FDA Proposed Rule October 17, 2016
The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic submission of the device label and package insert of certain home-use devices when these devices are listed with FDA. The electronic submission requirements of the proposed rule would be limited to only devices labeled for home use that are regulated by the Center for Devices and Radiological Health (CDRH) as class II and class III devices. For purposes of the proposed rule, a “home-use device” is any medical device that is labeled for use outside a professional health care facility. Class I devices and devices regulated by CBER are not within the scope of the proposed rule, except for the authorized voluntary submission of a device’s label and package insert for these home-use devices.
The proposed rule would help to address the concerns by making it possible for FDA to establish an electronic database, published online and accessible to the public through the Internet, of labels and package inserts for listed home-use devices that would be submitted. The FDA-managed or partner Internet Web site would provide a consolidated and easily accessible source of FDA database information concerning class II and class III home-use devices, including their approval or clearance status, intended uses, limitations, setup, and operation.
Unless a request for waiver is granted, all of the information submitted to FDA under the proposed rule would have to be submitted by electronic means, as required by section 510(p) of the FD&C Act, in a format to be specified by FDA that we can process, review, and archive.
Submit either electronic or written comments on the proposed rule by January 17, 2017.
- Submit electronic comments in the following way:
Federal eRulemaking Portal
Follow the instructions for submitting comments. Comments submitted electronically, including attachments, will be posted to the docket unchanged.
- Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper submissions)
Division of Dockets Management (HFA-305),
Food and Drug Administration,
5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
All submissions received must include the Docket No. FDA-2016-N-2491 for “Electronic Submission of Labeling for Certain Home-Use Medical Devices” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
For More Information please visit the Federal Register link.
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