This ensures that your device is recognized as legally marketed in the U.S.

In summary, a comprehensive system involving quality management, risk assessment, testing, and post-market monitoring is required to meet FDA standards for Class II medical devices.

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