81 FR 7452 - Medical Devices; General and Plastic Surgery Devices; Classification of the Scalp Cooling System To Reduce the Likelihood of Chemotherapy-Induced Alopecia
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 29 (February 12, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 29 (February 12, 2016)
| Page Range | 7452-7454 | |
| FR Document | 2016-02878 |
[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)] [Rules and Regulations] [Pages 7452-7454] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02878] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 DigniCapTM 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
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§ 870.4100 Extracorporeal circuit and and accessories in the circuit, and into class I or II, or FDA issues an order
accessories for long-term respiratory/ maintenance during a procedure. finding the device to be substantially
cardiopulmonary failure. equivalent, in accordance with section
Dated: February 8, 2016.
(a) Identification. An extracorporeal 513(i) of the FD&C Act, to a predicate
circuit and accessories for long-term Leslie Kux,
device that does not require premarket
respiratory/cardiopulmonary support Associate Commissioner for Policy.
approval. The Agency determines
(>6 hours) is a system of devices and [FR Doc. 2016–02876 Filed 2–11–16; 8:45 am] whether new devices are substantially
accessories that provides assisted BILLING CODE 4164–01–P equivalent to predicate devices by
extracorporeal circulation and means of premarket notification
physiologic gas exchange of the procedures in section 510(k) of the
patient’s blood in patients with acute DEPARTMENT OF HEALTH AND FD&C Act (21 U.S.C. 360(k)) and part
respiratory failure or acute HUMAN SERVICES 807 (21 CFR part 807) of the regulations.
cardiopulmonary failure, where other Section 513(f)(2) of the FD&C Act, as
available treatment options have failed, Food and Drug Administration
amended by section 607 of the Food and
and continued clinical deterioration is Drug Administration Safety and
expected or the risk of death is 21 CFR Part 878 Innovation Act (Pub. L. 112–144),
imminent. The main devices and [Docket No. FDA–2016–N–0237] provides two procedures by which a
accessories of the system include, but person may request FDA to classify a
are not limited to, the console Medical Devices; General and Plastic device under the criteria set forth in
(hardware), software, and disposables, Surgery Devices; Classification of the section 513(a)(1) of the FD&C Act.
including, but not limited to, an Scalp Cooling System To Reduce the Under the first procedure, the person
oxygenator, blood pump, heat Likelihood of Chemotherapy-Induced submits a premarket notification under
exchanger, cannulae, tubing, filters, and Alopecia section 510(k) of the FD&C Act for a
other accessories (e.g., monitors, AGENCY: Food and Drug Administration, device that has not previously been
detectors, sensors, connectors). HHS. classified and, within 30 days of
(b) Classification—Class II (special receiving an order classifying the device
controls). The special controls for this ACTION: Final order. into class III under section 513(f)(1) of
device are: SUMMARY: The Food and Drug the FD&C Act, the person requests a
(1) The technological characteristics Administration (FDA) is classifying the classification under section 513(f)(2).
of the device must ensure that the scalp cooling system to reduce the Under the second procedure, rather than
geometry and design parameters are likelihood of chemotherapy-induced first submitting a premarket notification
consistent with the intended use, and alopecia into class II (special controls). under section 510(k) of the FD&C Act
that the devices and accessories in the The special controls that will apply to and then a request for classification
circuit are compatible; the device are identified in this order under the first procedure, the person
(2) The devices and accessories in the and will be part of the codified language determines that there is no legally
circuit must be demonstrated to be for the scalp cooling system to reduce marketed device upon which to base a
biocompatible; the likelihood of chemotherapy-induced determination of substantial
(3) Sterility and shelf-life testing must equivalence and requests a classification
alopecia’s classification. The Agency is
demonstrate the sterility of any patient- under section 513(f)(2) of the FD&C Act.
classifying the device into class II
contacting devices and accessories in If the person submits a request to
(special controls) in order to provide a
the circuit and the shelf life of these classify the device under this second
reasonable assurance of safety and
devices and accessories; procedure, FDA may decline to
(4) Non-clinical performance effectiveness of the device.
undertake the classification request if
evaluation of the devices and DATES: This order is effective February
FDA identifies a legally marketed device
accessories in the circuit must 12, 2016. The classification was that could provide a reasonable basis for
demonstrate substantial equivalence of applicable on December 8, 2015. review of substantial equivalence with
the performance characteristics on the FOR FURTHER INFORMATION CONTACT: Neil the device or if FDA determines that the
bench, mechanical integrity, Ogden, Center for Devices and device submitted is not of ‘‘low-
electromagnetic compatibility (where Radiological Health, Food and Drug moderate risk’’ or that general controls
applicable), software, durability, and Administration, 10903 New Hampshire would be inadequate to control the risks
reliability; Ave., Bldg. 66, Rm. G414, Silver Spring, and special controls to mitigate the risks
(5) In vivo evaluation of the devices MD 20993–0002, 301–796–6397. cannot be developed.
and accessories in the circuit must SUPPLEMENTARY INFORMATION: In response to a request to classify a
demonstrate their performance over the device under either procedure provided
intended duration of use, including a I. Background
by section 513(f)(2) of the FD&C Act,
detailed summary of the clinical In accordance with section 513(f)(1) of FDA will classify the device by written
evaluation pertinent to the use of the the Federal Food, Drug, and Cosmetic order within 120 days. This
devices and accessories to demonstrate Act (the FD&C Act) (21 U.S.C. classification will be the initial
their effectiveness if a specific 360c(f)(1)), devices that were not in classification of the device.
indication (patient population and/or commercial distribution before May 28, On March 6, 2015, Target Health, Inc.
condition) is identified; and 1976 (the date of enactment of the (on behalf of Dignitana AB) submitted a
(6) Labeling must include a detailed Medical Device Amendments of 1976), request for classification of the
srobinson on DSK5SPTVN1PROD with RULES
summary of the non-clinical and in vivo generally referred to as postamendments DigniCapTM Scalp Cooling System
evaluations pertinent to use of the devices, are classified automatically by under section 513(f)(2) of the FD&C Act.
devices and accessories in the circuit statute into class III without any FDA The manufacturer recommended that
and adequate instructions with respect rulemaking process. These devices the device be classified into class II (Ref.
to anticoagulation, circuit setup, remain in class III and require 1).
performance characteristics with respect premarket approval, unless and until In accordance with section 513(f)(2) of
to compatibility among different devices the device is classified or reclassified the FD&C Act, FDA reviewed the
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![7454 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations
the frequency and severity of alopecia Dated: February 8, 2016. Dated: February 9, 2016.
during chemotherapy in which Leslie Kux, David S. Newman,
alopecia-inducing chemotherapeutic Associate Commissioner for Policy. Director of Legal Affairs, Visa Services,
agents are used. [FR Doc. 2016–02878 Filed 2–11–16; 8:45 am] Bureau of Consular Affairs, U.S. Department
(b) Classification—Class II (special of State.
BILLING CODE 4164–01–P
controls). The special controls for this [FR Doc. 2016–02962 Filed 2–11–16; 8:45 am]
device are: BILLING CODE 4710–06–P
(1) Non-clinical performance testing DEPARTMENT OF STATE
must demonstrate that the device meets
all design specifications and 22 CFR Part 41 PENSION BENEFIT GUARANTY
performance requirements, and that the [Public Notice: 9439] CORPORATION
device performs as intended under
anticipated conditions of use. This RIN 1400–AD17 29 CFR Part 4022
information must include testing to
Visas: Documentation of Benefits Payable in Terminated Single-
demonstrate accuracy of the
Nonimmigrants Under the Immigration Employer Plans; Interest Assumptions
temperature control mechanism.
and Nationality Act, as Amended for Paying Benefits
(2) Performance testing must
demonstrate the electromagnetic AGENCY: Department of State. AGENCY: Pension Benefit Guaranty
compatibility and electrical safety of the ACTION: Interim final rule; correction. Corporation.
device. ACTION: Final rule.
SUMMARY: The Department of State
(3) Software verification, validation,
published a Federal Register interim SUMMARY: This final rule amends the
and hazard analysis must be performed.
final rule on February 4, 2016, in Pension Benefit Guaranty Corporation’s
(4) The patient contacting Volume 81, No. 23, page 5906. The
components of the device must be regulation on Benefits Payable in
document contains an error in the Terminated Single-Employer Plans to
demonstrated to be biocompatible. Regulatory Findings. This document
Material names must be provided. prescribe interest assumptions under
corrects the rule by replacing the text, the regulation for valuation dates in
(5) Labeling must include the ‘‘included elsewhere in this edition of
following: March 2016. The interest assumptions
the Federal Register’’ with ‘‘published are used for paying benefits under
(i) A statement describing the in the Federal Register on February 8, terminating single-employer plans
potential risk of developing scalp 2016, 81 FR 6430.’’ There is also a covered by the pension insurance
metastasis. correction in the ADDRESSES section, to system administered by PBGC.
(ii) Information on the patient provide the correct public notice
number to find the rule to submit DATES: Effective March 1, 2016.
population and chemotherapeutic
agents/regimen for which the device has comments on www.regulations.gov. FOR FURTHER INFORMATION CONTACT:
been demonstrated to be effective. DATES: This correction is effective on Catherine B. Klion (Klion.Catherine@
February 19, 2016. Written comments pbgc.gov), Assistant General Counsel for
(iii) A summary of the non-clinical
must be received on or before April 4, Regulatory Affairs, Pension Benefit
and/or clinical testing pertinent to use
2016. Guaranty Corporation, 1200 K Street
of the device.
FOR FURTHER INFORMATION CONTACT:
NW., Washington, DC 20005, 202–326–
(iv) A summary of the device 4024. (TTY/TDD users may call the
technical parameters, including Paul-Anthony L. Magadia, U.S.
Department of State, Visa Services, Federal relay service toll-free at 1–800–
temperature cooling range and duration 877–8339 and ask to be connected to
of cooling. Legislation and Regulations Division,
Washington, DC 20006, 202–485–7641; 202–326–4024.)
(v) A summary of the device- and SUPPLEMENTARY INFORMATION: PBGC’s
email: magadiapl@state.gov.
procedure-related adverse events regulation on Benefits Payable in
pertinent to use of the device. SUPPLEMENTARY INFORMATION: The
Department of State published an Terminated Single-Employer Plans (29
(vi) Information on how the device CFR part 4022) prescribes actuarial
interim final rule on February 4, 2016
operates and the typical course of assumptions—including interest
(81 FR 5906); this document corrects
treatment. assumptions—for paying plan benefits
text in the ADDRESSES section and in the
(6) Patient labeling must be provided discussion of Executive Order 12866. under terminating single-employer
and must include: plans covered by title IV of the
(i) Relevant contraindications, Correction Employee Retirement Income Security
warnings, precautions, and adverse In the FR Doc 2016–02191, appearing Act of 1974. The interest assumptions in
effects/complications. on page 5906 in the Federal Register of the regulation are also published on
(ii) Information on how the device February 4, 2016 (81 FR 5906): PBGC’s Web site (http://www.pbgc.gov).
operates and the typical course of 1. In the second column of page 5906, PBGC uses the interest assumptions in
treatment. third item under ADDRESSES, the term Appendix B to Part 4022 to determine
‘‘XXXX’’ is corrected to read ‘‘9428.’’ whether a benefit is payable as a lump
(iii) Information on the patient
2. In the third column of page 5907, sum and to determine the amount to
population for which there is clinical
the first sentence of the discussion pay. Appendix C to Part 4022 contains
evidence of effectiveness.
srobinson on DSK5SPTVN1PROD with RULES
regarding ‘‘Executive Order 12866: interest assumptions for private-sector
(iv) The potential risks and benefits Regulatory Review’’ is corrected to read: pension practitioners to refer to if they
associated with use of the device. ‘‘The costs of this rulemaking are wish to use lump-sum interest rates
(v) Postoperative care instructions. discussed in the companion DHS rule, determined using PBGC’s historical
(vi) A statement describing the RIN 1651–AB09, published in the methodology. Currently, the rates in
potential risk of developing scalp Federal Register on February 8, 2016, Appendices B and C of the benefit
metastasis. 81 FR 6430.’’ payment regulation are the same.
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Document Created: 2016-02-12 01:24:10
Document Modified: 2016-02-12 01:24:10
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective February 12, 2016. The classification was applicable on December 8, 2015. | |
| 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. | |
| FR Citation | 81 FR 7452 |
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