After obtaining FDA certification (clearance) for a Class II medical device, manufacturers must continue to comply with various regulations and fulfill certain requirements to maintain regulatory compliance, ensure ongoing device safety and effectiveness, and facilitate post-market surveillance. Here are the key regulations and requirements to consider:

Post-Certification Regulations and Requirements:

1. Quality System Regulation (QSR):

   • Requirement: Continue to comply with FDA's Quality System Regulation (21 CFR Part 820).
   • Purpose: Ensure that manufacturing processes, quality control, and post-market surveillance activities maintain consistency and adhere to FDA standards.
   • Actions: Conduct regular audits, maintain documentation of processes and procedures, and implement corrective and preventive actions as necessary.

2. Labeling and Advertising:

   • Requirement: Ensure that device labeling (21 CFR Part 801) and advertising (21 CFR Part 807) comply with FDA regulations.
   • Content: Labels must accurately reflect the device's intended use, include required warnings, precautions, and instructions for use. Advertising materials must not be misleading and should accurately represent the device's capabilities and limitations.

3. Post-Market Surveillance:

   • Requirement: Implement a post-market surveillance system to monitor device performance, detect potential safety issues, and collect data on adverse events.
   • Actions: Monitor complaints, adverse event reports, and other post-market data. Report adverse events to the FDA as required (21 CFR Part 803) and maintain records of complaints and investigations.

4. Medical Device Reporting (MDR):

   • Requirement: Comply with FDA regulations on Medical Device Reporting (21 CFR Part 803).
   • Reporting: Report adverse events, device malfunctions, and serious injuries related to your device to the FDA within specified timeframes. Maintain records of MDR events and investigations.

5. Unique Device Identification (UDI):

   • Requirement: Ensure that your device is properly identified with a Unique Device Identifier (UDI) as per FDA regulations (21 CFR Part 830).
   • Compliance: Submit device information to the FDA's Global Unique Device Identification Database (GUDID) if required. Ensure that UDI labeling is accurate and compliant.

6. Changes and Modifications:

   • Requirement: Submit a new 510(k) or premarket approval (PMA) supplement for significant changes to the device that could affect safety or effectiveness.
   • FDA Review: Obtain FDA review and clearance for modifications that require submission of additional data or information beyond the scope of the original clearance.

7. Inspections and Audits:

   • Requirement: Be prepared for FDA inspections to assess compliance with regulatory requirements, including QSR, post-market surveillance, and MDR.
   • Actions: Maintain readiness for inspections, cooperate with FDA investigators, and address any findings or observations promptly.

8. Annual Reporting:

   • Requirement: Some devices may require annual reporting to the FDA to update on device performance, changes made, and any new safety or effectiveness data.
   • Compliance: Submit required reports within specified timelines, detailing any updates or changes since the last submission.

Contact Us：

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