Intent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2014-D-0967] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.” This guidance describes FDA's intent to exempt certain unclassified medical devices from premarket notification requirements. At this time, and based on the information currently available to the Agency, FDA believes the devices identified in this guidance meet the standards for exemption from premarket notification. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices. DATES: The announcement of the guidance is published in the Federal Register on June 5, 2026. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential informatio…