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 · FDA (98)

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development; Draft Guidance for Industry; Availability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for a Modification Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

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

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

Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry; Availability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FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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

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

Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework

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

Clinical Investigations for Prostate Tissue Ablation Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

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

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

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

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

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

Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations

Medical Imaging Drugs Advisory Committee

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

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

Postmarket Management of Cybersecurity in Medical Devices

Public Notification of Emerging Postmarket Medical Device Signals Emerging Signals

Collaborative Approaches for Medical Device and Healthcare Cybersecurity; Public Workshop; Request for Comments

Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices

Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance Environment for Multi-Configuration Passive Medical Devices

Office of the Commissioner; Request for Comments on the Food and Drug Administration Fiscal Year 2014-2018 Strategic Priorities Document; Request for Comments

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

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

Joint Meeting of the Gastroenterology-Urology Panel and the Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

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

Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Comprehensive Assessment of the Process for the Review of Device Submissions; Request for Comments

Unique Device Identification System

Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability

Investigational New Drug Applications for Positron Emission Tomography Drugs; Draft Guidance

Draft Guidance for Industry and Food and Drug Administration Staff; The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k); Availability

Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed; Request for Information and Comments

FDA Transparency Task Force; Public Meeting

Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability

FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations