Open for industry feedback

Proposed rules, draft specs, ballots and RFIs with an open comment window. Tracked proceedings keep their full history — from proposal to final decision — so you can follow where a requirement is heading.

Tracked — open for comment

Closing soon Health and Human Services Department, Food and Drug Administration

FDA Proposes Reclassifying Digital Breast Tomosynthesis Systems from Class III to Class II

💬 Comments close in 2 days (Oct 9)

2 updates · 1 brief · view timeline →

Closing soon Health and Human Services Department, Centers for Medicare & Medicaid Services

CMS proposes RAPID coverage pathway for accelerated Medicare device coverage

💬 Comments close in 6 days (Oct 13)

2 updates · 1 brief · view timeline →

Closing soon Health and Human Services Department, Food and Drug Administration

FDA proposes Class I classification for specific medical device accessories under FDARA

💬 Comments close in 9 days (Oct 16)

2 updates · 1 brief · view timeline →

Closing soon Health and Human Services Department, Food and Drug Administration

FDA Proposes Downgrading Bladder Cancer Detection Endoscopes from Class III to Class II

💬 Comments close in 9 days (Oct 16)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA seeks public comment on proposed information collection for allegations of regulatory misconduct submitted to CDRH

💬 Comments close in 19 days (Oct 26)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Disease Control and Prevention

CDC Seeks Public Comment on National Death Index Data Collection Renewal

💬 Comments close in 20 days (Oct 27)

4 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Seeks Comment on Proposed Information Collection for Medical Device Removals and Corrections Reporting

💬 Comments close in 23 days (Oct 30)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Seeks Public Comment on Proposed Information Collection for Medical Device Voluntary Improvement Program

💬 Comments close in 26 days (Nov 2)

3 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Children and Families Administration

HHS Proposes Updated Mental Health and Health Intervention Forms for Refugee Children with DHS Data Sharing

💬 Comments close in 28 days (Nov 4)

4 updates · 2 briefs · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Seeks Public Comment on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulation

💬 Comments close in 33 days (Nov 9)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Seeks Public Comment on Pregnancy Exposure Registry Survey of Healthcare Providers

💬 Comments close in 33 days (Nov 9)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration, Health Resources and Services Administration

HHS Seeks Input on Regulating Deceased Donor Islet Cells for Type 1 Diabetes Treatment

💬 Comments close in 33 days (Nov 9)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Seeks Comment on Proposed Medical Device Tracking Information Collection

💬 Comments close in 34 days (Nov 10)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Disease Control and Prevention

CDC seeks public comment on using data intermediaries for public health data exchange

💬 Comments close in 44 days (Nov 20)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Issues Draft Guidance on Premarket Submissions for Robotically-Assisted Surgical Devices

💬 Comments close in 48 days (Nov 24)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Proposes Information Collection for Tracking Medical Devices

💬 Comments close in 54 days (Nov 30)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration RIN 0910-AJ02

FDA Proposes Mandatory GRAS Notice Submission for Food Substances

💬 Comments close in 63 days (Dec 9)

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Announces Medical Device User Fee Rates for FY 2027 Effective October 2026

💬 Open for industry feedback

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services

CMS renews NCQA's deeming authority for MA HMOs and PPOs for 6 years

💬 Open for industry feedback

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services

CMS renews DNV Healthcare USA Inc.'s hospital accreditation approval

💬 Open for industry feedback

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Centers for Medicare & Medicaid Services

HHS Publishes Secretarial Comments on Battelle/CBE 2025 Annual Quality Measures Report to Congress

💬 Open for industry feedback

2 updates · 1 brief · view timeline →

Open for comment Health and Human Services Department, Food and Drug Administration

FDA Announces Microbiology Devices Panel Meeting on Pathogen-Agnostic Sequencing for Emergency Preparedness

💬 Open for industry feedback

2 updates · 1 brief · view timeline →

Closed — awaiting final decision

Closed — awaiting decision Health and Human Services Department, Children and Families Administration RIN 0970-AD30

HHS Proposes Revised Head Start Standards to Reduce Federal Burden

💬 Comment window closed

3 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Children and Families Administration

HHS Proposes Consolidation and Revision of ORR Unaccompanied Alien Child Health Forms with DHS Data Sharing Updates

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV93

CMS Proposes Revised Medicaid Hold Harmless Threshold for Health Care-Related Taxes

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department,

HHS Requests Input on Vaccine Recommendation Categories and Shared Decision-Making Framework

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration

FDA Proposes New Information Collection for Investigational New Drug Application Requirements

💬 Comment window closed

3 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration

FDA Proposes Information Collection for ASCA Accreditation Program

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration

FDA Seeks Comment on Infant Formula Information Collection Requirements

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV82

CMS Proposes CY 2027 Physician Fee Schedule: Interoperability, Quality, and Payment Updates Open for Comment

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration RIN 0910-AH59

FDA Proposes Extending Tobacco Establishment Registration and Product Listing to Foreign Facilities

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AW01

CMS Issues RFI to Update CLIA Regulations for 1988 Clinical Laboratory Standards

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Food and Drug Administration RIN 0910-AI94

FDA Proposes Streamlined Registration for Distributed Manufacturing Establishments

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV80

CMS Proposes CY 2027 Home Health Payment Rates, Case-Mix Recalibration, and QRP/HHVBP Alignment Changes

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV83

CMS Proposes 2027 OPPS/ASC Payment Updates, Expands Prior Auth, and Issues HPT Standardization RFI

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, Centers for Medicare & Medicaid Services RIN 0938-AV81

CMS proposes CY 2027 updates to ESRD PPS, AKI dialysis payment, and Quality Incentive Program

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department, RIN 0936-AA16

HHS Seeks Input on Anti-Kickback Safe Harbors and Beneficiary Inducements Exceptions for Clinical Trial Remuneration

💬 Comment window closed

2 updates · 1 brief · view timeline →

Closed — awaiting decision Health and Human Services Department

ONC Opens 60-Day Comment Window on Proposed Information Collection Under Paperwork Reduction Act

💬 Comment window closed

5 updates · 1 brief · view timeline →

Other open comment items

Comment opportunities from non–Federal Register sources — no lifecycle tracking.

Notable HHS 💬 Comments close in 6 days (Oct 13)

SAMHSA Proposes New Data Security Requirements for Accessing Confidential Behavioral Health Data

SAMHSA seeks OMB clearance for updated information collection defining security standards that entities must meet to access confidential substance abuse and mental health data under federal confidentiality protections. The Substance Abuse and Mental Health Services Administration (SAMHSA) has...

Sources

Health and Human Services Department, Substance Abuse and Mental Health Services Administration · Agency Information Collection Activities: Proposed Collection; Public Comment Request: Information Collection Request Title: SAMHSA Data Security Requirements for Accessing Confidential Data (OMB No. 0930-0396) · Aug 13
FYI HHS 💬 Comments close in 12 days (Oct 19)

HRSA Proposes Revised Data Collection for Rural Maternity and Obstetrics Management Strategies Program

HRSA seeks public comment on a revised information collection request to evaluate the Rural Maternity and Obstetrics Management Strategies Program, with implications for health IT data reporting in rural maternal health initiatives. The Health Resources and Services Administration (HRSA)...

Sources

Health and Human Services Department, Health Resources and Services Administration · Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Maternity and Obstetrics Management Strategies Program Data Collection, OMB No. 0915-0394-Revision · Aug 19
Notable HHS 💬 Comments close in 19 days (Oct 26)

NIH Issues Draft Policy on Sharing Study Results with Clinical Research Participants

The draft NIH policy aims to facilitate sharing summary-level study results with clinical research participants, with public comment open until October 26, 2026. The National Institutes of Health (NIH) has released a draft policy on sharing summary-level study results with clinical research...

Sources

Health and Human Services Department, National Institutes of Health · Draft NIH Policy on Sharing Summary Level Study Results With Clinical Research Participants · Sep 25
High CMS 💬 Open for industry feedback

Hospital groups warn CMS 340B drug payment cuts may be 'unlawful' and harm safety-net providers

Major provider associations say CMS’ proposed OPPS rule would cut 340B reimbursement by roughly 40%, threatening hospital finances and potentially triggering litigation over statutory authority. The proposed 2027 Hospital Outpatient Prospective Payment System (OPPS) rule from CMS includes a...

Sources

FierceHealthcare · Hospital groups rail against CMS' proposed 340B changes, site-neutral payments · Sep 1

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