Which federal agency does Medical Imaging & Technology Alliance comment on most?

Medical Imaging & Technology Alliance is most active at the Food and Drug Administration.

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Medical Imaging & Technology Alliance

Unclaimed

Industry

Hospital & Health Care

Staff

1300 17th St N, Arlington, Virginia

Phone

+1 703-841-3200

Website

medicalimaging.org

Engagement overview

Medical Imaging & Technology Alliance has filed 162 public comments across 133 dockets at 12 federal agencies, most actively at the Food and Drug Administration.

Medical Imaging & Technology Alliance

Engagement overview

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Agency footprint

Dockets (133)

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

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development; Draft Guidance for Industry; Availability

Exemptions to Permit Circumvention of Access Controls on Copyrighted Works

Accessibility Standards for Medical Diagnostic Equipment

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a Modification Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Secure Software Development Attestation Common Form

Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing

Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

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

Request for comments on Helium Supply Risk

Energy Labeling Rule

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

Nondiscrimination in Health Programs and Activities

Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry; Availability

Public Workshop – Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration

Accreditation Scheme for Conformity Assessment of Medical Devices to FDA-Recognized Standards

Current Good Manufacturing Practice for Positron Emission Tomography Drugs

Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments

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

Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) - Discussion Paper and Request for Feedback

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

Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Compliance Date Extension

Generic Drug User Fee Amendments; Public Meeting; Request for Comments

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

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

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

Procedures for Handling Section 522 Postmarket Surveillance Studies

Federal Registers, Written and Electronic Submissions (that do not include a Docket Number or ID_2021)

Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically- Powered Medical Devices

Exemptions to Permit Circumvention of Access Controls on Copyrighted Works

Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework

Advisory Committee on Immunization Practices (ACIP); December 18 and 20

Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

Prescription Drug User Fee Act

Public Workshop - Evolving Role of Artificial Intelligence in Radiological Imaging

Center for Devices and Radiological Health (CDRH): COVID-19

Clinical and Patient Decision Support Software

Safer Technologies Program for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Request for Information: Reducing Administrative Burden to put Patients over Paperwork (CMS-6082-NC)

Clinical Investigations for Prostate Tissue Ablation Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2020 Rates CMS-1716-P

Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser and Ultrasonic Products (proposed rule)

Mammography Quality Standards Act Requirements

Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Modernizing FDA’s 510(k) Program; Establishment of a Public Docket; Request for Comments

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Fostering Medical Innovation: A Plan for Digital Health Devices; Software Precertification Pilot Program

Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format; Companion to Direct Final Rule.

FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices In accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA)

MedWatch: The Food and Drug Administration Medical Products Reporting Program

CY 2019 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates CMS-1695-P

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

Fulfillment of 21st Century Cures Act Section 3060 Required Report

Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Notice of Determination and Request for Public Comment Concerning Proposed Determination of Action Pursuant to Section 301

The Least Burdensome Provisions: Concept and Principles

Center for Devices and Radiological Health; Medical Devices and Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers

Review of Existing Center for Devices and Radiological Health Regulatory and Information Collection Requirements

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations

Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program (CMS-1676-)

Medical Imaging Drugs Advisory Committee

Medicare Program; CY 2018 Updates to the Quality Payment Program (CMS-5522-P, CMS-5522-FC, CMS-5522-IFC)

Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2018 Rates CMS-1677-P

CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates CMS-1656-P

Medical X-Ray Imaging Devices Conformance with IEC Standards

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

Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)

Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models (CMS-5517-P)

Display Devices for Diagnostic Radiology

Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices performed by Third-party entities and Original Equipment Manufacturers

Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability