Devices

Industry VMSR Improvement Suggestions

AdvaMed and the Medical Device Manufacturers Association (MDMA) say there are ways FDA can improve the draft guidance on its Voluntary Malfunction Summary Reporting (VMSR) program for manufacturers. In its comment letter, AdvaMed says it appreciates the agency’s effort to establish a summary reporting program for medical device malfunctions as called for in the commitment letter that was the basis for reauthorizing MDUFA 4. “We believe a useful and reasonable step would be to publish a clear list of inclusion/exclusion criteria based on all relevant code types to add clarity in eligibility considerations,” the association writes. “While eligible procedures can be found in the Product Classification Database, it would also be helpful in furtherance of FDA efforts to help manufacturers better understand and use the program to provide a list of codes eligible for VMSR reporting directly on the FDA Web site,” AdvaMed said. “This eligible code list could be updated as needed and serve as a ready complement to the guidance.”

AdvaMed included specific line-by-line comments.

MDMA said it supports the goal of the VMSR program and believes the draft guidance is suitable in principle, but that FDA should further streamline the process to enhance program participation. Its recommendations were that FDA:

publish additional guidance outlining the essential requirements for submitting reports on form FDA 3500A to provide notice to stakeholders on how to participate in the VSMR program and to facilitate consistent application of the essential requirements of the summary reports from reporters to FDA;
allow reports to be sent for each unique device brand name or model only and not require separate submissions for each unique combination of brand name, model, and product problem experienced; and
allow manufacturers to supplement a malfunction summary report consistent with the existing Summary Malfunction Reporting Schedule under the Medical Device Reporting regulation.

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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