Devices

Malfunction Reporting Program Guidance

FDA has published a guidance, Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers, to help manufacturers better understand and use the program. The agency says the document is intended to further explain, but not change, the conditions of the VMSR program.

The guidance “describes and clarifies several aspects of the VMSR program, including FDA’s approach to determining the eligibility of product codes for the program and the conditions for submitting medical device reports for device malfunctions in summary format under the program,” the document says.

The guidance contains an Introduction, Background, Principles of Voluntary Malfunction Summary Reporting, Voluntary Malfunction Summary Reporting Program Eligibility and Scope, VMSR Program Conditions, and an Appendix.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome