The pundits are wrong. The FDA follows the instructions given to them by Congress.
What went right is that there was broad bipartisan support for the 2017 FDA reauthorization act which permitted them to do this.
What went wrong was that covid delayed the rule making process by about 18 months.
Every single rule/regulation in the Code of Federal Regulations can be traced back to a law that originated in Congress with the words "the Secretary shall..." in it, with the secretary being the head of a government agency.
Prior to 2017 the Congress said "the Secretary shall regulate medical devices" and under the definition created by Congress hearing aids were medical devices, so the FDA did.
After 2017 the Congress said "the Secretary shall regulate medical devices but also make a category for OTC hearing aids" so the FDA did.
Also, rule changes take a long time either because of changes in the laws telling federal agencies what to do or laws already in 5 U.S. Code that define the rule-making process.
There are many federal agencies that would like to wave their hands and create or eliminate rules but for better or worse (I think mainly better) they can't.
Many, though not all, pundits don't realize what the process is.
The pundits are wrong. The FDA follows the instructions given to them by Congress.
What went right is that there was broad bipartisan support for the 2017 FDA reauthorization act which permitted them to do this.
What went wrong was that covid delayed the rule making process by about 18 months.
Every single rule/regulation in the Code of Federal Regulations can be traced back to a law that originated in Congress with the words "the Secretary shall..." in it, with the secretary being the head of a government agency.
Prior to 2017 the Congress said "the Secretary shall regulate medical devices" and under the definition created by Congress hearing aids were medical devices, so the FDA did.
After 2017 the Congress said "the Secretary shall regulate medical devices but also make a category for OTC hearing aids" so the FDA did.
Also, rule changes take a long time either because of changes in the laws telling federal agencies what to do or laws already in 5 U.S. Code that define the rule-making process.
There are many federal agencies that would like to wave their hands and create or eliminate rules but for better or worse (I think mainly better) they can't.
Many, though not all, pundits don't realize what the process is.