80_FR_46635 80 FR 46485 - Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker

80 FR 46485 - Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 150 (August 5, 2015)

Page Range46485-46486
FR Document2015-19177

The Food and Drug Administration (FDA) is classifying the internal tissue marker 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 internal tissue marker'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.

Federal Register, Volume 80 Issue 150 (Wednesday, August 5, 2015) 
[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)]
[Rules and Regulations]
[Pages 46485-46486]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19177]



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Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 / 
Rules and Regulations

[[Page 46485]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2015-N-2457]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Internal Tissue Marker

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
internal tissue marker 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 internal tissue marker'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 August 5, 2015. The classification was 
applicable on December 18, 2014.

FOR FURTHER INFORMATION CONTACT: David Talley, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G454, Silver Spring, MD 20993-0002, 301-796-4861, 
[email protected].

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). 
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. In 
accordance with section 513(f)(1) of the FD&C Act, FDA issued an order 
on April 22, 2013, classifying the Moerae Surgical Marking Pen into 
class III, because it was not substantially equivalent to a device that 
was introduced or delivered for introduction into interstate commerce 
for commercial distribution before May 28, 1976, or a device which was 
subsequently reclassified into class I or class II.
    On May 3, 2013, VasoPrep Surgical (formerly Moerae Matrix, Inc.) 
submitted a request for classification of the VasoPrep (formerly 
Moerae) Surgical Marking Pen 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 request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1). 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, FDA determined that the device can be classified into class II 
with the establishment of special controls. FDA believes these special 
controls, in addition to general controls, will provide reasonable 
assurance of the safety and effectiveness of the device.
    Therefore, on December 18, 2014, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding Sec.  878.4670.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for an internal 
tissue marker will need to comply with the special controls named in 
this final order. The device is assigned the generic name internal 
tissue marker, and it is identified as a prescription use device that 
is intended for use prior to or during general surgical procedures to 
demarcate selected sites on internal tissues.
    FDA has identified the following risks to health associated 
specifically with

[[Page 46486]]

this type of device, as well as the mitigation measures required to 
mitigate these risks in Table 1.

      Table 1--Internal Tissue Marker Risks and Mitigation Measures
------------------------------------------------------------------------
                Identified Risks and Mitigation Measures
-------------------------------------------------------------------------
              Identified risk                    Mitigation measures
------------------------------------------------------------------------
Adverse Tissue Reaction...................  Biocompatibility Testing.
                                            Sterilization Testing.
                                            Shelf Life/Stability
                                             Testing.
                                            Performance Testing.
                                            Labeling.
Ineffective Marking.......................  Performance Testing.
                                            Shelf Life/Stability
                                             Testing.
                                            Labeling.
Improper Use..............................  Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in combination 
with the general controls, address these risks to health and provide 
reasonable assurance of safety and effectiveness:
     The device must be demonstrated to be biocompatible. 
Material names and specific designation numbers must be provided.
     Performance testing must demonstrate that the device 
performs as intended to mark the tissue for which it is indicated.
     Performance data must demonstrate the sterility of the 
device.
     Performance data must support the shelf life of the device 
by demonstrating sterility, package integrity, device functionality, 
and material stability over the requested shelf life.
     Labeling must include:
    [cir] A warning that the device must not be used on a non-sterile 
surface prior to use internally.
    [cir] An expiration date/shelf life.
    [cir] Single use only labeling must be labeled directly on the 
device.
    Internal tissue marker is a prescription device 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 internal tissue marker they intend 
to market.

II. 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 21 
CFR 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 has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and is available electronically at http://www.regulations.gov.

1. DEN130004: De Novo Request from VasoPrep Surgical (formerly 
Moerae Matrix, Inc.), dated May 3, 2013.

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.  878.4670 to subpart E to read as follows:


Sec.  878.4670  Internal tissue marker.

    (a) Identification. An internal tissue marker is a prescription use 
device that is intended for use prior to or during general surgical 
procedures to demarcate selected sites on internal tissues.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device must be demonstrated to be biocompatible. Material 
names and specific designation numbers must be provided.
    (2) Performance testing must demonstrate that the device performs 
as intended to mark the tissue for which it is indicated.
    (3) Performance data must demonstrate the sterility of the device.
    (4) Performance data must support the shelf life of the device by 
demonstrating sterility, package integrity, device functionality, and 
material stability over the requested shelf life.
    (5) Labeling must include:
    (i) A warning that the device must not be used on a non-sterile 
surface prior to use internally.
    (ii) An expiration date/shelf life.
    (iii) Single use only labeling must be labeled directly on the 
device.

    Dated: July 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19177 Filed 8-4-15; 8:45 am]
 BILLING CODE 4164-01-P

46485 Rules and Regulations Federal Register Vol. 80, No. 150 Wednesday, August 5, 2015 This section of the FEDERAL REGISTER statute into class III without any FDA classification will be the initial contains regulatory documents having general rulemaking process. These devices classification of the device. In applicability and legal effect, most of which remain in class III and require accordance with section 513(f)(1) of the are keyed to and codified in the Code of premarket approval, unless and until FD&C Act, FDA issued an order on Federal Regulations, which is published under the device is classified or reclassified April 22, 2013, classifying the Moerae 50 titles pursuant to 44 U.S.C. 1510. into class I or II, or FDA issues an order Surgical Marking Pen into class III, The Code of Federal Regulations is sold by finding the device to be substantially because it was not substantially the Superintendent of Documents. Prices of equivalent, in accordance with section equivalent to a device that was new books are listed in the first FEDERAL 513(i) of the FD&C Act, to a predicate introduced or delivered for introduction REGISTER issue of each week. device that does not require premarket into interstate commerce for commercial approval. The Agency determines distribution before May 28, 1976, or a whether new devices are substantially device which was subsequently DEPARTMENT OF HEALTH AND equivalent to predicate devices by reclassified into class I or class II. HUMAN SERVICES means of premarket notification On May 3, 2013, VasoPrep Surgical procedures in section 510(k) of the (formerly Moerae Matrix, Inc.) Food and Drug Administration FD&C Act (21 U.S.C. 360(k)) and part submitted a request for classification of 807 (21 CFR part 807) of the regulations. the VasoPrep (formerly Moerae) Surgical 21 CFR Part 878 Section 513(f)(2) of the FD&C Act, as Marking Pen under section 513(f)(2) of [Docket No. FDA–2015–N–2457] amended by section 607 of the Food and the FD&C Act. The manufacturer Drug Administration Safety and recommended that the device be Medical Devices; General and Plastic Innovation Act (Pub. L. 112–144), classified into class II (Ref. 1). Surgery Devices; Classification of the provides two procedures by which a In accordance with section 513(f)(2) of Internal Tissue Marker person may request FDA to classify a the FD&C Act, FDA reviewed the device under the criteria set forth in request in order to classify the device AGENCY: Food and Drug Administration, section 513(a)(1). Under the first under the criteria for classification set HHS. procedure, the person submits a forth in section 513(a)(1). FDA classifies ACTION: Final order. premarket notification under section devices into class II if general controls 510(k) of the FD&C Act for a device that by themselves are insufficient to SUMMARY: The Food and Drug has not previously been classified and, provide reasonable assurance of safety Administration (FDA) is classifying the within 30 days of receiving an order and effectiveness, but there is sufficient internal tissue marker into class II classifying the device into class III information to establish special controls (special controls). The special controls under section 513(f)(1) of the FD&C Act, to provide reasonable assurance of the that will apply to the device are the person requests a classification safety and effectiveness of the device for identified in this order and will be part under section 513(f)(2). Under the its intended use. After review of the of the codified language for the internal second procedure, rather than first information submitted in the request, tissue marker’s classification. The submitting a premarket notification FDA determined that the device can be Agency is classifying the device into under section 510(k) of the FD&C Act classified into class II with the class II (special controls) in order to and then a request for classification establishment of special controls. FDA provide a reasonable assurance of safety under the first procedure, the person believes these special controls, in and effectiveness of the device. determines that there is no legally addition to general controls, will DATES: This order is effective August 5, marketed device upon which to base a provide reasonable assurance of the 2015. The classification was applicable determination of substantial safety and effectiveness of the device. on December 18, 2014. equivalence and requests a classification Therefore, on December 18, 2014, FOR FURTHER INFORMATION CONTACT: under section 513(f)(2) of the FD&C Act. FDA issued an order to the requestor David Talley, Center for Devices and If the person submits a request to classifying the device into class II. FDA Radiological Health, Food and Drug classify the device under this second is codifying the classification of the Administration, 10903 New Hampshire procedure, FDA may decline to device by adding § 878.4670. Ave., Bldg. 66, Rm. G454, Silver Spring, undertake the classification request if Following the effective date of this MD 20993–0002, 301–796–4861, FDA identifies a legally marketed device final classification order, any firm david.talley@fda.hhs.gov. that could provide a reasonable basis for submitting a premarket notification SUPPLEMENTARY INFORMATION: review of substantial equivalence with (510(k)) for an internal tissue marker the device or if FDA determines that the will need to comply with the special I. Background device submitted is not of ‘‘low- controls named in this final order. The In accordance with section 513(f)(1) of moderate risk’’ or that general controls device is assigned the generic name the Federal Food, Drug, and Cosmetic would be inadequate to control the risks internal tissue marker, and it is Act (the FD&C Act) (21 U.S.C. and special controls to mitigate the risks identified as a prescription use device Lhorne on DSK7TPTVN1PROD with RULES 360c(f)(1)), devices that were not in cannot be developed. that is intended for use prior to or commercial distribution before May 28, In response to a request to classify a during general surgical procedures to 1976 (the date of enactment of the device under either procedure provided demarcate selected sites on internal Medical Device Amendments of 1976), by section 513(f)(2) of the FD&C Act, tissues. generally referred to as postamendments FDA will classify the device by written FDA has identified the following risks devices, are classified automatically by order within 120 days. This to health associated specifically with VerDate Sep<11>2014 14:23 Aug 04, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 E:\FR\FM\05AUR1.SGM 05AUR1

46486 Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 / Rules and Regulations this type of device, as well as the type is not exempt from premarket § 878.4670 Internal tissue marker. mitigation measures required to mitigate notification requirements. Persons who (a) Identification. An internal tissue these risks in Table 1. intend to market this type of device marker is a prescription use device that must submit to FDA a premarket is intended for use prior to or during TABLE 1—INTERNAL TISSUE MARKER notification, prior to marketing the general surgical procedures to RISKS AND MITIGATION MEASURES device, which contains information demarcate selected sites on internal about the internal tissue marker they tissues. Identified Risks and Mitigation Measures intend to market. (b) Classification. Class II (special II. Environmental Impact controls). The special controls for this Identified risk Mitigation measures device are: The Agency has determined under 21 (1) The device must be demonstrated Adverse Tissue Reac- Biocompatibility Test- CFR 25.34(b) that this action is of a type tion. ing. to be biocompatible. Material names and Sterilization Testing. that does not individually or specific designation numbers must be Shelf Life/Stability cumulatively have a significant effect on provided. Testing. the human environment. Therefore, (2) Performance testing must Performance Testing. neither an environmental assessment demonstrate that the device performs as Labeling. nor an environmental impact statement intended to mark the tissue for which it Ineffective Marking .... Performance Testing. is required. is indicated. Shelf Life/Stability Testing. III. Paperwork Reduction Act of 1995 (3) Performance data must Labeling. This final order establishes special demonstrate the sterility of the device. Improper Use ............ Labeling. controls that refer to previously (4) Performance data must support the approved collections of information shelf life of the device by demonstrating FDA believes that the following found in other FDA regulations. These sterility, package integrity, device special controls, in combination with collections of information are subject to functionality, and material stability over the general controls, address these risks review by the Office of Management and the requested shelf life. to health and provide reasonable Budget (OMB) under the Paperwork (5) Labeling must include: assurance of safety and effectiveness: Reduction Act of 1995 (44 U.S.C. 3501– (i) A warning that the device must not • The device must be demonstrated to 3520). The collections of information in be used on a non-sterile surface prior to be biocompatible. Material names and 21 CFR part 807, subpart E, regarding use internally. specific designation numbers must be premarket notification submissions have (ii) An expiration date/shelf life. provided. (iii) Single use only labeling must be been approved under OMB control • Performance testing must number 0910–0120, and the collections labeled directly on the device. demonstrate that the device performs as of information in 21 CFR part 801, Dated: July 30, 2015. intended to mark the tissue for which it regarding labeling have been approved Leslie Kux, is indicated. under OMB control number 0910–0485. Associate Commissioner for Policy. • Performance data must demonstrate [FR Doc. 2015–19177 Filed 8–4–15; 8:45 am] the sterility of the device. IV. Reference • Performance data must support the BILLING CODE 4164–01–P The following reference has been shelf life of the device by demonstrating placed on display in the Division of sterility, package integrity, device Dockets Management (HFA–305), Food functionality, and material stability over DEPARTMENT OF HOUSING AND and Drug Administration, 5630 Fishers the requested shelf life. URBAN DEVELOPMENT Lane, Rm. 1061, Rockville, MD 20852, • Labeling must include: and may be seen by interested persons 24 CFR Part 5 Æ A warning that the device must not between 9 a.m. and 4 p.m., Monday be used on a non-sterile surface prior to through Friday, and is available [Docket No. FR–5173–C–06] use internally. electronically at http:// RIN 2501–AD33 Æ An expiration date/shelf life. www.regulations.gov. Æ Single use only labeling must be 1. DEN130004: De Novo Request from VasoPrep Affirmatively Furthering Fair Housing; labeled directly on the device. Surgical (formerly Moerae Matrix, Inc.), Technical Correction Internal tissue marker is a dated May 3, 2013. prescription device restricted to patient AGENCY: Office of the General Counsel, use only upon the authorization of a List of Subjects in 21 CFR Part 878 HUD. practitioner licensed by law to Medical devices. ACTION: Final rule, technical correction. administer or use the device; see 21 CFR Therefore, under the Federal Food, 801.109 (Prescription devices). Drug, and Cosmetic Act and under SUMMARY: This document corrects a Section 510(m) of the FD&C Act authority delegated to the Commissioner typographical error in HUD’s final rule provides that FDA may exempt a class of Food and Drugs, 21 CFR part 878 is on Affirmatively Furthering Fair II device from the premarket notification amended as follows: Housing, published on July 16, 2015. requirements under section 510(k) of the DATES: Effective: August 17, 2015. FD&C Act, if FDA determines that PART 878—GENERAL AND PLASTIC FOR FURTHER INFORMATION CONTACT: For premarket notification is not necessary SURGERY DEVICES further information about this technical to provide reasonable assurance of the correction, contact Camille E. Acevedo, Lhorne on DSK7TPTVN1PROD with RULES safety and effectiveness of the device. ■ 1. The authority citation for 21 CFR Associate General Counsel for For this type of device, FDA has part 878 continues to read as follows: Legislation and Regulations, Office of determined that premarket notification Authority: 21 U.S.C. 351, 360, 360c, 360e, General Counsel, Department of is necessary to provide reasonable 360j, 360l, 371. Housing and Urban Development, 451 assurance of the safety and effectiveness ■ 2. Add § 878.4670 to subpart E to read 7th Street SW., Room 10282, of the device. Therefore, this device as follows: Washington, DC 20410–0500; telephone VerDate Sep<11>2014 14:23 Aug 04, 2015 Jkt 235001 PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 E:\FR\FM\05AUR1.SGM 05AUR1


Document Created: 2018-02-23 10:53:35
Document Modified: 2018-02-23 10:53:35
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal order.
DatesThis order is effective August 5, 2015. The classification was applicable on December 18, 2014.
ContactDavid Talley, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G454, Silver Spring, MD 20993-0002, 301-796-4861, [email protected]
FR Citation80 FR 46485 
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