CRE Editorials

January 22, 2022

The comment period for the OTC hearing  aid NPRM has closed. FDA will now embark upon the task of reviewing and distilling in excess of 1,000 submissions,

CRE believes prior to addressing program issues specific to the regulation, such as the standard for the output of hearing aids, that the FDA first address macro concerns such as the complete non-compliance with two governing statutes: (1) the National Technology Transfer and Advancement Act and (2)  the Information Quality Act, both of which are discussed in this public comment and so identified as a Tier I issue.

It should be noted that unlike many other rulemakings the aforementioned  governing statues, coupled with OMB Circular A-119,  are ones that vest  shared decision-making authority over the contents of the final rule between FDA and OMB.

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