Announcement from the Academy
Manisha Sethi
Description
Collection
Title:
Announcement from the Academy
Creator:
Manisha Sethi
Date:
4/6/2000
Text:
This information is being provided to you by the American Academy of
Orthotists and Prosthetists:
CALL TO MEMBERSHIP
FOR INFORMATION & ACTION
ISSUE: Cranial Molding Helmets
BACKGROUND: As you may know, the Food and Drug Administration has classified
the D.O.C. Band (manufactured by Cranial Technologies, Phoenix, AZ) as a
Class II medical device. Additionally, the regulation applies this control
to all cranial orthoses used in the treatment of infants 3 to 18 months of
age with non-synostotic positional plagiocephaly. The implication is that
orthotists who currently design, fit, and fabricate these orthoses in their
practices must either do so under violation of federal law, stop providing
the orthoses, or complete the 510(k) process to become registered with the
FDA to provide these orthoses.
PROBLEM: Filing a 510(k) application - a lengthy and expensive process -
would require the tracking of certain processes and the application of
control mechanisms that an orthotist, not being involved in traditional
manufacturing processes, would be unable to provide without substantially
changing his or her business. This would cause a financial hardship that
would force many to abandon this segment of their practices. Thus, large
segments of the population, such as the infant on state welfare or the
low-income infant (markets not traditionally serviced by Cranial
Technologies) would be without care.
POSITION: It is the Academy's view that orthotists have been safely and
effectively designing, custom fabricating and fitting cranial molding
helmets to their prescribing physician's specifications for nearly 20 years.
These helmets are substantially equivalent to the devices described by
Clarren in 1979 and first provided in the mid-1970's. These Clarren style
helmets differ from the patented D.O.C.Bands by virtue of their passive
design. Devices in commercial distribution prior to 1976 are exempt from
regulation. Given the very close timing of the introduction of the first
helmet by Dr. Clarren to the May 28, 1976 exemption date, and given that the
Clarren helmet and the current delivery system have a historically safe
record, the Academy believes the helmets provided by our profession should
be deemed exempt.
PLAN: To file a petition with the FDA requesting that it consider this
position.
YOUR HELP NEEDED: We need letters to attach to this petition.
From orthotists:
We need letters endorsing this position and
indicating the approximate the number of helmets fit and mentioning when you
first began providing helmets.
From your referral sources:
We need letters endorsing this position,
indicating when they began prescribing helmets and emphasizing that they
consider the helmets provided to have been safe and effective.
PLEASE PREPARE YOUR LETTERS TO:
James Dillard, Deputy Director
Division of General and Restorative Devices
FDA, 350D
9200 Corporate Boulevard
Rockville, MD 20850
Please do not send your letters directly to Mr. Dillard. Rather, send them
to the Academy where we will compile them with the others for maximum
impact.
TIMELINE: This is really quite time sensitive. We realize that the FDA's
response will take some time, however we must submit promptly. Please
forward copies of your letter(s) by APRIL 30.
ADDITIONALLY: AOPA agrees it would be very helpful to write your Senator and
Congressman explaining this issue and requesting they contact the FDA in
support of our position. To obtain your Representatives' address visit the
AOPA website at www.aopanet.org and click on Government Relations -
Legislative Action Center.
SEND A COPIES OF YOUR LETTERS TO:
Thomas A. Gorski, CAE
Executive Director
American Academy of Orthotists and
Prosthetists
1650 King Street, Suite 500
Alexandria, Virginia 22314
ACKNOWLEDGEMENTS: The Academy would like to thank the Cranial Helmet Task
Force and AOPA for their assistance in this effort.
Thomas A. Gorski, CAE
Executive Director
American Academy of Orthotists and Prosthetists
1650 King St., Suite 500
Alexandria, VA 22314
(703) 836-7118 fax (703) 836-0838
www.oandp.org
Orthotists and Prosthetists:
CALL TO MEMBERSHIP
FOR INFORMATION & ACTION
ISSUE: Cranial Molding Helmets
BACKGROUND: As you may know, the Food and Drug Administration has classified
the D.O.C. Band (manufactured by Cranial Technologies, Phoenix, AZ) as a
Class II medical device. Additionally, the regulation applies this control
to all cranial orthoses used in the treatment of infants 3 to 18 months of
age with non-synostotic positional plagiocephaly. The implication is that
orthotists who currently design, fit, and fabricate these orthoses in their
practices must either do so under violation of federal law, stop providing
the orthoses, or complete the 510(k) process to become registered with the
FDA to provide these orthoses.
PROBLEM: Filing a 510(k) application - a lengthy and expensive process -
would require the tracking of certain processes and the application of
control mechanisms that an orthotist, not being involved in traditional
manufacturing processes, would be unable to provide without substantially
changing his or her business. This would cause a financial hardship that
would force many to abandon this segment of their practices. Thus, large
segments of the population, such as the infant on state welfare or the
low-income infant (markets not traditionally serviced by Cranial
Technologies) would be without care.
POSITION: It is the Academy's view that orthotists have been safely and
effectively designing, custom fabricating and fitting cranial molding
helmets to their prescribing physician's specifications for nearly 20 years.
These helmets are substantially equivalent to the devices described by
Clarren in 1979 and first provided in the mid-1970's. These Clarren style
helmets differ from the patented D.O.C.Bands by virtue of their passive
design. Devices in commercial distribution prior to 1976 are exempt from
regulation. Given the very close timing of the introduction of the first
helmet by Dr. Clarren to the May 28, 1976 exemption date, and given that the
Clarren helmet and the current delivery system have a historically safe
record, the Academy believes the helmets provided by our profession should
be deemed exempt.
PLAN: To file a petition with the FDA requesting that it consider this
position.
YOUR HELP NEEDED: We need letters to attach to this petition.
From orthotists:
We need letters endorsing this position and
indicating the approximate the number of helmets fit and mentioning when you
first began providing helmets.
From your referral sources:
We need letters endorsing this position,
indicating when they began prescribing helmets and emphasizing that they
consider the helmets provided to have been safe and effective.
PLEASE PREPARE YOUR LETTERS TO:
James Dillard, Deputy Director
Division of General and Restorative Devices
FDA, 350D
9200 Corporate Boulevard
Rockville, MD 20850
Please do not send your letters directly to Mr. Dillard. Rather, send them
to the Academy where we will compile them with the others for maximum
impact.
TIMELINE: This is really quite time sensitive. We realize that the FDA's
response will take some time, however we must submit promptly. Please
forward copies of your letter(s) by APRIL 30.
ADDITIONALLY: AOPA agrees it would be very helpful to write your Senator and
Congressman explaining this issue and requesting they contact the FDA in
support of our position. To obtain your Representatives' address visit the
AOPA website at www.aopanet.org and click on Government Relations -
Legislative Action Center.
SEND A COPIES OF YOUR LETTERS TO:
Thomas A. Gorski, CAE
Executive Director
American Academy of Orthotists and
Prosthetists
1650 King Street, Suite 500
Alexandria, Virginia 22314
ACKNOWLEDGEMENTS: The Academy would like to thank the Cranial Helmet Task
Force and AOPA for their assistance in this effort.
Thomas A. Gorski, CAE
Executive Director
American Academy of Orthotists and Prosthetists
1650 King St., Suite 500
Alexandria, VA 22314
(703) 836-7118 fax (703) 836-0838
www.oandp.org
Citation
Manisha Sethi, “Announcement from the Academy,” Digital Resource Foundation for Orthotics and Prosthetics, accessed November 7, 2024, https://library.drfop.org/items/show/214176.
