The new article addresses the aspects related to the principles to be followed with respect to voluntary reporting, and also describes the approach the authority applies when determining the eligibility criteria to be considered.

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to the Voluntary Malfunction Summary Reporting (VMSR) Program for medical device manufacturers. The document provides an overview of the applicable regulatory framework, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing regulatory requirements and has been agreed with the authority in advance. Once finalized, the document will represent the authority’s current position on the matter, so the recommendations provided therein could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations. As of December 2022, the document is published for comment purposes only. The authority encourages all the parties involved in operations with medical devices to provide their feedback and suggestions with respect to the matter, so it can be taken into consideration by the FDA when creating a final version of the guidance. 

The scope of the guidance covers, inter alia, the principles to be followed by medical device manufacturers in order to ensure compliance with the applicable regulatory requirements. 

 

VMSR: Key Principles 

First of all, the document provides a list of the principles to be followed with respect to voluntary incident reporting. These principles include, inter alia, the following ones:

  1. The collection of information in summary format should allow FDA to collect sufficient detail to understand reportable malfunction events.
  2. To increase efficiency, summary malfunction reporting should occur in a common format for the electronic reporting system used.
  3. Information about reportable malfunctions should be transparent to FDA and to the public, regardless of whether the information is reported as an individual MDR or a summary report. In this respect, the authority additionally emphasizes that the information subject to protection under the respective requirements a summary malfunction report contains should not be disclosed and made publicly available, so it should be removed before the report will be released.
  4. Manufacturers should communicate information regarding an imminent hazard at the earliest time possible. 
  5. Summary reporting is meant to streamline the process of reporting malfunctions. At the same time, the authority explicitly states that other regulatory requirements related to medical device reporting (MDR) remain intact.
  6. Summary reporting information should not be duplicative of information received through other MDR reporting processes.

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