Tuesday, March 28, 2023

cranial helmets (summery of replies) #2

original post:

I was wondering what the current status is in my ability to fit pediatric

cranial helmets. The last I heard, the FDA has regulated the procedure and

limited its production/provision to just one company. Has everyone else in

the US stopped providing this service? Does this mean that I, as a licensed

and certified practitioner cannot provide this orthotic device in my local

community? I would love to hear feedback on how it has affected other

practitioner practices? Does anyone else provide an alternative device? Are

there any legal ways to work around the FDA regulation?

Thanks in advance.

Wade Bader, CPO

Tampa, FL

Summery #2:

I had a call to make one today and called the manufacturers of DOCS band,

they will not sell to anyone and are opening satellites all over the states

and are the only company that is FDA approved (talk about a monopoly).

Please let me know if you find any other info.

I thought as orthotists, we were able to make custom devices without FDA

approval, but that seems to have changed, Maybe soon we will no longer be

able to make custom knee orthoses?


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