Years ago, U.S. patients all too often were not the first to get access to medical technology innovations developed in the United States. MDMA gathered data to quantify the problem and advocated for least-burdensome, risk-based solutions. Regulatory programs improved, and MDMA continues to advocate for additional enhancements and improvements to the premarket review programs to ensure that U.S. patients receive timely access to safe and effective medical technologies.
MDMA is working with FDA, Congress and various stakeholders to help ensure that the milestones and commitments included in the most recent user fee reauthorization are met, and that the regulatory pathways are predictable, reasonable and transparent.
The
FDA Working Group typically meets on the 1st Tuesday of each month
at 2pm ET via teleconference. If you would like to join this working group,
click here.
Latest News
FDA Issues Final Guidance on Artificial Intelligence-Enabled Device Software Functions
FDA today issued the final guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions"...
MDMA Files Comments to FDA on Predetermined Change Control Plans for Medical Devices
MDMA filed comments today on FDA's draft guidance, "Predetermined Change Control Plans for Medical Devices." The draft guidance is...
FDA Hosts Public Workshop on Biocompatibility for Medical Devices
The FDA hosted a public workshop today entitled, “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices"...
FDA Implements Reorganization Aimed to Enhance Collaboration
In January 2023, the FDA announced that it would develop a reorganization proposal that would allow for the creation of a unified Human Foods Program and restructure...
MDMA Files Comments to FDA on Draft Guidance Regarding Diversity Action Plans
MDMA submitted comments today to FDA on the draft guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies...
Shuren Departing CDRH, Dr. Michelle Tarver to Serve at Acting Director
CDRH Director Jeff Shuren announced today that he will be stepping down as CDRH Director and that Dr. Michelle Tarver will become...
Representatives Seek Stakeholder Input on 21st Century Cures Initiative
Representatives Diana DeGette (CO) and Larry Bucshon (IN) today issued a letter seeking information from stakeholders on what Congress can do to further the goals of the 21st Century Cures initiative...
FDA Center Directors Testify Before E&C Health Subcommittee
The House Energy & Commerce’s Health Subcommittee held a hearing today entitled “Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices.”...
Bipartisan Senate Group Releases Roadmap for Artificial Intelligence
A Bipartisan Senate AI Working Group, led by Majority Leader Chuck Schumer (NY) and Senators Mike Rounds (SD), Martin Heinrich (NM) and Todd Young (IN), unveiled...
Senate Appropriations Subcommittee Examines FY 25 Budget Request for FDA
FDA Commissioner Robert Califf appeared before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies today as it held a hearing...
FDA Releases Long-Awaited Laboratory Developed Tests Final Rule
The FDA today released its long-awaited Laboratory Developed Tests (LDT) final rule. The final rule amends the FDA’s regulations to clarify that in vitro diagnostics (IVDs)...
HHS Releases White Paper Spotlighting Supply Chain Vulnerabilities
The U.S. Department of Health and Human Services (HHS) released a white paper today highlighting steps HHS has taken to prevent and mitigate drug shortages and...
House Committee Examines FDA’s Proposed Rule on LDTs
The House Energy and Commerce Subcommittee on Health held a hearing today entitled, “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule"...
EPA Issues Final Rule Detailing New Provisions on EtO Sterilization
The EPA issued a final rule today to provide new regulations and restrictions regarding the use of ethylene oxide (EtO) for the sterilization of medical devices...
House of Representatives Advances Appropriation Bills, Including Funding for FDA
The House of Representatives passed a six-bill minibus today by a 339-85 vote...
MDMA Submits Comments to FDA Regarding Potential Supply Chain Disruptions in the Medical Device Industry
MDMA filed comments to the Food and Drug Administration today in response to the draft guidance...
MDMA Participates in FDA Panel Examining Potential Supply Chain and Shortage Issues
Members of the FDA's General Hospital and Personal Use Devices Panel convened today to examine...
MDMA Files Comments to FDA on the Use of Real-World Evidence
MDMA filed comments today with FDA in response to the draft guidance...
FDA Issues QMSR Final Rule, Announces Intent to Reclassify Certain Diagnostics
The FDA today issued the Quality Management System Regulation (QMSR) final rule...
FDA Hosts First in a Series of Town Hall Meetings to Discuss EtO
The FDA held the first in a series of town hall meetings today to discuss the potential...
Lawmakers Examine Artificial Intelligence and Health IT, HHS Issues and a New Rule
The Energy and Commerce Committee examined issues today related to Artificial Intelligence (AI)...
MDMA Submits Comments on FDA's Draft Guidance for Predicate Devices, Laboratory Developed Tests Proposed Rule
MDMA submitted comments today on the draft guidance, "Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission"...
FDA Announces Digital Health Advisory Committee, Seeks Advisory Members
The FDA announced today that it will create a new Digital Health Advisory Committee...
CDRH Posts List of Proposed Guidances for the Remainder of Fiscal Year 2024
CDRH today issued a list of guidances it intends to publish during the remainder of FY2024.
FDA Issues Cybersecurity in Medical Devices Final Guidance
FDA issued the final guidance today, "Cybersecurity in Medical Devices: Quality System Considerations and the Content of Premarket Submissions"
MDMA Shares Input with FDA on Increasing Access to At-Home MedTech
MDMA responded to Center for Devices and Radiological Health’s (CDRH’s) request for public comments today
Senate Appropriations Committee Passes Fiscal Year 2024 Labor-HHS Spending Bill
The Senate Appropriates Committee held a markup today of several Fiscal Year (FY) 2024
MDMA Submits Comments to FDA on Advancing Real-World Data and Real-World Evidence
MDMA
filed comments today in response to the U.S. Food and Drug
Administration’s (FDA’s) recently issued the draft guidance, “Content of
Human Factors Information in Medical Device Marketing Submissions."
MDMA Submits Comments to FDA on Human Factors Draft Guidance
MDMA filed comments in response to the request for input regarding “FDA’s Advancing Real-World Data and Real-World Evidence with User Fee Funding.” MDMA has actively supported the advancement of real-world evidence (RWE)...
MDMA Files Comments on FDA’s Resilient Supply Chain Program
MDMA filed comments to the Food and Drug Administration (FDA) today regarding the June Public Workshop on the Resilient Supply Chain Program (RSCP)...
MDMA Submits Comments on FDA’s Proposal to Amend the Medical Device Quality System Regulation
MDMA filed comments to the Food and Drug Administration (FDA) today on their proposed rule, “Medical Devices; Quality System Regulation Amendments.”
House E&C Advances UFA Reauthorization Package, Senate HELP Releases UFA Discussion Draft
On Wednesday, the House Energy and Commerce (E&C) Committee held a markup of several bills, including legislation that provides reauthorization of MDUFA...
MDMA
Testifies at Senate Hearing on MDUFA V Draft Agreement, FDA Announces MDUFA
Public Meeting Date
The
Senate Committee on Health, Education, Labor & Pensions (HELP) held a hearing today titled, “FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation
for the Benefit of Patients”...
MDMA
Testifies at House Hearing on MDUFA, Set to Testify in Senate Next Week
The
House Energy & Commerce (E&C) Health Subcommittee held a hearing today to examine
the fifth Medical Device User Fee Amendments agreement (MDUFA V)...
MDMA Statement on Dr. Robert Califf's Nomination as the Next FDA Commissioner
MDMA President & CEO, Mark Leahey issued the following statement today regarding the nomination of Dr. Robert Califf as the next Commissioner of the Food and Drug Administrations (FDA)...
MDMA Statement on the Release of “Cures 2.0” Draft Legislation
Mark Leahey, President and CEO of MDMA, issued the following statement regarding the release of a “Cures 2.0” draft legislation by Congresswoman Diana DeGette (CO) and Congressman Fred Upton (MI)...
MDMA Statement on the Senate Confirmation of Xavier Becerra as HHS Secretary
Mark Leahey, President & CEO of MDMA, issued the following statement today regarding the Senate confirmation...
MDMA Hosts Successful Virtual FDA Forum
MDMA hosted another successful FDA Forum with nearly 200 participants, learning first-hand from top FDA officials and other experts...
MDMA Statement on Public Meeting for User Fee Reauthorization
MDMA's President and CEO Mark Leahey issued the following statement today regarding the first public stakeholder meeting to discuss the reauthorization of the Medical Device User Fee Act (MDUFA)...
FDA Issues Guidance on Notifications to Help Prevent or Mitigate Medical Device Shortages
The “CARES Act” that was signed into law on March 27 included a provision related to medical device shortages...
MDMA Statement on the Senate Confirmation of Hahn as FDA Commissioner
Mark Leahey, President and CEO of MDMA, issued the following statement today regarding Dr. Stephen Hahn’s confirmation by the Senate to be the next FDA Commissioner...
FDA Releases Final Guidance Modernizing the 510(K) Pathway
The U.S. FDA
announced new steps today that it will take to strengthen the 510(k) regulatory pathway...
MDMA's Statement on FDA’s Plan to Modernize the 510(k) Regulatory Pathway for Medical Devices
Mark Leahey, President and CEO of MDMA, issued the following statement today in response to FDA’s plan to
modernize the 510(k) regulatory pathway for medical devices...
MDMA Statement on the ICIJ Coverage of Medical Devices
Mark Leahey, President and CEO of MDMA, issued the following statement today in response to the ICIJ coverage of medical devices and the regulatory pathways...
MDMA Statement on FDA’s Updates to the “
Medical Device Safety Action Plan”
Mark Leahey, President and CEO of MDMA, issued the following statement today in response to FDA’s updates to their “
Medical Device Safety Action Plan
”...
MDMA Statement on FDA’s “Medical Device Safety Action Plan”
Mark Leahey, President and CEO of MDMA, issued the following statement today in response to FDA’s “
Medical Device Safety Action Plan” that was released by Commissioner Scott Gottlieb...
Mark Leahey, President and CEO of MDMA, issued the following statement today on the Senate confirmation of Alex Azar to be the next Secretary of HHS...
MDMA President and CEO Mark Leahey issued the following statement today regarding the passage of MDUFA reauthorization in the Senate...
MDMA President and CEO Mark Leahey issued the following statement today regarding the passage of MDUFA reauthorization in the House of Representatives...
MDMA Statement on Scott Gottlieb's Confirmation as the Next FDA Commissioner
Mark Leahey, President and CEO of MDMA, issued the following statement regarding Dr. Scott Gottlieb's confirmation as the next FDA Commissioner...
MDMA Board Member Testifies Before House Committee Examining Medical Device User Fees
MDMA Board Member and Founder of CVRx, Robert Kieval testified during today's House E&C Health Subcommittee hearing examining FDA's Medical Device User Fee Program...
MDMA Statement on HELP Committee Hearing on User Fees
MDMA issued the following statement today regarding the Senate HELP Committee hearing to examine the user fee agreements...
MDMA Statement on the Nomination of Scott Gottlieb to Lead the FDA
MDMA issued the following statement today regarding Dr. Scott Gottlieb's nomination as new FDA Commissioner...
MDMA Statement on Dr. Price's Confirmation as HHS Secretary
MDMA issued the following statement today following Dr. Price's confirmation...
FDA Issues Draft Guidance on Medical Device Software
FDA issued draft guidance for software that is designed to serve medical purposes...
MDMA Statement on Tentative User Fee Agreement
MDMA issued the following statement today regarding the release of meeting minutes...
New Medical Device User Fee Agreement Sets the Stage for Continued Progress in FDA Performance
MDMA, AdvaMed & MITA today announced that a tentative agreement has been reached...
FDA Issues Draft Guidance on Evaluation and Reporting of Age, Race, Ethnicity Data in Medical Device Clinical Studies
The Food and Drug Administration (FDA) released draft guidance today titled...
Senate HELP Advances Seven Bills in Second Innovation Markup
The Senate Health, Education, Labor, and Pensions (HELP) Committee held the second in a series of three hearings....
Senators Introduce Bipartisan Legislation to Streamline Medical Approval Process
Senators Cory Gardner (CO) and Joe Donnelly (IN) recently introduced...
President Nominates Califf as New FDA Commissioner
The White House recently announced the nomination of Dr. Rob Califf, currently Deputy Commissioner...
MDMA Statement on 21st Century Cures Discussion Draft
MDMA issued the following statement today in response to the latest "21st Century Cures" discussion draft...
Outgoing Food and Drug Administration (FDA) Commissioner Margaret Hamburg testified before the Senate Health, Education, Labor & Pensions (HELP)...
House & Senate Leaders Release FY 2016 Budget Proposals
House Budget Committee Chairman Tom Price (GA) and Senate Budget Committee Chairman Mike Enzi (WY) released their respective Committees' Fiscal Year...
FDA Issues Final Guidance: Pre & Postmarket Data Collection & Expedited Access Pathway Program
This week the Food and Drug Administration (FDA) issued two final guidance documents that, according to FDA, will "facilitate timely access to important new technology...
MDMA Statement on 21st Century Cures Discussion Draft
Mark Leahey, President & CEO of MDMA issued the following statement in response...
MDMA Statement on Device Tax Repeal and User Fee Language in Budget Deal
"MDMA applauds the continuing bipartisan support for putting an end to the medical device tax. With each passing day, this onerous policy impedes innovation, thwarts patient care and destroys jobs. We have much more work to do..."
Bill to Exempt FDA User Fees from Sequestration Introduced
in the Senate
Senator
Mark Pryor (AR) introduced a bipartisan bill today,the FDA Safety and User Fee Protection Act,
which would exempt user fees paid by medical device and pharmaceutical
companies…
MDMA Applauds Bipartisan
Legislation to Exempt FDA User Fees from Sequestration
In a
letter to lead cosponsors today, MDMA issued its strong support for the "FDA
Safety Over Sequestration Act,” or "FDA SOS Act,” introduced by Representatives
Leonard Lance (NJ), Anna Eshoo (CA)….
FDA Issues Draft Guidance
on Cybersecurity Concerns & Revised IDE Clinical Investigations
The
Food and Drug Administration (FDA) announced the issuance of two sets of draft
guidance this week. While there have been no reports of patients being hurt by
security failures, the first set, "Content of Premarket Submissions for
Management of Cybersecurity in Medical Devices," is intended to tighten
cyber security concerns ….
