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
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?