The FDA has granted several exemptions to its Medical Device Reporting requirements related to events identified in certain real-world data sources, such as medical device registries.
The medical device reports describe both patient infections and other possible contamination issues.
The agency anticipates the program will result in a two-thirds reduction of the amount of device malfunction reports submitted by manufacturers.
When it comes to adverse event reporting, the FDA does not grant exemptions.
How in touch are you with current MDR guidelines?
If your firm does not have an MDR procedure, FDA will find out.
Never downplay the importance of customer complaints.
The document clarifies the MDR regulation and reporting requirements for medical device companies.
Define, document and implement!
Are you UDI-ready? Get the facts to achieve compliance fast.