[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)]
[Rules and Regulations]
[Pages 46485-46486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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