Re: cranial helmet postings -- Long Message
Bob Van Hook
Description
Collection
Title:
Re: cranial helmet postings -- Long Message
Creator:
Bob Van Hook
Date:
1/20/2000
Text:
John, et. al.,
I am appending the text of a special report that AOPA sent to its members
recently regarding cranial orthoses. AOPA is not happy with the results of
our research, but we will continue to advise our members on this issue. You
may direct any questions or comments to me or to Kathy Dodson,
<Email Address Redacted>
Bob
Robert T. Van Hook, CAE
Executive Director
American Orthotic and Prosthetic Association
1650 King Street, Suite 500
Alexandria, VA 22314
Phone: 703/836-7116
Fax: 703/836-0838
STMP: <Email Address Redacted>
URL: <URL Redacted>
FDA Regulations Regarding Cranial Orthoses
A question has recently arisen in the field concerning FDA requirements
regarding the production of cranial orthoses for our patients. AOPA has
researched this issue and offers the following information.
We strongly recommend that if your facility produces the types of devices
discussed below, you review the following to assist in determining future
patient care and billing procedures. We will provide you with additional
information as it is received.
Background
Based upon the Federal Food, Drug & Cosmetic Act (FDCA), as amended by
the Safe Medical Devices Act (SMDA), any manufacturer who produces medical
devices is subject to FDA regulation. The extent of regulation is dependent
upon the classification under which the device falls.
There are three classes of medical devices:
* Class I devices are the least regulated, requiring that manufacturers
register with the FDA, list their devices, and follow Good Manufacturing
Practices (GMP). Almost all O&P products have been determined to be Class I
devices. Although many Class I device also must go through FDA's premarket
notification process under section 510(k) of the FDCA, most have been
exempted from 510(k) requirements. Such exemptions apply to: prosthetic and
orthotic accessories, external limb orthotic components, external limb
prosthetic components, limb orthoses, truncal orthoses, congenital hip
dislocation abduction splints, and Dennis Brown splints. (Cranial orthoses
are not listed as exempt.)
* Class II devices are subject to all of the Class I requirements, plus
special controls determined individually for each device. Cranial orthoses
used for plagiocephaly are Class II devices and are not exempt from the
requirement to file a 510(k) notice. Cranial orthoses used as protective
helmets are not yet classified. Although FDA may classify protective helmets
as Class I devices, FDA has not yet done so and has not exempted these
devices from 510(k) requirements.
* Class III devices have the highest regulation, and must go through
Premarket Approval (PMA) prior to being sold. This classification is most
commonly used for implantable medical devices, among others.
FDA generally regards O&P providers as service providers rather than
manufacturers, based on the agency's understanding that O&P providers
mainly assemble and fit components that are manufactured by others. Thus,
FDA has not expected O&P providers to comply with labeling, manufacturing,
and premarket notice requirements that were applicable to the manufacturer
of the component.
Although FDA generally regards O&P providers as service providers, FDA
may try to regulate O&P providers as manufacturers where the FDA decides
that the actions of the provider really qualify as manufacturing. In any
such case, the provider would be expected to comply with FDA requirements
for manufacturers.
FDA Approved Orthoses
Currently, the only cranial orthosis that has received FDA approval
through the 510(k) notification (approval) process is the DOC( Band,
manufactured by Cranial Technologies, Inc. The product is classified as
Class II and the notice of this classification was published in the July 30,
1998 Federal Register (this can be found on the Federal Register Web site at
www.access.gpo.gov/su_docs/aces/aces140.html). In this notice, the FDA
describes cranial orthoses by the patient age group and diagnosis, as
cranial orthoses for the treatment of positional plagiocephaly in 3 to 18
month old infants. This notice strongly suggests that any cranial orthosis
for positional plagiocephaly will be considered Class II.
Cranial orthoses used for purposes other than improving the symmetry of
the infant's head have not been classified. However, while they do not
appear to come under the specific FDA notice dealing with orthoses for
plagiocephaly, manufacturers of protective helmets who first marketed their
product after 1976 will probably still have to register and file a 510(k)
notice.
Current Situation
Because Cranial Technologies, Inc. has filed a 510(k) notice that has
been cleared by FDA for cranial orthoses for plagiocephaly, O&P facilities
that provide such devices acquired through this company will not be required
to comply with any FDA regulations for manufacturers. However, if O&P
facilities choose to fabricate such devices themselves, FDA will probably
expect them to register as a manufacturer with the FDA, file a 510(k) notice
and comply with appropriate FDA statutory and regulatory requirements.
Failure to comply with these requirements could be deemed a violation of the
FDCA and could result in an FDA enforcement action. In addition, if
providers were to become involved in malpractice suits, failure to comply
with these requirements may increase the likelihood of liability.
Therefore, those O&P facilities that fabricate their own cranial orthoses
for the treatment of plagiocephaly should seriously consider registering
with FDA, filing a 510(k) notice, and complying with other legal
requirements for device manufacturers. Likewise, companies that fabricate
protective helmets should also seriously consider registering with FDA,
filing a 510(k) notice, and complying with other legal requirements for
device manufacturers. Information on FDA requirements for manufacturers,
including how to register and file a 510(k) notice, can be found on the FDA
Web site at www.fda.gov/cdrh/devadvice/.
Further Action
AOPA is contacting the FDA to obtain further clarification of this
situation, including the reclassification and potential exemption from
510(k) of the protective cranial helmet, and what criteria the agency uses
to determine when a provider becomes a manufacturer. We will notify you of
the response as soon as it is received. Until then, each company should
assess their own situation and determine the impact this information may
have on their operations.
I am appending the text of a special report that AOPA sent to its members
recently regarding cranial orthoses. AOPA is not happy with the results of
our research, but we will continue to advise our members on this issue. You
may direct any questions or comments to me or to Kathy Dodson,
<Email Address Redacted>
Bob
Robert T. Van Hook, CAE
Executive Director
American Orthotic and Prosthetic Association
1650 King Street, Suite 500
Alexandria, VA 22314
Phone: 703/836-7116
Fax: 703/836-0838
STMP: <Email Address Redacted>
URL: <URL Redacted>
FDA Regulations Regarding Cranial Orthoses
A question has recently arisen in the field concerning FDA requirements
regarding the production of cranial orthoses for our patients. AOPA has
researched this issue and offers the following information.
We strongly recommend that if your facility produces the types of devices
discussed below, you review the following to assist in determining future
patient care and billing procedures. We will provide you with additional
information as it is received.
Background
Based upon the Federal Food, Drug & Cosmetic Act (FDCA), as amended by
the Safe Medical Devices Act (SMDA), any manufacturer who produces medical
devices is subject to FDA regulation. The extent of regulation is dependent
upon the classification under which the device falls.
There are three classes of medical devices:
* Class I devices are the least regulated, requiring that manufacturers
register with the FDA, list their devices, and follow Good Manufacturing
Practices (GMP). Almost all O&P products have been determined to be Class I
devices. Although many Class I device also must go through FDA's premarket
notification process under section 510(k) of the FDCA, most have been
exempted from 510(k) requirements. Such exemptions apply to: prosthetic and
orthotic accessories, external limb orthotic components, external limb
prosthetic components, limb orthoses, truncal orthoses, congenital hip
dislocation abduction splints, and Dennis Brown splints. (Cranial orthoses
are not listed as exempt.)
* Class II devices are subject to all of the Class I requirements, plus
special controls determined individually for each device. Cranial orthoses
used for plagiocephaly are Class II devices and are not exempt from the
requirement to file a 510(k) notice. Cranial orthoses used as protective
helmets are not yet classified. Although FDA may classify protective helmets
as Class I devices, FDA has not yet done so and has not exempted these
devices from 510(k) requirements.
* Class III devices have the highest regulation, and must go through
Premarket Approval (PMA) prior to being sold. This classification is most
commonly used for implantable medical devices, among others.
FDA generally regards O&P providers as service providers rather than
manufacturers, based on the agency's understanding that O&P providers
mainly assemble and fit components that are manufactured by others. Thus,
FDA has not expected O&P providers to comply with labeling, manufacturing,
and premarket notice requirements that were applicable to the manufacturer
of the component.
Although FDA generally regards O&P providers as service providers, FDA
may try to regulate O&P providers as manufacturers where the FDA decides
that the actions of the provider really qualify as manufacturing. In any
such case, the provider would be expected to comply with FDA requirements
for manufacturers.
FDA Approved Orthoses
Currently, the only cranial orthosis that has received FDA approval
through the 510(k) notification (approval) process is the DOC( Band,
manufactured by Cranial Technologies, Inc. The product is classified as
Class II and the notice of this classification was published in the July 30,
1998 Federal Register (this can be found on the Federal Register Web site at
www.access.gpo.gov/su_docs/aces/aces140.html). In this notice, the FDA
describes cranial orthoses by the patient age group and diagnosis, as
cranial orthoses for the treatment of positional plagiocephaly in 3 to 18
month old infants. This notice strongly suggests that any cranial orthosis
for positional plagiocephaly will be considered Class II.
Cranial orthoses used for purposes other than improving the symmetry of
the infant's head have not been classified. However, while they do not
appear to come under the specific FDA notice dealing with orthoses for
plagiocephaly, manufacturers of protective helmets who first marketed their
product after 1976 will probably still have to register and file a 510(k)
notice.
Current Situation
Because Cranial Technologies, Inc. has filed a 510(k) notice that has
been cleared by FDA for cranial orthoses for plagiocephaly, O&P facilities
that provide such devices acquired through this company will not be required
to comply with any FDA regulations for manufacturers. However, if O&P
facilities choose to fabricate such devices themselves, FDA will probably
expect them to register as a manufacturer with the FDA, file a 510(k) notice
and comply with appropriate FDA statutory and regulatory requirements.
Failure to comply with these requirements could be deemed a violation of the
FDCA and could result in an FDA enforcement action. In addition, if
providers were to become involved in malpractice suits, failure to comply
with these requirements may increase the likelihood of liability.
Therefore, those O&P facilities that fabricate their own cranial orthoses
for the treatment of plagiocephaly should seriously consider registering
with FDA, filing a 510(k) notice, and complying with other legal
requirements for device manufacturers. Likewise, companies that fabricate
protective helmets should also seriously consider registering with FDA,
filing a 510(k) notice, and complying with other legal requirements for
device manufacturers. Information on FDA requirements for manufacturers,
including how to register and file a 510(k) notice, can be found on the FDA
Web site at www.fda.gov/cdrh/devadvice/.
Further Action
AOPA is contacting the FDA to obtain further clarification of this
situation, including the reclassification and potential exemption from
510(k) of the protective cranial helmet, and what criteria the agency uses
to determine when a provider becomes a manufacturer. We will notify you of
the response as soon as it is received. Until then, each company should
assess their own situation and determine the impact this information may
have on their operations.
Citation
Bob Van Hook, “Re: cranial helmet postings -- Long Message,” Digital Resource Foundation for Orthotics and Prosthetics, accessed November 2, 2024, https://library.drfop.org/items/show/213398.
