Dear Practitioners:
Word on the street is that many O&P facilities have started submitting a
510(k) to manufacture cranial helmets. Would you please let me know if you:
a. have submitted paperwork
b. are in the process of preparing parperwork to submit
c. have submitted and have received approval.
I would also be interested in hearing of any direct contact you may have had
with FDA (or vice versa) on this issue.
Tom Gorski, CAE
Executive Director
American Academy of Orthotists and Prosthetists
