The U.S. Food and Drug Administration (FDA) recently updated the Voluntary Malfunction Summary Reporting (VMSR) program eligibility status of several medical device product codes. Some previously eligible devices are now ineligible for VMSR, meaning manufacturers must now submit standard individual Medical Device Reports (MDRs) for the newly ineligible products. FDA notified companies with affected products of the change via email.
MDR and VMSR
FDA requires manufacturers of medical devices to submit an MDR when they learn their device has contributed to a death or serious injury, or when they become aware that a device has malfunctioned and could contribute to death or serious injury were it to reoccur. These reports must be submitted to FDA electronically within 30 calendar days of the responsible party becoming aware of the malfunction.
In 2018, FDA introduced the VMSR to lower the number of reports required for low-risk device manufacturers. Under the program, manufacturers of eligible devices may send a summary report of all adverse events on a quarterly basis instead of individual reports for every event. The program only applies to events that did not contribute to a death or serious injury and only to manufacturers (not importers or user facilities). FDA only considers VMSR eligibility for product codes that have existed for two or more years. Companies can determine if their device is eligible for the VMSR program by checking the product code in FDA’s Product Code Classification Database.
My Product was Affected. What Do I Do Now?
If an adverse event occurred with your newly ineligible device recently and you did not yet report it in a quarterly summary, you have 30 calendar days from receipt of FDA’s status change email to submit a standard MDR to FDA. If you reported the event in your most recent summary report, then no immediate action is required. Any future adverse events must be submitted to FDA as individual MDRs.
MDR submissions must follow FDA’s strict formatting rules. These reports must be submitted to FDA electronically through the agency’s Electronic Submissions Gateway (ESG) using a Web Trader Account. Obtaining an account can be a lengthy and involved process. Users must submit a letter of non-repudiation and obtain a third party digital certificate, among other requirements. An MDR must be submitted to FDA within 30 calendar days of becoming aware of a reportable event, making it urgent to set up your account as soon as possible so your company is ready to submit a report should an adverse event occur.
As a benefit of Registrar Corp’s Official Correspondent and U.S. Agent services for medical device companies, our Regulatory Specialists will assist your company in submitting all of your reports in eMDR format at no additional cost. Designate Registrar Corp now so we can prepare your account and have it ready when the time is necessary. Other benefits of our Official Correspondent and U.S. Agent services include detention assistance, guidance on Unique Device Identifier requirements, and FDA compliance monitoring. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.