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FDA Proposes to Require Label Submissions for Class II and Class III Home-Use Devices

On October 14, 2016, the U.S. Food and Drug Administration (FDA) announced a proposed rule that would require device manufacturers to submit labels and package inserts to FDA electronically when listing Class II and Class III home-use devices. The rule would allow manufacturers to submit labels and package inserts for Class I or other excluded home-use devices voluntarily.

FDA defines a home-use device as “a medical device intended for users in any environment outside of a professional healthcare facility.” These devices are intended for use in homes and healthcare facilities where:

  • A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
  • A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.

Some examples of class II home-use devices include powered wheelchairs as well as certain pregnancy test kits. Examples of class III home-use devices include implantable pacemakers and replaceable heart valves.

According to FDA, the proposed rule would “better allow manufacturers to provide such facilities with information that is more robust, up-to-date, and user-friendly.” Once finalized, FDA has plans to make the device labeling information public through an FDA-managed or partner website.  If finalized, manufacturers of class II and class III home-use devices would have to begin submitting labeling information 90 days after the publication of the final rule.

FDA opened this proposed rule for comments on October 17, 2016 for a 90-day period.  Interested parties may submit electronic comments at www.regulations.gov. Enter docket number FDA-2016-N-2491 in the search box.  FDA will review all comments before the release of the final rule, expected January 17, 2017.

Registrar Corp is a U.S. FDA consulting firm that helps businesses comply with FDA regulations for medical devices, including labeling requirements. You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.