Which federal agency does Advanced Medical Technology Association comment on most?

Advanced Medical Technology Association is most active at the Food and Drug Administration.

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Advanced Medical Technology Association

Unclaimed

Industry

Medical Devices

Staff

170

1301 Pennsylvania Ave NW, Washington, DC

Phone

+1 202-783-8700

Website

advamed.org

Engagement overview

Advanced Medical Technology Association has filed 548 public comments across 432 dockets at 19 federal agencies, most actively at the Food and Drug Administration.

Advanced Medical Technology Association

Engagement overview

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Agency footprint

Dockets (432)

National Emission Standards for Hazardous Air Pollutants: Commercial Ethylene Oxide Sterilization Technology Review

Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity

Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments -- Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices.

Request For Public Comment: Measuring and Evaluating Artificial Intelligence-enabled Medical Device Performance in the Real-World.

Food and Drug User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Years Proposed Guidance Developments

Phasedown of Hydrofluorocarbons: Reconsideration of Certain Regulatory Requirements Promulgated Under the Technology Transitions Provisions of the American Innovation and Manufacturing Act of 2020

Request for Comments on Significant Foreign Trade Barriers for the 2026 National Trade Estimate Report

Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Personal Protective Equipment, Medical Consumables, Medical Equipment, and Their Parts and Components

Request for Comments and Notice of Public Hearing China's Compliance with World Trade Organization Commitments

Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers

Electronic Submission Template for Medical Device Q-Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry; Availability

Recommendations to Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry; Availability

Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Processed Critical Minerals and Derivative Products

Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry; Availability

Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products

Proposed Modifications to the HIPAA Security Rule to Strengthen the Cybersecurity of ePHI

Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity

Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; Availability

The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability

Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling

Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Request for Comments: Significant Foreign Trade Barriers for the 2025 National Trade Estimate Report

Application for Assessment of Environmental Performance Standards and Ecolabels for Potential Inclusion in EPA’s Recommendations for Federal Purchasing; Notice of Public Webinar for Potential Applicants

Health Equity for Medical Devices

Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products; Draft Guidance for Industry; Availability

Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability

Request for Comments and Notice of Public Hearing Concerning China’s Compliance with WTO Commitments

Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

Request for Comments on Americas Partnership for Economic Prosperity – Trade Track

Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry; Availability

Provisions Pertaining to U.S. Investments in Certain National Security Technologies and Products in Countries of Concern

Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting

Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564; Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Availability

Medical Device Servicing and Remanufacturing Activities; Public Workshop; Request for Comments

Patent Trial and Appeal Board Rules of Practice for Briefing Discretionary Denial Issues, and Rules for 325(d) Considerations, Instituting Parallel and Serial Petitions, and Termination Due to Settlement Agreement

Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA) Reporting Requirements

Virtual Public Workshop – Accreditation Scheme for Conformity Assessment Expansion

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Key Information and Facilitating Understanding in Informed Consent for FDA-Regulated Clinical Investigations; Draft Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards; Availability

Collection of Race and Ethnicity Data in Clinical Trials

Establishment & Operation of Clinical Trial Monitoring Comm

Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry; Availability

Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance; Availability

CDRH Seeks public comment: Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes

Exemptions to Permit Circumvention of Access Controls on Copyrighted Works

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Petition for Rulemaking of PIRG and iFixit

Workshop to Enhance Clinical Study Diversity; Public Workshop; Request for Comments

Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices

Medical Devices; Laboratory Developed Tests

Evidentiary Expectations for 510(k) Implant Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Electronic Submission Template for Medical Device De Novo Requests; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Recently Posted ONCD Rules and Notices.

Cybersecurity Regulatory Harmonization RFI

Virtual Public Workshop – Patient-Reported Outcomes and Vision Related Quality of Life Questionnaires

Modernizing the Recall Process

U.S. Investments in Certain National Security Technologies and Products in Countries of Concern

Oncology Drug Products Used With Certain In Vitro Diagnostic Tests: Pilot Program; Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff; Availability

Request for Comments and Notice of Public Hearing Concerning China’s Compliance with WTO Commitments

FDA Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies

Health Breach Notification Rule

Decentralized Clinical Trials for Drugs, Biological Products, and Devices; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability

Marketing Submission Recommendations for a Modification Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Ethylene Oxide (ETO) Registration Review Docket

Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability