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Compliance In Focus
Posted by John Lehmann on Fri, Apr 4, 2014

What Makes a Device Class III?

According to an article in “The Gray Sheet” the FDA is proposing new regulatory language to What Makes a Device Class IIIdetermine what devices designated Class III devices and not suitable for down-classification.

The article states there has been much confusion about whether the designation of “high risk” means a device should be class III and require a PMA, or whether an understanding of risk and how they might be controlled could allow device could be downclassified to class II or I.

A proposed rule attempts to clear up the confusion by introducing five new defined categories that describe when a class III designation will be necessary.  They are:

  • Devices that present known risks that cannot be controlled
  • Devices for which the risk-benefit profile  is unknown or unfavorable
  • Devices for which a full review of manufacturing information is necessary
  • Devices for which pre-market review of any change affecting safety or effectiveness is necessary
  • Combination products which have a device primary model of action, but which require a finding that a drug constituent is safe and effective (or that a biologic is safe, pure and potent)

A “high-risk” device is intended for use in supporting or sustaining human life, or it holds substantial importance in preventing impairment of health, or it presents a “potential unreasonable risk of illness or injury.”

There is confusion around current regulations that say to be considered a class III, a product must be high risk and there must be “insufficient  information…to determine that general controls and/or special controls are sufficient to provide reasonable assurance of safety and effectiveness {for the device}.”

The FDA feels the five categories should lessen the confusion and describe the type of controls that should be reserved for class III oversight.

The proposed rule was issued primarily to implement revisions to the device reclassification law enacted by the FDA Safety an Innovations Act of 2012.  The proposal aims to generally clarify FDA’s device classification regulations, and to implement FDA Safety and Innovation Act provisions that require administrative orders rather than rules for reclassifications.   All public comments on the proposal are due by June 23rd.

Let us know your thoughts on the new proposal.

Photo Credit: Leo Reynolds

Drugs & Devices Trial Guideline


Topics: Medical Devices, Class III, FDA Safety and Innovations Act


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