Medical Device Reporting. FDA CFR Title 210 Part 820.
Information & Training. | Medical Devices.Medical Device Reporting (MDR) is a post-market surveillance process applied by the FDA to monitor medical device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of medical device products.
Mandatory reporters (i.e. manufacturers, device user facilities, and importers) are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices.
In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.
What is a Malfunction and when must a Medical Device Malfunction be reported?“Malfunction” means the failure of a device to meet its performance specifications or otherwise perform as intended [21 CFR 803.3]. Performance specifications include all claims made in the labeling for the device.
Mandatory Reporting for Manufacturers, Importers and Device User Facilities (Form FDA 3500A):Find information and instructions for mandatory device reporting at:
Reporting Medical Device Adverse Events for Manufacturers, Importers and Device User Facilities
Instructions on Voluntary Malfunction Summary Reporting Program
Instructions for Completing Form FDA 3500A
eMDR – Electronic Medical Device Reporting
Medical Device Reporting for Manufacturers – Guidance for Industry and Food and Drug Administration Staff
FDA Guidance: Medical Device Reporting for User Facilities (PDF Only) (PDF – 313KB)
Searching Medical Device ReportsThe Manufacturer and User Facility Device Experience (MAUDE) database contains mandatory reports filed by manufacturers and importers from August 1996 to present, all mandatory user facility reports from 1991 to present, and voluntary reports filed after June 1993. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources.
Information & Training.
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
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