[Federal Register Volume 71, Number 247 (Tuesday, December 26, 2006)]
[Notices]
[Pages 77400-77402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-22072]


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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-

[[Page 77401]]

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