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FDA comment periods: Medical devices

7 open comment periods and 0 upcoming effective dates tagged Medical devices. Subscribe (iCal).

Open for comment

Closes	Document
closes in 9 days Oct 26, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health Notice · published Aug 26, 2026 · FDA-2026-N-8482 Medical devices
closes in 13 days Oct 30, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections Notice · published Aug 31, 2026 · FDA-2026-N-9349 Medical devices
closes in 23 days Nov 9, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun)) Notice · published Oct 8, 2026 · FDA-2026-N-7129 Medical devices
closes in 24 days Nov 10, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking Notice · published Sep 11, 2026 · FDA-2026-N-9350 Medical devices
closes in 31 days Nov 17, 2026	Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice · published Sep 18, 2026 · FDA-2026-D-9429 Vaccines / biologics Medical devices
closes in 38 days Nov 24, 2026	Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice · published Sep 25, 2026 · FDA-2026-N-9505 Medical devices
closes in 44 days Nov 30, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects and Institutional Review Boards Notice · published Sep 29, 2026 · FDA-2026-N-10132 Clinical Medical devices

Upcoming effective dates

None upcoming.

Recently closed

Closes	Document
closed 1 day ago Oct 16, 2026	Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments Proposed Rule · published Aug 17, 2026 · FDA-2025-N-6224 Medical devices
closed 1 day ago Oct 16, 2026	Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer Proposed Rule · published Aug 17, 2026 · FDA-2026-N-8249 Medical devices
closed 4 days ago Oct 13, 2026	Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability Notice · published Aug 14, 2026 · FDA-2026-D-7957 CMC (chemistry, manufacturing & controls) Medical devices
closed 8 days ago Oct 9, 2026	Radiology Devices; Reclassification of Digital Breast Tomosynthesis System Proposed Rule · published Aug 10, 2026 · FDA-2026-N-7630 Medical devices
closed 15 days ago Oct 2, 2026	Modification of Certain Terminology in Title 21; Reopening of the Comment Period Proposed Rule · published Aug 3, 2026 · FDA-2026-N-2886 Clinical Vaccines / biologics Medical devices Food & dietary supplements Tobacco
closed 15 days ago Oct 2, 2026	Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability Notice · published Aug 3, 2026 · FDA-2026-D-4272 CMC (chemistry, manufacturing & controls) Vaccines / biologics Medical devices
closed 32 days ago Sep 15, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Program Notice · published Jul 17, 2026 · FDA-2026-N-6876 Medical devices
closed 32 days ago Sep 15, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun)) Notice · published Jul 17, 2026 · FDA-2026-N-7129 Medical devices
closed 54 days ago Aug 24, 2026	Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066 Notice · published Aug 24, 2026 · FDA-2004-N-0451 Medical devices
closed 57 days ago Aug 21, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notifications Submission Notice · published Jul 22, 2026 · FDA-2026-N-1849 Medical devices
closed 73 days ago Aug 5, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices Notice · published Jul 6, 2026 · FDA-2026-N-2915 Medical devices
closed 75 days ago Aug 3, 2026	Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability Notice · published Jun 3, 2026 · FDA-2016-D-1307 Medical devices
closed 103 days ago Jul 6, 2026	Modification of Certain Terminology in Title 21 Proposed Rule · published May 6, 2026 · FDA-2026-N-2886 Clinical Vaccines / biologics Medical devices Food & dietary supplements Tobacco
closed 109 days ago Jun 30, 2026	Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments Notice · published May 1, 2026 · FDA-2026-N-4268 Medical devices
closed 117 days ago Jun 22, 2026	Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice · published Apr 20, 2026 · FDA-2025-D-7121 Medical devices
closed 129 days ago Jun 10, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications On Medical Devices and Radiation-Emitting Products Notice · published May 11, 2026 · FDA-2025-N-2220 Medical devices
closed 130 days ago Jun 9, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices Notice · published Apr 10, 2026 · FDA-2026-N-2915 Medical devices
closed 141 days ago May 29, 2026	Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests Proposed Rule · published Mar 30, 2026 · FDA-2026-N-2590 Medical devices
closed 152 days ago May 18, 2026	Medical Devices; Radiology Devices; Classification of Blood Irradiators Proposed Rule · published Mar 18, 2026 · FDA-2025-N-5996 Vaccines / biologics Medical devices
closed 152 days ago May 18, 2026	Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis Proposed Rule · published Mar 18, 2026 · FDA-2025-N-5995 Vaccines / biologics Medical devices
closed 152 days ago May 18, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notifications Submission Notice · published Mar 19, 2026 · FDA-2026-N-1849 Medical devices
closed 173 days ago Apr 27, 2026	Determination of Regulatory Review Period for Purposes of Patent Extension; MERIT MEDICAL WRAPSODY Notice · published Feb 26, 2026 · FDA-2025-E-1228, FDA-2025-E-1229 Medical devices
closed 173 days ago Apr 27, 2026	Determination of Regulatory Review Period for Purposes of Patent Extension; LIMFLOW SYSTEM Notice · published Feb 26, 2026 · FDA-2024-E-3555, FDA-2024-E-3564, FDA-2024-E-3565 Medical devices
closed 173 days ago Apr 27, 2026	Determination of Regulatory Review Period for Purposes of Patent Extension; AEROPACE Notice · published Feb 26, 2026 · FDA-2025-E-1226 Medical devices

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