March 4, 2022: We write today to follow up on your response to several requests for information at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Medical Device User Fee Amendments (MDUFA V) stakeholders meeting on February 28, 2022.
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NCHR Comments on the MDUFA V Commitment Letter
April 21, 2022: NCHR would like to express our substantial concerns with the overall process as well as the shortcomings of the Commitment letter.
Read More »Nonprofit Consumer and Public Health Organization’s Letter on MDUFA reauthorization to FDA and CDRH
February 22, 2022: We strongly urge the FDA to hold firm in the demands to strengthen pre- and post-market safety performance measures and surveillance as part of the MDUFA Commitment Letter as you enter into final negotiations with industry. MDUFA performance goals should include metrics regarding safety, and not just speed of review.
Read More »Testimony of Dr. Diana Zuckerman, NCHR, at the FDA MDUFA Meeting
September 30, 2021: Dr. Diana Zuckerman testifies to the FDA regarding the lack of diversity and inclusion in medical device trials pointing out that most medical companies do not adequately study safety and effectiveness in women, older patients, and people of color.
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