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US Regulators Propose Labeling Submission Rules for Higher-Risk Home Use Medical Devices


  • The US FDA has proposed requiring electronic submission of labeling data for Class II and III home-use devices.
  • Submitted data would be made publically available to reduce risk of misuse of these products.
  • Class I home-use device manufacturers would submit labeling data on a voluntary basis under the rule.

US e-labeling submission rule for home-use medical devicesMedical device regulators at the US Food and Drug Administration have proposed requirements for manufacturers of higher-risk home-use devices to electronically submit their labeling information to the agency.

The rule targets Class II and III devices labeled for home use, and would also make labeling data for these products publically available given what the agency calls their “significant public health importance to patients, caregivers, and health care professionals.” In addition, manufacturers of Class I home-use devices will have the option of voluntarily submitting labeling information according to the rule.

The FDA will accept comments on the proposed rule until mid-January 2017.

US regulators will initially accept labeling and package insert submissions in PDF format. Eventually, however, the FDA plans to utilize its Structured Product Labeling (SPL) document standard for these submissions in order to allow easier storage, retrieval and searching of labeling data of home-use devices. Under the rule, the agency would use its FURLS database to store submitted information.

What is a “home-use device?”

The FDA broadly defines home-use devices as any medical device that is labeled for use outside a professional health care facility. The labeling submission rule is intended to help mitigate the risk of misuse of these devices stemming from users losing labeling and operating instructions.


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