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Public Policy Tipoffs Involving New Hampshire Newsletter for 2026-11-02 ( 18 items )  
AdvaMed Urges FDA to Apply Risk-Based Criteria to Class I Accessory Classifications Instead of Excluding Device-Specific Accessories (10)
WASHINGTON, Nov. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. October 16, 2026 Food and Drug Administration Center for Devices and Radiological Health 10903 New Hampshire Avenue Silver Spring, MD 20993 Re: Docket No. FDA-2025-N-6224 -- Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments Dear Sir/Madam, The Advanced Medical Technology more ST

American Hospital Association Urges FDA to Refine Risk-Based Oversight for Generative AI Medical Devices (10)
WASHINGTON, Nov. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. October 19, 2026 Michelle Tarver Director Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993 RE: FDA-2026-N-7874 Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback Dear Director Tarver, On behalf of our nearly 5,000 membe more ST

American Medical Association Urges FDA to Keep Rigorous Evidence Standards for Generative AI Medical Devices (10)
WASHINGTON, Nov. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. October 16, 2026 Rick Abramson, MD Director Digital Health Center of Excellence Center for Devices and Radiological Health U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Re: Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback Dear Director Abramson: On more ST

American Society for Gastrointestinal Endoscopy Urges FDA to Use Risk-Based Total Product Lifecycle Oversight for Generative AI Medical Devices (10)
WASHINGTON, Nov. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. October 19, 2026 Kyle Diamantas, J.D. Acting Commissioner of Food and Drugs U.S. Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993 Re: Docket FDA-2026-N-7874 - Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback Dear Acting Commissioner Diamantas: The American Society for G more ST

ATA Action Urges FDA Risk Based Oversight and Clear Accountability for Generative AI Medical Devices (10)
WASHINGTON, Nov. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. October 19, 2026 Michelle Tarver, M.D., Ph.D. Director, Center for Devices and Radiological Health U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 RE: ATA Action Comments in Response to Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback (Docket No. FDA-2026-N-7874) Dea more ST

Clean Water Act Permitting - Overview & Policy Issues Topic of CRS Report (Part 1 of 3) (10)
WASHINGTON, Nov. 1 (TNSLrpt) -- The Congressional Research Service issued the following report (No. R49486) on Oct. 14, 2026, entitled "Clean Water Act Permitting: Overview and Policy Issues" by environmental policy specialist Laura Gatz. Here are excerpts: * * * SUMMARY The Federal Water Pollution Control Act, commonly referred to as the Clean Water Act (CWA), is the principal federal law in the United States governing water pollution. To help achieve its goals, the statute prohibits the discharge of pollutants from any point source (e.g., more PR

Clean Water Act Permitting - Overview & Policy Issues Topic of CRS Report (Part 3 of 3) (10)
WASHINGTON, Nov. 1 (TNSLrpt) -- The Congressional Research Service issued the following report (No. R49486) on Oct. 14, 2026, entitled "Clean Water Act Permitting - Overview and Policy Issues:" (Continued from Part 2 of 3) * * * Congressional Interest - Hearings and Legislation in the 119th Congress Many Members have shown interest in policy issues pertaining to CWA permitting-especially permitting reform-in recent Congresses. Congress has held hearings that have included discussion of CWA permitting, and some Members have introduced legisl more PR

Consumer Technology Association Urges FDA to Build a Practical Postmarket Monitoring Framework for Generative AI Medical Devices (10)
WASHINGTON, Nov. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. October 19, 2026 Kyle A. Diamantas, Acting Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Docket Number: FDA-2026-N-7874 Dear Acting Commissioner Diamantas: The Consumer Technology Association (CTA) appreciates the opportunity to comment on the Considerations for the Regulation of Generative AI-Enabled Medical Devices more ST

Directed Energy Weapons Agency Police Report Alleges Ongoing Attacks Against Kimberly Colombo in Massachusetts (10)
WASHINGTON, Nov. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. Direct Energy Weapons Agency, Inc. www.dewagency.org 1 of 8 About us This report has been prepared by DEW Police (Directed Energy Weapons Police) a division of Direct Energy Weapons Agency, Inc. (dewagency.org) is a 501(c)(3) not for profit organization that specializes in Directed Energy Cases. We ARE NOT your local police. If you are in danger or have an emergency and i more ST

Federal Register: FDA Finalizes Guidance on Mandatory Recall Authority for Cosmetic Products (10)
WASHINGTON, Oct. 31 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register. * * * Questions and Answers Regarding Mandatory Cosmetics Recalls; Guidance for Industry; Availability The Food and Drug Administration (FDA) is announcing the availability of a final guidance entitled "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry." The guidance document provides answers to common questions that might arise about FDA's mandatory more PR

Federal Register: FDA Reclassifies DermaSensor Inc. AI-Powered Skin Cancer Diagnostic Device to Expand Clinical Access (10)
WASHINGTON, Oct. 31 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register. * * * Medical Devices; General and Plastic Surgery Devices; Classification of the Software-Aided Adjunctive Diagnostic Device for Use by Physicians on Lesions Suspicious for Skin Cancer The Food and Drug Administration (FDA) is classifying the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer into class II. The special controls t more PR

Federal Register: FDA Reclassifies Imvaria Inc. Fibresolve Software for Lung Disease Referral, Establishing Special Controls (10)
WASHINGTON, Oct. 31 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register. * * * Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease The Food and Drug Administration (FDA) is classifying the radiology software for referral of findings related to fibrotic lung disease into class II. The special controls that apply to the device type are identified in this order and will be pa more PR

Federal Register: FDA Reclassifies IntuiTap Medical Spinal Imaging System to Expand Access to Neuraxial Procedure Tech (10)
WASHINGTON, Oct. 31 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register. * * * Medical Devices; Anesthesiology Devices; Classification of the Spinal Imaging System for Neuraxial Procedures The Food and Drug Administration (FDA) is classifying the spinal imaging system for neuraxial procedures into class II. The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the s more PR

Federal Register: FDA Reclassifies Over-the-Counter Sleep Apnea Risk Assessment Devices to Expand Patient Access (10)
WASHINGTON, Oct. 31 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register. * * * Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea The Food and Drug Administration (FDA) is classifying the over-the-counter device to assess risk of sleep apnea into class II. The special controls that apply to the device type are identified in this order and will be part of the codified language for classific more PR

Federal Register: FDA Replaces 2024 Draft Guidance to Update Testing, Performance Frameworks for Combination Drug Delivery Devices (10)
WASHINGTON, Oct. 31 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register. * * * Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; Revised Draft Guidance for Industry; Availability The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and more PR

McGill University Medicine Professor Heroux Calls for Broader Research and Mitigation of Electromagnetic Radiation Health Effects (10)
WASHINGTON, Nov. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. 2026-10-19 I am a professor of Health Effects of Electromagnetism at the Faculty of Medicine, McGill University, Montreal, Canada. I have served on the New Hampshire Committee on the Environmental and Health Effects of Evolving 5G Technology (2020). I am currently part of the HHS Committee reviewing Scientific Evidence, Regulatory Analysis, and Policy Recommendations on more ST

NH Healthy Climate Urge EPA to Reject Clean Air Act Rollback on Power Plant Climate Pollution (10)
WASHINGTON, Nov. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. NH Healthy Climate (Formerly NH Healthcare Workers for Climate Action) PO Box 426, Manchester NH, 03105 www.nhclimatehealth.org Info@nhclimatehealth.org Comment to the U.S. EPA on the "Proposed Rescission of the Greenhouse Gas Findings for Fossil Fuel-Fired Power Plants and Repeal of Regulations for Power Plant Greenhouse Gas Emissions Under Clean Air Act Section 111"  more ST

PharmedOut Urges FDA to Reject Testosterone Approval for Women Without Safety and Efficacy Evidence (10)
WASHINGTON, Nov. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. October 16, 2026 Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Docket No. FDA-2026-N-5479 PharmedOut, a rational prescribing project at Georgetown University Medical Center, supports the Food and Drug Administration's (FDA) current position on testosterone use in women as presented on September 17, 2026, at the FDA Public Meeting: more ST