Public Comments on FDA’s Medical Devices Commitment letter

Members of the Patient, Consumer, and Public Health Coalition are pleased to provide public comments on the Medical Device User Fee Amendments (MDUFA) V Commitment letter. We are very concerned about the process and the Commitment letter.

The Patient, Consumer, and Public Health Coalition is an informal coalition of nonprofit organizations representing the interests of millions of patients, consumers, health-care professionals, scientists, public health experts, and advocates. 

The negotiations between the Food and Drug Administration (FDA) and medical device industry were not transparent and excluded patients, consumers, and other stakeholders. To make matters worse, the meeting minutes from the latter half of 2021 and all of 2022 were not publicly available.

The FDA’s proposed Commitment letter has already been delivered to Members of Congress, and the House Energy & Commerce Subcommittee on Health held a hearing on its content on March 30, 2022. It seems much too late to ask for written comments three weeks later.

As numerous patient and consumer groups have told CDRH previously, the Commitment Letter focuses on fees and speed, and does not include safeguards for patients in either the pre-market or post-market period. Performance measures focused on device safety and effectiveness are omitted, as are performance measures focused on diversity.

It is especially harmful to patients and consumers that the Commitment Letter requires very speedy premarket review but does not provide user fees for post-market surveillance. 

Congress has required that stakeholders have the opportunity to participate in the MDUFA V reauthorization process. FDA is following the letter of the law, by scheduling meetings with stakeholders. But they are ignoring the spirit of the law by not including patients’ and consumers’ and public health experts’ views in the MDUFA V Commitment letter. 

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