FDA update – March 9, 2011

Federal Register: Medical Device Reporting; Malfunction Reporting Frequency

The Food and Drug Administration (FDA) is clarifying that device manufacturers and importers of all devices, including class I and those class II devices that are not permanently implantable, life supporting, or life sustaining, must continue to submit malfunction reports in full compliance with FDA's Medical Device Reporting regulation

The malfunction reporting requirements for class III devices and those class II devices that are permanently implantable, life supporting, or life sustaining were not altered by FDAAA. Under the amended section 519(a), device manufacturers and importers are to continue to submit malfunction reports in accordance with part 803 for all class III devices and for those class II devices that are permanently implantable, life supporting, or life sustaining, unless the Secretary of Health and Human Services (the Secretary) (and, by delegation, FDA) grants an exemption.

However, FDAAA changed malfunction reporting requirements for class I devices and those class II devices that are not permanently implantable, life supporting, or life sustaining.

  •  Under section 519(a) of the FD&C Act, as amended by FDAAA, the Secretary (and, by delegation, FDA) is required to publish a notice in the Federal Register or send a letter to the person who is the manufacturer or importer of a class I device or a class II device that is not permanently implantable, life supporting, or life sustaining, if FDA finds that such a device should be subject to part 803 in order to protect the public health.
  •  If such class I or class II devices are not the subject of an FDA notice or letter, the malfunction reports for these devices are to be submitted in accordance with the criteria established by the Secretary (and, by delegation, FDA), which criteria shall require the reports to be in summary form and made on a quarterly basis.
  •  FDA intends to provide notice in the Federal Register that lists the types of devices that should be subject to part 803 in order to protect the public health, as required by section 519(a)(1)(B)(i)(III) of the FD&C Act).
  •  In addition, FDA intends to, by rulemaking, establish malfunction reporting criteria for devices subject to section 519(a)(1)(B)(ii) of the FD&C Act. 

If there are any questions on these new FDA Rule please contact us via email at info@mdiconsultants.com and Ref: Reporting Frequency.