[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Rules and Regulations]
[Pages 7452-7454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02878]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2016-N-0237]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Scalp Cooling System To Reduce the Likelihood of 
Chemotherapy-Induced Alopecia

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
scalp cooling system to reduce the likelihood of chemotherapy-induced 
alopecia into class II (special controls). The special controls that 
will apply to the device are identified in this order and will be part 
of the codified language for the scalp cooling system to reduce the 
likelihood of chemotherapy-induced alopecia's classification. The 
Agency is classifying the device into class II (special controls) in 
order to provide a reasonable assurance of safety and effectiveness of 
the device.

DATES: This order is effective February 12, 2016. The classification 
was applicable on December 8, 2015.

FOR FURTHER INFORMATION CONTACT: Neil Ogden, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G414, Silver Spring, MD 20993-0002, 301-796-6397.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1) of 
the FD&C Act. Under the first procedure, the person submits a premarket 
notification under section 510(k) of the FD&C Act for a device that has 
not previously been classified and, within 30 days of receiving an 
order classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person requests a classification under section 
513(f)(2). Under the second procedure, rather than first submitting a 
premarket notification under section 510(k) of the FD&C Act and then a 
request for classification under the first procedure, the person 
determines that there is no legally marketed device upon which to base 
a determination of substantial equivalence and requests a 
classification under section 513(f)(2) of the FD&C Act. If the person 
submits a request to classify the device under this second procedure, 
FDA may decline to undertake the classification request if FDA 
identifies a legally marketed device that could provide a reasonable 
basis for review of substantial equivalence with the device or if FDA 
determines that the device submitted is not of ``low-moderate risk'' or 
that general controls would be inadequate to control the risks and 
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On March 6, 2015, Target Health, Inc. (on behalf of Dignitana AB) 
submitted a request for classification of the DigniCap<SUP>TM</SUP> 
Scalp Cooling System under section 513(f)(2) of the FD&C Act. The 
manufacturer recommended that the device be classified into class II 
(Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the

[[Page 7453]]

request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act. FDA 
classifies devices into class II 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 reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the request and the medical literature, if 
applicable, FDA determined that the device can be classified into class 
II with the establishment of special controls. FDA believes these 
special controls will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on December 8, 2015, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding Sec.  878.4360 (21 CFR 
878.4360).
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a scalp 
cooling system to reduce the likelihood of chemotherapy-induced 
alopecia will need to comply with the special controls named in this 
final order.
    The device is assigned the generic name scalp cooling system to 
reduce the likelihood of chemotherapy-induced alopecia, and it is 
identified as a scalp cooling system to reduce the likelihood of 
chemotherapy-induced alopecia intended to reduce the frequency and 
severity of alopecia during chemotherapy in which alopecia-inducing 
chemotherapeutic agents are used. The device is a prescription device.
    FDA has identified the following risks to health associated with 
this type of device and the measures required to mitigate these risks:

 Table 1--Scalp Cooling System To Reduce the Likelihood of Chemotherapy-
             Induced Alopecia Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Thermal Tissue Damage..................  Non-clinical Performance
                                          Testing.
                                         Software Verification,
                                          Validation, and Hazard
                                          Analysis Labeling.
Electromagnetic Interference/Electrical  Electromagnetic Compatibility
 Shock.                                   and Electrical Testing
                                          Labeling.
Adverse Tissue Reaction................  Biocompatibility.
Increased Risk of Scalp Metastases.....  Labeling.
                                         Patient Labeling.
Use Error..............................  Labeling.
Scalp Pain, Headache, and Chills.......  Labeling.
                                         Patient Labeling.
------------------------------------------------------------------------

    FDA believes that the special controls in Sec.  878.4360(b)(1) 
through (6), in addition to the general controls, address these risks 
to health and provide reasonable assurance of safety and effectiveness.
    Scalp cooling systems to reduce the likelihood of chemotherapy-
induced alopecia are prescription devices restricted to patient use 
only upon the authorization of a practitioner licensed by law to 
administer or use the device; see 21 CFR 801.109 (Prescription 
devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act, if FDA determines that premarket notification 
is not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type is not exempt from premarket notification 
requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification, prior to marketing the device, 
which contains information about the scalp cooling system to reduce the 
likelihood of chemotherapy-induced alopecia they intend to market.

II. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 
part 807, subpart E, regarding premarket notification submissions have 
been approved under OMB control number 0910-0120, and the collections 
of information in 21 CFR part 801, regarding labeling, have been 
approved under OMB control number 0910-0485.

IV. Reference

    The following reference is on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and is available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it 
is also available electronically at http://www.regulations.gov.

1. DEN150010: De novo request per 513(f)(2) from Target Health, Inc. 
(on behalf of Dignitana AB), dated March 6, 2015.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  878.4360 to subpart E to read as follows:


Sec.  878.4360  Scalp cooling system to reduce the likelihood of 
chemotherapy-induced alopecia.

    (a) Identification. A scalp cooling system to reduce the likelihood 
of chemotherapy-induced alopecia is a prescription device intended to 
reduce

[[Page 7454]]

the frequency and severity of alopecia during chemotherapy in which 
alopecia-inducing chemotherapeutic agents are used.
    (b) Classification--Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device meets all design specifications and performance requirements, 
and that the device performs as intended under anticipated conditions 
of use. This information must include testing to demonstrate accuracy 
of the temperature control mechanism.
    (2) Performance testing must demonstrate the electromagnetic 
compatibility and electrical safety of the device.
    (3) Software verification, validation, and hazard analysis must be 
performed.
    (4) The patient contacting components of the device must be 
demonstrated to be biocompatible. Material names must be provided.
    (5) Labeling must include the following:
    (i) A statement describing the potential risk of developing scalp 
metastasis.
    (ii) Information on the patient population and chemotherapeutic 
agents/regimen for which the device has been demonstrated to be 
effective.
    (iii) A summary of the non-clinical and/or clinical testing 
pertinent to use of the device.
    (iv) A summary of the device technical parameters, including 
temperature cooling range and duration of cooling.
    (v) A summary of the device- and procedure-related adverse events 
pertinent to use of the device.
    (vi) Information on how the device operates and the typical course 
of treatment.
    (6) Patient labeling must be provided and must include:
    (i) Relevant contraindications, warnings, precautions, and adverse 
effects/complications.
    (ii) Information on how the device operates and the typical course 
of treatment.
    (iii) Information on the patient population for which there is 
clinical evidence of effectiveness.
    (iv) The potential risks and benefits associated with use of the 
device.
    (v) Postoperative care instructions.
    (vi) A statement describing the potential risk of developing scalp 
metastasis.

    Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02878 Filed 2-11-16; 8:45 am]
BILLING CODE 4164-01-P