URGENT: Subject: AOPA Obtains Favorable Protective Helmet Ruling
Eliska Poirier
Description
Collection
Title:
URGENT: Subject: AOPA Obtains Favorable Protective Helmet Ruling
Creator:
Eliska Poirier
Date:
10/19/2000
Text:
AOPA is pleased to announce that it has obtained a favorable ruling from the
FDA regarding the classification of protective helmets. This was in
response to a Citizen's Petition AOPA sent to the FDA in March of this year,
arguing that these helmets should be classified at the lowest level (Class
I) for regulatory purposes and exempt from 510(k) requirements. In its
response, the FDA agreed with our position, stating in part When intended
solely for protection, the FDA agrees that the cranial helmet is a Class I
device...and is exempt from the premarket notification procedures...and good
manufacturing practice regulations...
Concerning the plagiocephalic (shaping) helmets, we are still waiting on a
response to our latest letter to the FDA, which argues that we are service
providers rather than manufactures. As soon as we receive a response, we
will publish it.
Kathy Dodson
Director of Reimbursement Services
AOPA
Eliska Poirier
Membership and Marketing Manager
American Orthotic and Prosthetic Association
1650 King Street, Suite 500
Alexandria, VA 22314
(Ph)703-836-7116 (Fx)703-836-0838
<Email Address Redacted>
www.aopanet.org
FDA regarding the classification of protective helmets. This was in
response to a Citizen's Petition AOPA sent to the FDA in March of this year,
arguing that these helmets should be classified at the lowest level (Class
I) for regulatory purposes and exempt from 510(k) requirements. In its
response, the FDA agreed with our position, stating in part When intended
solely for protection, the FDA agrees that the cranial helmet is a Class I
device...and is exempt from the premarket notification procedures...and good
manufacturing practice regulations...
Concerning the plagiocephalic (shaping) helmets, we are still waiting on a
response to our latest letter to the FDA, which argues that we are service
providers rather than manufactures. As soon as we receive a response, we
will publish it.
Kathy Dodson
Director of Reimbursement Services
AOPA
Eliska Poirier
Membership and Marketing Manager
American Orthotic and Prosthetic Association
1650 King Street, Suite 500
Alexandria, VA 22314
(Ph)703-836-7116 (Fx)703-836-0838
<Email Address Redacted>
www.aopanet.org
Citation
Eliska Poirier, “URGENT: Subject: AOPA Obtains Favorable Protective Helmet Ruling,” Digital Resource Foundation for Orthotics and Prosthetics, accessed November 4, 2024, https://library.drfop.org/items/show/215252.
