|
 
Today, the U.S. Food and Drug Administration (FDA) issued the final guidance Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers to help manufacturers understand and participate inthe VMSR program. The guidance intends to further explain, but not change, the conditions of the VMSR program.
The FDA has also updated information about the VMSR Program to reflect the final guidance.
Facts about the final guidance
This final guidance:
- Helps the public understand the program criteria, including the conditions under which manufacturers may submit certain malfunction reports to the FDA in summary format.
- Describes the conditions of when individual malfunction reports may be required—instead of summary reports—for devices that are ineligible for the program, such as when individual reports are necessary to address a public health issue.
- Allows the public to identify malfunction trends more readily and reduces the burden on manufacturers.
Questions?
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
|
|
|
|
