Voluntary Malfunction Summary Reporting Program for Medical Devices
This guidance explains the Voluntary Malfunction Summary Reporting (VMSR) Program which allows manufacturers to report certain device malfunctions in summary form quarterly instead of individual 30-day reports. It applies to manufacturers of devices within eligible product codes and aims to streamline malfunction reporting while maintaining FDA's ability to monitor device safety.
What You Need to Know? 👇
What is the FDA’s Voluntary Malfunction Summary Reporting (VMSR) Program?
The VMSR Program allows manufacturers of eligible medical devices to report certain malfunctions in quarterly summary format instead of individual 30-day reports, streamlining the reporting process while maintaining FDA oversight.
Which medical devices are eligible for VMSR Program participation?
Devices must be in eligible product codes determined by FDA, typically existing for at least two years. FDA evaluates eligibility based on benefit-risk profiles, postmarket safety data, and whether quarterly reporting provides sufficient information for safety monitoring.
When must manufacturers submit individual reports instead of summary reports under VMSR?
Individual reports are required for: 5-day reportable events, malfunctions subject to Class I/II recalls, new types of malfunctions, when FDA determines individual reporting is necessary for public health issues, or manufacturer-specific compliance issues.
How often must VMSR summary reports be submitted to FDA?
Summary reports must be submitted quarterly by specific deadlines: April 30 (Q1 events), July 31 (Q2 events), October 31 (Q3 events), and January 31 (Q4 events), using electronic Form FDA 3500A.
Can manufacturers voluntarily exit the VMSR Program?
Yes, participation is voluntary and manufacturers can leave anytime. Upon exit, they must resume individual 30-day malfunction reporting under 21 CFR 803.50 and update their MDR procedures accordingly.
What information must be included in VMSR summary reports?
Reports must include device identification, brand name, product code, manufacturer details, event descriptions, adverse event codes, investigation findings, and the number of events summarized, using separate reports for each unique device/problem combination.
What You Need to Do 👇
Recommended Actions
- Verify product code eligibility for VMSR Program participation
- Update MDR procedures to include:
- Process for identifying when individual vs summary reporting is required
- Quarterly reporting schedule and format requirements
- Supplemental reporting procedures
- Implement system to track and categorize malfunction events by:
- Brand name
- Device model
- Problem codes
- New vs previously reported malfunction types
- Train relevant personnel on:
- VMSR Program requirements and conditions
- Form FDA 3500A completion for summary reports
- Individual reporting triggers
- Supplemental reporting requirements
- Establish process to monitor FDA communications regarding:
- Product code eligibility changes
- Requests for individual reporting
- Program updates
- Maintain documentation of:
- Decision to participate in VMSR Program
- All summary and individual reports submitted
- Compliance with program conditions
Key Considerations
Safety
- Individual reporting is required for:
- Reportable deaths and serious injuries
- Events associated with 5-day reports
- Events subject to certain device recalls
- When FDA determines individual reporting is needed for public health issues
- New types of malfunctions not previously reported
- Summary reports must be submitted quarterly according to defined schedule
- Each summary report must include specific information like device identifier, brand name, model number, description of events, etc.
Other considerations
- Participation is voluntary and manufacturers can opt out at any time
- Separate summary reports required for each unique combination of brand name, device model and adverse event codes
- Product codes must be eligible for VMSR Program participation
- Supplemental reports must be submitted when new information becomes available
- Reports must be submitted electronically using Form FDA 3500A
Relevant Guidances 🔗
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- Quality System Information Requirements for Premarket Submissions
Related references and norms 📂
- ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes