Saturday, May 21, 2022

Cranial Helmet (summery of replies) #1

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

Replies (in order they came in):

Well i can tell you in Orlando Hanger is doing them I would love to find out

it is not legal

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