FDA Update

Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers – Guidance for Industry

The U.S. Food and Drug Administration (FDA) has recently released a guidance document that directly affects our industry: Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers – Guidance for Industry.

The guidance hopes to provide clarity on the VMSR program. The FDA’s aim is to convey several aspects of the program to help determine the eligible product codes for the program and the conditions for submitting medical device reports (MDRs).

Key Points (Expanded):

• Purpose: The VMSR Program is designed to streamline the reporting of device malfunctions for manufacturers, reducing the administrative burden associated with individual reports while still providing valuable safety data to the FDA.
• Eligibility: The program is open to manufacturers of eligible product codes, which are typically those with a history of frequent or minor malfunctions.
• Report Types: While the VMSR Program does not cover reports of serious adverse events, recalls, or field corrections, it can be used to report less severe malfunctions that do not pose immediate risks to patient safety.
• Participation: Manufacturers can elect to participate in the program by submitting summary malfunction reports for their eligible product codes. These reports should provide a concise overview of the malfunction, including the number of affected devices, the nature of the problem, and any corrective actions taken.

Benefits:

• Reduced Reporting Burden: By submitting summary reports, manufacturers can significantly reduce the number of individual reports they need to file with the FDA, saving time and resources.
• Improved Efficiency: The VMSR Program can streamline the reporting process, allowing manufacturers to focus on other important tasks.
• Data Analysis: The FDA can use the data collected through the VMSR Program to identify trends, potential safety issues, and areas for improvement in device design and manufacturing.

Additional Considerations:

• Compliance: Manufacturers participating in the VMSR Program must still comply with all other reporting requirements, such as reporting serious adverse events and recalls.
• Data Confidentiality: The FDA maintains the confidentiality of the data submitted through the VMSR Program, protecting manufacturers’ proprietary information.
• Program Evaluation: The FDA periodically evaluates the effectiveness of the VMSR Program to ensure that it continues to meet its objectives and provide valuable safety data.

Overall, the VMSR Program offers a valuable tool for manufacturers to meet their reporting obligations while reducing administrative burdens. By participating in the program, manufacturers can contribute to the overall safety and effectiveness of medical devices.

Should you have any questions or require further information, please do not hesitate to reach out to us. Your success and satisfaction remain at the forefront of our endeavors.

For the original update, please visit the FDA’s website.

We are dedicated to navigating this process diligently, underscoring our unwavering commitment to you, our valued clients. As always, your trust in mdi Consultants drives us to continually improve and deliver excellence in every aspect of our operations.

Questions

For any further questions regarding the remanufacturing of medical devices, as well as assistance in this process, please email mdi Consultants at [email protected] RE: Malfunction Reporting.