Requirements · Healthcare
FDA medical device reporting (21 CFR Part 803)
Medical device reporting for user facilities. 2 Moraph products list it under “Requirements it supports”. The products support this requirement; meeting it remains your organization’s responsibility.
About the rule
What it is
21 CFR Part 803 is the US Food and Drug Administration’s medical device reporting regulation. It requires device user facilities, such as hospitals and nursing homes, to report device-related deaths to the FDA and the manufacturer, and device-related serious injuries to the manufacturer, and it sets reporting duties for manufacturers and importers.
Source: 21 CFR Part 803 (eCFR). This summary is for orientation only; read the rule itself or ask your counsel for what it requires of you.
Citations
How the products cite it
The exact wording on the product pages, with how many products use each.
- FDA Medical Device Reporting, user facility requirements (21 CFR Part 803) 1 product
- FDA medical device reporting for user facilities (21 CFR Part 803) 1 product
For what it requires of your organization, read the rule itself or ask your counsel.
Products
The 2 products that support it
Implant & Tissue Compliance Tracker
Barcode tracking of biological implants and tissue from receipt to patient to help manage FDA recalls and expiration. Use and reporting decisions remain your staff's.
Lists:
- FDA Medical Device Reporting, user facility requirements (21 CFR Part 803)
IT Service Management
Specialized workflows for Clinical Engineering (e.g., "MRI in Room 4 is down").
Lists:
- FDA medical device reporting for user facilities (21 CFR Part 803)
Not sure which requirements apply to you? Request a gap analysis. All requirements: Requirements our products support.