Information on Cranial Orhtoses
Kathy Dodson
Description
Collection
Title:
Information on Cranial Orhtoses
Creator:
Kathy Dodson
Date:
5/9/2001
Text:
Mr. Saunders:
This is in response to your questions concerning activities regarding the
FDA regulation of cranial helmets. I am responding to the listserve rather
than directly to you, since others may have similar questions. AOPA, rather
than the National Office (which was dissolved last year) was the group most
directly involved with this issue, which came to our attention in December
1999.
Our first step was to gather extensive information on the issue of FDA
regulation of custom cranial molding helmets. We worked with FDA personnel,
an FDA consultant and a law firm that specialized in FDA problems. From the
FDA we found out that cranial molding helmets are not categorized as
orthopedic devices, but rather as neurological devices due to the FDA's
concerns with child safety. This is the primary reason why these helmets
are treated differently from other orthoses. To give you a feel for the
mindset of the FDA, it stated It is the opinion of the FDA that cranial
bands and helmets, which are intended to reshape an infant's head, are
appropriately classified as a Class II medical device...The
requirements...provide a necessary measure of protection for the most
vulnerable and precious members of our society, our children.
The AOPA Government Relations Committee decided that we should request the
FDA to reclassify these helmets as Class I and exempt them from premarket
notification (510(k)) rules. This was formally requested in August of 2000.
While we were looking into the custom helmet issue, we also discovered that
the protective helmets were not classified, which means that by default,
they were Class III (the highest level of regulation.) Therefore, we also
petitioned the FDA to reclassify these device to Class I and 510(k) exempt
status.
In September of 2000 we received an affirmative response to our petition
regarding the protective helmets, in which the FDA agreed to classify them
as Class I and 510(k) exempt. However, in January of 2001, we received a
negative reply to our request to reclassify the molding helmets. This means
that in order to provide custom helmets, a facility must either register
with the FDA and submit 510(k) information for approval, or use a
manufacturer that has already successfully completed this process. There is
no formal appeal process available for such decisions.
We understand your concern regarding other O&P devices, however it is very
unlikely that the FDA will decide to re-review all of the hundreds of
devices that it has already classified as Class I and 510(k) exempt, since
as with most government agencies, it is backlogged and does not usually
search for extra work.
I hope this information is helpful. All of this information was distributed
to the AOPA membership in AOPA In Advance newsletters on the following
dates: Dec. 7 and 21, 1999, Jan. 11, Feb. 29, March 14, April 11 and 25,
June 20, Sept 12, and Oct. 17, 2000 and finally Jan. 23, 2001. Since your
facility is not an AOPA member, you unfortunately did not have access to
these publications. If you would like copies, please let me know. My phone
number is (703) 836-7116.
Kathy Dodson
Senior Director of Government Affairs
AOPA
This is in response to your questions concerning activities regarding the
FDA regulation of cranial helmets. I am responding to the listserve rather
than directly to you, since others may have similar questions. AOPA, rather
than the National Office (which was dissolved last year) was the group most
directly involved with this issue, which came to our attention in December
1999.
Our first step was to gather extensive information on the issue of FDA
regulation of custom cranial molding helmets. We worked with FDA personnel,
an FDA consultant and a law firm that specialized in FDA problems. From the
FDA we found out that cranial molding helmets are not categorized as
orthopedic devices, but rather as neurological devices due to the FDA's
concerns with child safety. This is the primary reason why these helmets
are treated differently from other orthoses. To give you a feel for the
mindset of the FDA, it stated It is the opinion of the FDA that cranial
bands and helmets, which are intended to reshape an infant's head, are
appropriately classified as a Class II medical device...The
requirements...provide a necessary measure of protection for the most
vulnerable and precious members of our society, our children.
The AOPA Government Relations Committee decided that we should request the
FDA to reclassify these helmets as Class I and exempt them from premarket
notification (510(k)) rules. This was formally requested in August of 2000.
While we were looking into the custom helmet issue, we also discovered that
the protective helmets were not classified, which means that by default,
they were Class III (the highest level of regulation.) Therefore, we also
petitioned the FDA to reclassify these device to Class I and 510(k) exempt
status.
In September of 2000 we received an affirmative response to our petition
regarding the protective helmets, in which the FDA agreed to classify them
as Class I and 510(k) exempt. However, in January of 2001, we received a
negative reply to our request to reclassify the molding helmets. This means
that in order to provide custom helmets, a facility must either register
with the FDA and submit 510(k) information for approval, or use a
manufacturer that has already successfully completed this process. There is
no formal appeal process available for such decisions.
We understand your concern regarding other O&P devices, however it is very
unlikely that the FDA will decide to re-review all of the hundreds of
devices that it has already classified as Class I and 510(k) exempt, since
as with most government agencies, it is backlogged and does not usually
search for extra work.
I hope this information is helpful. All of this information was distributed
to the AOPA membership in AOPA In Advance newsletters on the following
dates: Dec. 7 and 21, 1999, Jan. 11, Feb. 29, March 14, April 11 and 25,
June 20, Sept 12, and Oct. 17, 2000 and finally Jan. 23, 2001. Since your
facility is not an AOPA member, you unfortunately did not have access to
these publications. If you would like copies, please let me know. My phone
number is (703) 836-7116.
Kathy Dodson
Senior Director of Government Affairs
AOPA
Citation
Kathy Dodson, “Information on Cranial Orhtoses,” Digital Resource Foundation for Orthotics and Prosthetics, accessed May 17, 2024, https://library.drfop.org/items/show/216548.
