NPRM: CRE Background Submission

Center for Regulatory Effectiveness

A Select Quotation

“A review of the record for the FDA NPRM on OTC Hearing Aids reveals a wide disparity in the data submitted by interested parties. To assist readers in developing their comments on the NPRM we are providing for easy reference four critical documents dealing with the topic being addressed in the NPRM.

We suggest that commenters read the aforementioned documents, which are included in this submission, as they prepare their comments on the NPRM. The commenters should then attempt to ascertain why the FDA adopted a standard recommended by a trade association without the slightest recognition of the recommendations of two governmental organizations, so referenced herein,

We understand that there was considerable input from Members of Congress to have the regulations issued in a timely manner but we are not aware of any suggestions made by Members of Congress on the content of the regulation, Therefore, we are puzzled on how and why this proposal made it through the regulatory review process of the Biden Administration.”

Jim Tozzi


Leave a Reply