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 · FDA (347)

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

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Electronic Submission Template for Medical Device Q-Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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

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Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry; Availability

Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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

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

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

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

Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry; Availability

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

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

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

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

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

Modernizing the Recall Process

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

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

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

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

Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11--Questions and Answers; Draft Guidance for Industry; Availability

FDA Seeks Public Comment: Advancing Real-World Data and Real-World Evidence with User Fee Funding

List of Highest Priority Devices for Human Factors Review

Circumstances that Constitute Delaying, Denying, Limiting or Refusing a Drug or Device Inspection

Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

TPLC Advisory Program Pilot Soft Launch

Public Workshop –Appropriate Use of Consensus Standards

Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards

Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Ethical Considerations for Clinical Investigations of Medical Products Involving Children; Draft Guidance for Industry, Sponsors, and IRBs; Availability

Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability

Medical Devices; Quality System Regulation Amendments

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability

Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Discussion Paper: 3D Printing Medical Devices at the Point of Care

Content of Premarket Submissions for Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Electronic Submission Template for Medical Device 510(k) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Genus Medical Technologies LLC Versus United States Food and Drug Administration; Request for Information and Comments

Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry; Availability

Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities