Description
Ensuring compliance with medical device vigilance reporting in the United States is critical for maintaining FDA approval and protecting patient safety. The U.S. Food and Drug Administration (FDA) enforces Medical Device Reporting (MDR) requirements under 21 CFR Part 803, requiring manufacturers, importers, and device user facilities to report adverse events, serious injuries, and malfunctions in a timely manner. Failure to comply can result in regulatory enforcement actions, product recalls, or market restrictions.
SOP-REG-007: Medical Device Vigilance Reporting in the United States provides a step-by-step framework to help manufacturers, importers, and healthcare facilities comply with FDA vigilance requirements. This SOP ensures full compliance with Medical Device Single Audit Program (MDSAP), ISO 13485:2016, and post-market surveillance (PMS) obligations, enabling businesses to minimize regulatory risk, streamline reporting processes, and maintain long-term compliance.
Compliance with FDA’s Medical Device Reporting (MDR) requirements is mandatory for all medical device companies selling products in the U.S. market. The MDR regulation (21 CFR Part 803) requires companies to systematically track, assess, and report adverse events, serious injuries, and device malfunctions. Non-compliance can lead to warning letters, product recalls, and loss of FDA approval.
SOP-REG-007: Medical Device Vigilance Reporting in the United States provides a structured regulatory approachto:
🔹 Determine whether an adverse event, injury, or device malfunction is reportable under FDA regulations.
🔹 Ensure timely submission of reports for serious incidents, including 30-day, 5-day, and supplemental reports.
🔹 Streamline compliance with FDA post-market surveillance (PMS) and recall management procedures.
🔹 Implement an effective internal process for managing complaints and documenting vigilance activities.
🔹 Maintain alignment with ISO 13485:2016 and MDSAP to simplify global compliance efforts.
This SOP is essential for Medical Device Manufacturers, Regulatory Affairs Professionals, Importers, Distributors, Healthcare Facilities, and Consultants looking for a cost-effective, structured approach to FDA vigilance reporting.
With SOP-REG-007, your business can eliminate reporting delays, avoid regulatory penalties, and enhance patient safety while maintaining full FDA compliance.
