[Federal Register: December 26, 2006 (Volume 71, Number 247)]
[Notices]
[Page 77400-77402]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26de06-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P-0085]
Medical Devices; Exemptions from Premarket Notification; Class II
Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing an order
denying a petition requesting exemption for cranial orthosis type
devices from the premarket notification requirements for certain class
II devices. A cranial orthosis device is a device intended to apply
pressure to prominent regions of an infant's cranium in order to
improve cranial symmetry or shape. FDA is publishing this notice in
accordance with procedures established by the Food and Drug
Administration Modernization Act of 1997 (FDAMA).
DATES: This order is effective December 26, 2006.
FOR FURTHER INFORMATION CONTACT: Heather Rosecrans, Center for Devices
and Radiological Health (HFZ-404), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-4040.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 513 of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of safety and effectiveness. Under the
Medical Device Amendments of 1976 (the 1976 amendments (Public Law 94-
295)), as amended by the Safe Medical Devices Act of 1990 (the SMDA)
(Public Law 101-629)), devices are to be classified into class I
(general controls) if there is information showing that the general
controls of the act are sufficient to assure safety and effectiveness;
into class II (special controls), if general controls, by themselves,
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide such assurance; and into class III (premarket
approval), if there is insufficient information to support classifying
a device into class I or class II and the device is a life-sustaining
or life-
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supporting device or is for a use which is of substantial importance in
preventing impairment of human health, or presents a potential
unreasonable risk of illness or injury.
Most generic types of devices that were on the market before the
date of the 1976 amendments (May 28, 1976) (generally referred to as
preamendments devices) have been classified by FDA under the procedures
set forth in section 513(c) and (d) of the act through the issuance of
classification regulations into one of these three regulatory classes.
Devices introduced into interstate commerce for the first time on
or after May 28, 1976 (generally referred to as postamendments devices)
are classified through the premarket notification process under section
510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the
implementing regulations, 21 CFR part 807, require persons who intend
to market a new device to submit a premarket notification report
(510(k)) containing information that allows FDA to determine whether
the new device is ``substantially equivalent'' within the meaning of
section 513(i) of the act to a legally marketed device that does not
require premarket approval.
On November 21, 1997, the President signed into law FDAMA (Public
Law 105-115). Section 206 of FDAMA, in part, added section 510(m) to
the act. Section 510(m)(l) of the act requires FDA, within 60 days
after enactment of FDAMA, to publish in the Federal Register a list of
each type of class II device that does not require a report under
section 510(k) of the act to provide reasonable assurance of safety and
effectiveness. Section 510(m) of the act further provides that a 510(k)
will no longer be required for these devices upon the date of
publication of the list in the Federal Register. FDA published that
list in the Federal Register of January 21, 1998 (63 FR 3142). Section
510(m)(2) of the act provides that, 1 day after date of publication of
the list under section 510(m)(l), FDA may exempt a device on its own
initiative or upon petition of an interested person, if FDA determines
that a 510(k) is not necessary to provide reasonable assurance of the
safety and effectiveness of the device. This section requires FDA to
publish in the Federal Register a notice of intent to exempt a device,
or of the petition, and to provide a 30-day comment period. Within 120
days of publication of this document, FDA must publish in the Federal
Register its final determination regarding the exemption of the device
that was the subject of the notice. If FDA fails to respond to a
petition under this section within 180 days of receiving it, the
petition shall be deemed granted.
FDA classified the cranial orthosis into class II (special
controls) effective August 31, 1998 (63 FR 40650, July 30, 1998). The
classification regulation for cranial orthosis is at 21 CFR 882.5970.
The cranial orthosis is identified as a device that is intended for
medical purposes to apply pressure to prominent regions of an infant's
cranium in order to improve cranial symmetry and/or shape in infants
from 3 to 18 months of age, with moderate to severe nonsynostotic
positional plagiocephaly, including infants with plagiocephalic-,
brachycephalic-, and scaphocephalic-shaped heads.
II. Criteria for Exemption
There are a number of factors FDA may consider when determining
whether a 510(k) is necessary to provide reasonable assurance of the
safety and effectiveness of a class II device, including the factors
discussed in the guidance entitled ``Procedures for Class II Device
Exemptions from Premarket Notification, Guidance for Industry and CDRH
Staff'' (available at http://www.fda.gov/cdrh/modact/exemii.pdf or by
sending a fax request to 240-276-3151 to receive a hard copy). The
factors outlined in the guidance included: (1) The device does not have
a significant history of false or misleading claims or risks associated
with inherent characteristics of the device; (2) characteristics of the
device necessary for its safe and effective performance are well
established; (3) changes in the device that could affect safety and
effectiveness will either (a) be readily detectable by users by visual
examination or other means such as routine testing, before causing
harm, e.g., testing of a clinical laboratory reagent with positive or
negative controls, or (b) not materially increase the risk of injury,
incorrect diagnosis, or ineffective treatment; and (4) any changes to
the device would not be likely to result in a change in the device's
classification. FDA also considered that, even when exempting devices,
these devices would still be subject to the limitations on exemptions.
III. Petition
FDA received a petition requesting an exemption from premarket
notification for class II devices, 21 CFR 882.5970 Cranial orthosis,
from Catherine Jeakle Hill, on behalf of the American Association of
Neurological Surgeons (AANS), the Congress of Neurological Surgeons
(CNS), and the AANS/CNS Section on Pediatrics.
On October 24, 2006 (71 FR 62268), FDA published a notice
announcing that this petition had been received and providing an
opportunity for interested persons to submit comments on the petition
by November 24, 2006.
IV. Summary of Public Comments
FDA received a total of 39 comments (42 individuals; 3 letters had
2 signatures) regarding this petition. We have summarized the comments
as follows:
A. Comments Supporting the Petition for Exemption
FDA received 13 comments supporting an exemption from premarket
notification for this type of device, including:
Four comments stated that cranial orthoses have similar risks and
technological considerations as those used for Class I exempt orthotics
for use on other parts of the body.
FDA disagrees. FDA has identified specific health risks inherent to
the cranial orthosis indications and technological characteristics (63
FR 40650). Some of the literature referenced by the petitioner also
identified the risks inherent to cranial orthoses, e.g., restriction of
cranial growth.
Eleven comments supported the petition stating that cranial
orthoses are safe, and four comments stated that long term use is
evidence of efficacy. One comment stated that the limitations to the
exemption are sufficient for monitoring changes in intended use and
technology. However, FDA believes that the petition failed to provide
information, including potential special controls, to establish that
premarket notification is not necessary to provide reasonable assurance
of safety and effectiveness and to assure that health risks associated
with inherent characteristics of the device and indications are
addressed. Additionally, the petition failed to describe how changes in
the device that could lead to device failures would either: (1) Be
readily detectable by users by visual examination or other means, such
as routine testing, before causing harm; or (2) not materially increase
the risk of injury or ineffective treatment.
In addition, the petitioner did not provide sufficient information
to address the frequency, persistence, cause, or seriousness of the
inherent risks of the device or to establish special controls to
address the health risks associated with cranial orthoses. The
petitioner did not specify whether a comprehensive search of the
medical literature and other available,
[[Page 77402]]
unpublished data was conducted to substantiate that the safety can be
assured if cranial orthoses are exempted from the requirements of
premarket notification. Some of the public comments identified
literature regarding additional safety issues that had not been
identified by the petitioner.
One comment generally supported the petition, but stated that
cranial orthoses indicated for posterior plagiocephaly should either
have fabrication restrictions removed or the device should be pulled
from the market until efficacy data is provided. FDA disagrees with
this comment. Cranial orthoses are class II devices with special
controls, including the requirement for premarket notification. This
has assured reasonable safety and effectiveness for use with infants
having posterior plagiocephaly.
Eleven comments stated that current regulation requirements inflate
cost. Additionally, four comments stated that current regulation
requirements decrease accessibility. FDA has no comment because neither
issue is a criterion for exemption of a class II device.
B. Comments Opposing the Petition for Exemption
FDA received 26 comments (29 individuals; 3 letters had 2
signatures) opposing an exemption from premarket notification for these
devices, including:
Twenty-four comments stated that exemption would fail to provide
reasonable assurance of the safety and effectiveness of these devices.
One comment states that special controls are required to ensure
reasonable safety and effectiveness.
FDA agrees that insufficient information is available in the
petition for FDA to make a determination that premarket clearance is
not necessary to provide reasonable assurance of safety and
effectiveness. FDA also agrees that special controls are required in
order to address the health risks associated with inherent
characteristics and indications of this class II device, and FDA has
established special controls for the device (63 FR 40650). In addition,
we have previously determined that premarket notification review and
clearance was necessary prior to introducing the device into commercial
distribution. As discussed previously, the petitioner did not provide
sufficient information, which might include special controls, to
address the health risks associated with cranial orthoses and that
would sufficiently address the factors FDA considers important in
determining whether to grant an exemption of a class II device.
One comment stated that there are no documented industry
fabrication standards.
FDA believes this comment refers to the lack of recognized
voluntary standards. FDA agrees and notes that it has not recognized
any consensus standards relevant to the fabrication of cranial orthoses
that would suffice as special controls, which could sufficiently
address the factors FDA considers important in determining whether to
grant an exemption of a class II device.
Nineteen comments stated that cranial orthoses should be regulated
because they are indicated for a vulnerable population. One comment
stated that the complexity of medical conditions that result in the
need for treatment with these devices is just starting to be reported
in the medical literature.
FDA believes that the level of regulation needed for this condition
in a vulnerable population is commensurate with class II, including
special controls. The petition provided insufficient information for
developing special controls that would provide reasonable assurance of
safety and effectiveness, when used on infants with complex medical
conditions, if this type of device was exempt from premarket
notification.
Four comments stated the petition has insufficient information for
addressing the factors FDA considers important in determining whether
to grant an exemption of a class II device from premarket notification,
FDA agrees, as discussed earlier.
One comment stated that exemption of cranial orthoses will allow
unqualified individuals to treat these patients and lower the standard
of care. FDA does not regulate the qualifications of healthcare
practitioners. However, regardless of whether a class II device is
exempt from premarket notification, FDA can require prescription use
labeling for class II devices. Prescription use labeling is required
for this type of device.
Five comments stated that access has not been deterred by the Class
II designation. Three comments stated that there is insufficient
evidence that innovation has been deterred by the Class II designation.
Five comments stated that price increases are due to the significant
increase in the service-intensity of this therapy. FDA has no comment
because none of these issues is a criterion for exemption of a class II
device.
V. Order
After reviewing the petition and for the reasons explained
previously, FDA has determined that the petition failed to provide
information that premarket clearance is not necessary to provide
reasonable assurance of safety and effectiveness. Therefore, FDA is
issuing this order denying the petition requesting exemption for
cranial orthosis from the premarket notification requirements.
Dated: December 19, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-22072 Filed 12-22-06; 8:45 am]
BILLING CODE 4160-01-S