FDA Proposes Labeling Submission Rules for Some Home-Use Medical Devices

In an effort to make information on the use of certain higher-risk home-use medical devices more widely available, the U.S. Food and Drug Administration (FDA) has proposed regulations that would require manufacturers of certain devices to electronically submit labeling and packaging information to the agency.

So-called home-use medical devices are generally defined as any medical device that is intended for use outside of a professional healthcare facility. The proposed labeling regulations were published in the Federal Register in mid-October 2016, and would be applicable to Class II and Class III home-use devices.

Reportedly, the FDA will initially accept labeling and packaging information in PDF format for required electronic submissions. However, manufacturers will be expected to eventually adopt the agency’s structured product labeling (SPL) document standard for submissions to aid in storage and retrieval of labeling information and to facilitate database search efforts.

The FDA is accepting comments on its proposed regulations until mid-January 2017. Read the complete text of the proposed regulations as published in the Federal Register.

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