FDA

MDMA has been working closely with FDA’s Center for Devices and Radiological Health (CDRH) and Congress to ensure milestones and commitments included in MDUFA III are being met, and that the premarket review process is more predictable, transparent and reasonable.

MDMA has also been involved in the effort to protect all industry funded user fees from sequestration.

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

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FDA Issues Draft Guidance on Evaluation and Reporting of Age, Race, Ethnicity Data in Medical Device Clinical Studies

The Food and Drug Administration (FDA) released draft guidance today titled...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 ….