81 FR 48703 - Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 143 (July 26, 2016)

Page Range		48703-48707
FR Document		2016-17609
The Food and Drug Administration (FDA) is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments class III devices (regulated under product code EGJ), into class II (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs are not considered part of this regulatory classification.
Federal Register, Volume 81 Issue 143 (Tuesday, July 26, 2016)
[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Rules and Regulations]
[Pages 48703-48707]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-17609]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2000-N-0158]


Physical Medicine Devices; Reclassification of Iontophoresis 
Device Intended for Any Other Purposes

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing a final 
order to reclassify iontophoresis devices intended for any other 
purposes, which are preamendments class III devices (regulated under 
product code EGJ), into class II (special controls) and to amend the 
device identification to clarify that devices intended to deliver 
specific drugs are not considered part of this regulatory 
classification.

DATES: This order is effective on July 26, 2016.

FOR FURTHER INFORMATION CONTACT: Jismi Johnson, Center for Devices and 
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1524, 
Silver Spring, MD 20993, 301-796-6424, jismi.johnson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended 
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the 
Food and Drug Administration Modernization Act

[[Page 48704]]

of 1997 (Pub. L. 105-115), the Medical Device User Fee and 
Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices 
Technical Corrections Act (Pub. L. 108-214), the Food and Drug 
Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food 
and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 
112-144), among other amendments, established a comprehensive system 
for the regulation of medical devices intended for human use. Section 
513 of the FD&C Act (21 U.S.C. 360c) established three categories 
(classes) of devices, reflecting the regulatory controls needed to 
provide reasonable assurance of their safety and effectiveness. The 
three categories of devices are class I (general controls), class II 
(special controls), and class III (premarket approval).
    Under section 513(d) of the FD&C Act, devices that were in 
commercial distribution before the enactment of the 1976 amendments, 
May 28, 1976 (generally referred to as preamendments devices), are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    A preamendments device that has been classified into class III and 
devices found substantially equivalent by means of premarket 
notification procedures (510(k)) to such a preamendments device or to a 
device within that type (both the preamendments and substantially 
equivalent devices are referred to as preamendments class III devices) 
may be marketed without submission of a premarket approval application 
(PMA) until FDA issues a final order under section 515(b) of the FD&C 
Act (21 U.S.C. 360e(b)) requiring premarket approval or until the 
device is subsequently reclassified into class I or class II.
    Devices that were not in commercial distribution prior to May 28, 
1976 (generally referred to as postamendments devices) are 
automatically classified by section 513(f) of the FD&C Act into class 
III without any FDA rulemaking process. Those devices remain in class 
III and require premarket approval unless, and until, the device is 
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).
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA 
amended section 513(e) of the FD&C Act, changing the mechanism for 
reclassifying a device under that section from rulemaking to an 
administrative order.
    Section 513(e) of the FD&C Act governs reclassification of 
classified devices. This section provides that FDA may, by 
administrative order, reclassify a device based on ``new information.'' 
FDA can initiate a reclassification under section 513(e) of the FD&C 
Act or an interested person may petition FDA to reclassify a 
preamendments device. The term ``new information,'' as used in section 
513(e), includes information developed as a result of a reevaluation of 
the data before the Agency when the device was originally classified, 
as well as information not presented, not available, or not developed 
at that time. (See, e.g., Holland-Rantos Co. v. United States 
Department of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 
(D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell 
v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an 
appropriate basis for subsequent action where the reevaluation is made 
in light of newly available authority (see Bell, 366 F.2d at 181; 
Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in 
light of changes in ``medical science'' (Upjohn, 422 F.2d at 951). 
Whether data before the Agency are old or new data, the ``new 
information'' to support reclassification under section 513(e) must be 
``valid scientific evidence,'' as defined in section 513(a)(3) of the 
FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. 
FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Association v. FDA, 
766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. To be 
considered in the reclassification process, the ``valid scientific 
evidence'' upon which the Agency relies must be publicly available. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).)
    Section 513(e)(1) of the FD&C Act sets forth the process for 
issuing a final order to reclassify a device under that section. 
Specifically, prior to the issuance of a final order reclassifying a 
device, the following must occur: (1) Publication of a proposed order 
in the Federal Register; (2) a meeting of a device classification panel 
described in section 513(b) of the FD&C Act; and (3) consideration of 
comments to a public docket.

II. Regulatory History of the Device

    FDA presented the complete regulatory history of these devices in 
the proposed order to reclassify iontophoresis devices for any other 
purposes, published in the Federal Register of September 22, 2014 (79 
FR 56532) (the ``proposed order''). The following are the most relevant 
pieces of the regulatory history of these devices. On August 28, 1979, 
the Agency published a proposed rule (44 FR 50520) for classification 
of all iontophoresis devices. On November 23, 1983, FDA issued a final 
rule in the Federal Register (48 FR 53032 at 53045) classifying 
iontophoresis devices into two different classes based on the device's 
intended use. Specifically, the rule classified iontophoresis devices 
into class II when intended to induce sweating for use in the diagnosis 
of cystic fibrosis or for other uses only when the labeling of the drug 
intended for use with the device bears adequate directions for the 
device's use with that drug (Sec.  890.5525(a) (21 CFR 890.5525(a))). 
These devices are currently under product code KTB. The rule classified 
iontophoresis devices into class III when intended for any other 
purposes (Sec.  890.5525(b)), but did not establish an effective date 
of requirement for premarket approval. These devices are currently 
under product code EGJ. In 2009, FDA published an order under section 
515(i) of the FD&C Act (the ``515(i) Order'') requiring manufacturers 
of remaining class III devices for which regulations requiring PMAs had 
not been issued, including iontophoresis devices (Sec.  890.5525(b)), 
to submit a summary of information concerning those devices by August 
7, 2009 (74 FR 16214, April 9, 2009).
    As discussed in the proposed order, FDA considered the available 
information on iontophoresis devices intended for any other purposes 
and concluded that these devices, which are prescription devices, could 
be reclassified to class II, subject to the special controls identified 
in the

[[Page 48705]]

proposed order, because there was sufficient information that these 
special controls, along with general controls, would provide reasonable 
assurance of safety and effectiveness. As required by section 513(e)(1) 
of the of the FD&C Act, FDA convened a meeting of a device 
classification panel described in section 513(b) of the FD&C Act, 
specifically the Orthopaedic and Rehabilitation Devices Panel (the 2014 
Panel), to discuss whether iontophoresis devices intended for any other 
purposes should be reclassified or remain in class III on February 21, 
2014 (Ref. 1). Please see the proposed order for additional information 
on the 2014 Panel. Ultimately, the panel concluded that sufficient 
information exists to establish special controls for these devices, and 
that special controls in combination with general controls could 
provide a reasonable assurance of safety and effectiveness; and thus, 
iontophoresis devices for any other purposes could be classified in 
class II.
    FDA received and has considered three sets of comments on this 
proposed order, as discussed in section III of this document. 
Therefore, FDA has met the requirements for issuing a final order under 
section 513(e)(1) of the FD&C Act. FDA is not aware of new information 
since the 2014 Panel meeting that would provide a basis for a different 
recommendation or finding.

III. Public Comments in Response to the Proposed Order

    In response to the proposed order, FDA received three sets of 
comments from various stakeholders. The comments and FDA's responses to 
the comments are summarized as follows.
    (Comment 1) One comment requested that iontophoresis devices 
intended for any other purposes remain classified in class III, and 
that FDA call for PMAs for these products. The commenter disagreed that 
general controls and special controls are sufficient to provide a 
reasonable assurance of safety and effectiveness because of, among 
other reasons, the commenter located, at the time of the 2014 Panel 
meeting, 40 adverse event reports for a 5-year period that implicated 
device malfunction, 12 of which include burns, in a search of the 
Manufacturer and User Facility Device Experience (MAUDE) database for 
iontophoresis devices intended for any other purposes. The commenter 
stated that manufacturing inspections during the PMA process would help 
ensure that iontophoresis devices are constructed properly and, 
therefore, be less likely to cause third degree burns and other 
injuries.
    (Response) FDA disagrees that iontophoresis devices intended for 
any other purposes should remain in class III and require PMA approval. 
As discussed in section V, ``Risks to Health,'' of the proposed order, 
these devices have certain risks to health; however, the Agency 
believes that those risks can be mitigated by the special controls. For 
example, the special controls include performance testing that will 
mitigate the risks of burns, insufficient or excessive drug delivery, 
and/or infection. Performance testing using a drug approved for 
iontophoretic delivery, or a solution, identified in the labeling, will 
ensure that device malfunction or use error is minimized. Additionally, 
performance testing will ensure that iontophoresis devices intended for 
any other purposes maintain a safe pH level to minimize burns from a 
large electrical current density or highly acidic solution. Based on 
FDA's review of the MAUDE database, the number of adverse event reports 
identified for iontophoresis devices intended for any other purposes 
has decreased over the last several years, supporting that the risk of 
injury is low. Furthermore, in the past decade, there have been no 
recalls for iontophoresis devices intended for any other purposes.
    (Comment 2) In addition, the commenter expressed concern that the 
special control requiring a labeling warning about adverse systemic 
effects was an insufficient safeguard because clinicians and patients 
may not see or read the label.
    (Response) FDA takes issue with this statement. As stated in the 
proposed order, iontophoresis devices are restricted to patient use 
only upon the authorization of a practitioner licensed by law to 
administer or use the device and the device identification in Sec.  
890.5525(b) has been revised to clarify that these are prescription 
devices in accordance with Sec.  801.109 (21 CFR 801.109). Per Sec.  
801.109(c), a prescription device, including iontophoresis devices 
intended for any other purposes, must include labeling that describes 
the indications and other information for use, such as methods, 
frequency and duration of administration, any relevant hazards, 
contraindications, side effects, and precautions under which the 
practitioners can use the device safely. Accordingly, clinicians will 
have access to and be aware of the warnings and precautions in the 
labeling, and as such, clinicians should be adequately informed of the 
risks associated with these devices. The clinician can inform the 
patients of the relevant risks. Therefore, the warning and precaution 
statements are an appropriate mitigation. FDA believes, therefore, that 
the special controls identified in this final order, in combination 
with general controls, will adequately mitigate the risks identified 
for iontophoresis devices intended for any other purposes and will 
provide a reasonable assurance of safety and effectiveness. FDA 
believes that iontophoresis devices may benefit patients by improving 
the noninvasive transdermal delivery of drugs or other solutions 
intended to treat various medical ailments or issues. As such, it is 
appropriate to reclassify these devices from class III (PMA) to class 
II (special controls). This is also the conclusion supported by the 
2014 Panel.
    (Comment 3) Two comments supported the reclassification of 
iontophoresis from class III to class II when these devices are 
intended for any other purposes. One comment, although overall 
supportive of reclassification, disagreed with the modified 
identification language and special controls. This comment asserted 
that the special controls, by requiring testing using a drug approved 
for iontophoretic delivery and labeling that contains language 
referring the user of the device to approved drug labeling, would 
create different regulatory paradigms for Sec.  890.5525(a) and (b), 
such that a new drug application (NDA) and 510(k) are needed for 
iontophoresis devices falling under paragraph (b) of the regulation, 
and that a 510(k) is needed for paragraph (a), although the devices are 
similar. The commenter uses iontophoresis devices that deliver 
pilocarpine for the diagnosis of cystic fibrosis, regulated under Sec.  
890.5525(a), as an example of this inconsistency.
    (Response) To the extent the commenter is raising issues related to 
products regulated under Sec.  890.5525(a), such products are not the 
subject of this reclassification; and as such, are not addressed here. 
However, we do note that the commenter's statement about two different 
regulatory paradigms is incorrect. As stated previously in this 
document and in the proposed order, whether an iontophoresis device 
falls into Sec.  890.5525(a) or (b), any drug that is intended to be 
used with these devices is required to have marketing authorization for 
iontophoretic administration of that drug. FDA intends to consider 
addressing the regulation of iontophoresis devices under Sec.  
890.5525(a) through a separate process.
    In addition, iontophoresis devices intended for any other purposes 
regulated under Sec.  890.5525(b) will need to comply with the 
applicable special

[[Page 48706]]

controls prior to entering the market. ``Any other purposes'' means 
that these devices are neither intended for use in the diagnosis of 
cystic fibrosis nor for use with a specific drug. Devices for any other 
purposes may include those intended for general iontophoretic delivery 
of drugs that are approved for that route of administration or intended 
for use with specific solutions. One example of an iontophoretic device 
for ``any other purposes'' is one indicated for use with tap water for 
treatment of hyperhidrosis.
    (Comment 4) The commenter also requested clarification on the 
identified risk of infection and the special control that states the 
patient-contacting elements of the device must be assessed for 
sterility.
    (Response) FDA believes that patient-contacting elements should be 
assessed for sterility if the device is labeled as sterile, and has 
clarified the special control in question (Sec.  890.5525(b)(2)(vi)) to 
specify such.

IV. The Final Order

    Based on the information discussed previously and in the preamble 
to the proposed order, the comments on the proposed order, a review of 
the MAUDE database, a review of current scientific literature, and 
panel deliberations (see the 2014 Panel transcript (Ref. 1)), FDA 
concludes that special controls, in conjunction with general controls, 
will provide reasonable assurance of the safety and effectiveness of 
iontophoresis devices intended for any other purposes. Under section 
513(e) of the FD&C Act, FDA is adopting its findings as published in 
the preamble to the proposed order, with the modification of the 
special control pertaining to sterility (Sec.  890.5525(b)(2)(vi)) to 
clarify that only devices labeled as sterile must have their patient-
contacting elements assessed for sterility. FDA is issuing this final 
order to reclassify iontophoresis devices intended for any other 
purposes from class III to class II and establish special controls by 
revising Sec.  890.5525(b).
    As noted previously, the identification for Sec.  890.5525(b) has 
been clarified to specify that devices intended to deliver specific 
drugs, including those drugs that may have adverse systemic effects, 
like fentanyl, are not considered part of this regulatory 
classification (Sec.  890.5525(b)(1)).
    Following the effective date of this final order, firms submitting 
a premarket notification (510(k)) for iontophoresis devices intended 
for any other purposes must comply with the applicable mitigation 
measures set forth in the codified special controls. This includes 
firms who are required to submit a new 510(k) under Sec.  807.81(a)(3) 
because the device is about to be significantly changed or modified. 
Additionally, a firm whose device was legally in commercial 
distribution before May 28, 1976, or whose device has been found to be 
substantially equivalent to such a device, must also comply with the 
special controls to remain legally on the market.
    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 devices. FDA has determined that premarket 
notification is necessary to provide reasonable assurance of safety and 
effectiveness of iontophoresis devices intended for any other purposes, 
and therefore, this device type is not exempt from premarket 
notification requirements.

V. 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.

VI. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of 
information found in 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, have been approved 
under OMB control number 0910-0120; and the collections of information 
under part 801 have been approved under OMB control number 0910-0485.
    In addition, FDA concludes that the labeling statement codified in 
this order does not constitute a ``collection of information'' under 
the PRA. Rather, the labeling statement is a public disclosure of 
information originally supplied by the Federal government to the 
recipient for the purpose of disclosure to the public (5 CFR 
1320.3(c)(2)).

VII. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act 
provided for FDA to issue regulations to reclassify devices. Although 
section 513(e) as amended requires FDA to issue final orders rather 
than regulations, FDASIA also provides for FDA to revoke previously 
promulgated regulations by order. FDA will continue to codify 
classifications and reclassifications in the Code of Federal 
Regulations (CFR). Changes resulting from final orders will appear in 
the CFR as changes to codified classification determinations or as 
newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the 
FD&C Act, as amended by FDASIA, in this final order, we are revoking 
the requirements in Sec.  890.5525(b) related to the classification of 
iontophoresis devices intended for any other purposes as class III 
devices and codifying the reclassification of iontophoresis device 
intended for any other purposes into class II (special controls).

VIII. 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. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. The panel transcript and other meeting materials for the February 
21, 2014, Orthopedic and Rehabilitation Devices Panel are available 
on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm386335.htm.

List of Subjects in 21 CFR Part 890

    Medical devices, Physical medicine devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, part 890 is 
amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for part 890 continues to read as follows:

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


0
2. In Sec.  890.5525 revise paragraph (b) and remove paragraph (c) to 
read as follows:


Sec.  890.5525  Iontophoresis device.

* * * * *

[[Page 48707]]

    (b) Iontophoresis device intended for any other purposes--(1) 
Identification. An iontophoresis device intended for any other purposes 
is a prescription device that is intended to use a current to introduce 
ions of drugs or non-drug solutions into the body for medical purposes 
other than those specified in paragraph (a) of this section, meaning 
that the device is not intended for use in diagnosis of cystic 
fibrosis, or a specific drug is not specified in the labeling of the 
iontophoresis device.
    (2) Classification. Class II (special controls). The device is 
classified as class II. The special controls for this device are:
    (i) The following performance testing must be conducted:
    (A) Testing using a drug approved for iontophoretic delivery, or a 
solution, if identified in the labeling, to demonstrate safe use of the 
device as intended;
    (B) Testing of the ability of the device to maintain a safe pH 
level; and
    (C) If used in the ear, testing of the device to demonstrate 
mechanical safety.
    (ii) Labeling must include adequate instructions for use, including 
sufficient information for the health care provider to determine the 
device characteristics that affect delivery of the drug or solution and 
to select appropriate drug or solution dosing information for 
administration by iontophoresis. This includes the following:
    (A) A description and/or graphical representation of the electrical 
output;
    (B) A description of the electrode materials and pH buffer;
    (C) When intended for general drug delivery, language referring the 
user to drug labeling approved for iontophoretic delivery to determine 
if the drug they intend to deliver is specifically approved for use 
with that type of device and to obtain relevant dosing information; and
    (D) A detailed summary of the device-related and procedure-related 
complications pertinent to use of the device, and appropriate warnings 
and contraindications, including the following warning:
    Warning: Potential systemic adverse effects may result from use of 
this device. Drugs or solutions delivered with this device have the 
potential to reach the blood stream and cause systemic effects. 
Carefully read all labeling of the drug or solution used with this 
device to understand all potential adverse effects and to ensure 
appropriate dosing information. If systemic manifestations occur, refer 
to the drug or solution labeling for appropriate action.
    (iii) Appropriate analysis/testing must demonstrate electromagnetic 
compatibility, electrical safety, thermal safety, and mechanical 
safety.
    (iv) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (v) The elements of the device that may contact the patient must be 
demonstrated to be biocompatible.
    (vi) The elements of the device that may contact the patient must 
be assessed for sterility, for devices labeled as sterile.
    (vii) Performance data must support the shelf life of the elements 
of the device that may be affected by aging by demonstrating continued 
package integrity and device functionality over the stated shelf life.

    Dated: July 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17609 Filed 7-25-16; 8:45 am]
BILLING CODE 4164-01-P
Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Rules and Regulations 48703

§ 522.2471 [Amended] § 558.355 [Amended] § 558.630 [Amended]

■ 16. In § 522.2471, in paragraph (b), ■ 27. In § 558.355, in paragraphs (b)(1) ■ 34. In § 558.630, in paragraph (b)(1),
remove ‘‘000986’’ and in its place add and (2), (b)(4) through (9), (b)(11) and remove ‘‘000986’’ and in its place add
‘‘058198’’. (12), and (b)(14), in paragraphs ‘‘058198’’.
(f)(1)(xiii)(b), (f)(1)(xxi)(b), (f)(1)(xxii)(b), § 558.665 [Amended]
§ 22.2476 [Amended]
(f)(1)(xxviii)(b), (f)(1)(xxix)(b),
■ 35. In § 558.665, in paragraphs (e)(2),
■ 17. In § 522.2476, in paragraph (a)(1), (f)(1)(xxxi)(b), paragraphs
(3), (4), (5), (6), (8), (10), (11), and (12),
remove ‘‘021641’’ and in its place add (f)(3)(i)(b)(2)(iii), (f)(3)(ii)(b),
in the ‘‘Limitations’’ column, remove
‘‘058198’’. (f)(3)(xii)(b), in paragraphs (f)(4)(ii)(b)
‘‘000986’’ wherever it occurs and in its
and (f)(4)(iii)(b), and in paragraph
§ 522.2477 [Amended] place add ‘‘058198’’; and in paragraphs
(f)(6)(i)(b)(2)(iii), remove ‘‘000986’’ and
(e)(2), (3), (4), and (6), in the ‘‘Sponsor’’
■ 18. In § 522.2477, in paragraph (b)(1), in its place add ‘‘058198’’. column, remove ‘‘000986’’ and in its
remove ‘‘000986’’ and in its place add place add ‘‘058198’’.
§ 558.363 [Amended]
‘‘058198’’.
Dated: July 20, 2016.
§ 522.2640 [Amended] ■ 28. In § 558.363, in paragraphs (a)(1), William T. Flynn,
(3), and (8), and in paragraphs
Acting Director, Center for Veterinary
■ 19. In § 522.2640, in paragraph (b)(1), (d)(1)(ii)(B), (d)(1)(iii)(B), (d)(1)(iv)(B), Medicine.
remove ‘‘000986’’ and in its place add (d)(1)(v)(B), and (d)(1)(vi)(B), remove
[FR Doc. 2016–17501 Filed 7–25–16; 8:45 am]
‘‘058198’’. ‘‘000986’’ and in its place add
BILLING CODE 4164–01–P
‘‘058198’’.
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW § 558.366 [Amended]
ANIMAL DRUGS DEPARTMENT OF HEALTH AND
■ 29. In § 558.366, in paragraph (b), HUMAN SERVICES
■ 20. The authority citation for part 524 remove ‘‘000986’’ and in its place add
‘‘058198’’; and in paragraph (d), in the Food and Drug Administration
continues to read as follows:
six row entries beginning in the
Authority: 21 U.S.C. 360b. ‘‘Nicarbazin in grams per ton’’ column 21 CFR Part 890
§ 524.916 [Amended] with ‘‘27 to 45’’, in the ‘‘Limitations’’ [Docket No. FDA–2000–N–0158]
and ‘‘Sponsor’’ columns, remove
■ 21. In § 524.916, in paragraph (b), ‘‘000986’’ wherever it occurs and in its Physical Medicine Devices;
remove ‘‘000986’’ and in its place add place add ‘‘058198’’. Reclassification of Iontophoresis
‘‘058198’’. Device Intended for Any Other
§ 558.500 [Amended] Purposes
§ 524.1445 [Amended]
■ 30. In § 558.500, in paragraph (b), AGENCY: Food and Drug Administration,
■ 22. In § 524.1445, in paragraph (b), remove ‘‘000986 and 054771’’ and in its
remove ‘‘000986’’ and in its place add HHS.
place add ‘‘054771 and 058198’’; and in ACTION: Final order.
‘‘058198’’. paragraphs (e)(1)(i) through (iv) and
PART 558—NEW ANIMAL DRUGS FOR (e)(2)(i) through (xiii), in the SUMMARY: The Food and Drug
USE IN ANIMAL FEEDS ‘‘Limitations’’ and ‘‘Sponsor’’ columns, Administration (FDA) is issuing a final
remove ‘‘000986’’ wherever it occurs order to reclassify iontophoresis devices
and in its place add ‘‘058198’’; and in intended for any other purposes, which
■ 23. The authority citation for part 558
paragraphs (e)(3)(i) through (iv), in the are preamendments class III devices
continues to read as follows:
‘‘Sponsor’’ column, remove ‘‘000986’’ (regulated under product code EGJ), into
Authority: 21 U.S.C. 354, 360b, 360ccc, wherever it occurs and in its place add class II (special controls) and to amend
360ccc–1, 371. ‘‘058198’’. the device identification to clarify that
§ 558.68 [Amended] devices intended to deliver specific
§ 558.550 [Amended] drugs are not considered part of this
■ 24. In § 558.68, in paragraph (b), regulatory classification.
remove ‘‘000986’’ and in its place add ■ 31. In § 558.550, in paragraph
(d)(1)(xxii)(B), remove ‘‘000986 and DATES: This order is effective on July 26,
‘‘058198’’. 2016.
016592’’ and in its place add ‘‘016592
§ 558.274 [Amended] and 058198’’. FOR FURTHER INFORMATION CONTACT:
Jismi Johnson, Center for Devices and
■ 25. In § 558.274, in paragraph (a)(1), § 558.618 [Amended] Radiological Health, 10903 New
remove ‘‘000986’’ and in its place add Hampshire Ave., Bldg. 66, Rm. 1524,
‘‘058198’’; and in paragraphs (c)(1)(i) ■ 32. In § 558.618, in paragraph (b), Silver Spring, MD 20993, 301–796–
and (ii) and (c)(2)(i) and (ii), in the remove ‘‘000986 and 016592’’ and in its 6424, jismi.johnson@fda.hhs.gov.
‘‘Sponsor’’ column, remove ‘‘000986’’ place add ‘‘016592 and 058198’’; and in
SUPPLEMENTARY INFORMATION:
and in its place add ‘‘058198’’. paragraphs (e)(1)(i) and (e)(2)(i) through
(iii), in the ‘‘Sponsor’’ column, remove I. Background—Regulatory Authorities
§ 558.342 [Amended] ‘‘000986’’ and in its place add The Federal Food, Drug, and Cosmetic
rmajette on DSK2TPTVN1PROD with RULES

■ 26. In § 558.342, in paragraph (b)(2), ‘‘058198’’. Act (the FD&C Act), as amended by the
remove ‘‘000986’’ and in its place add § 558.625 [Amended] Medical Device Amendments of 1976
‘‘058198’’; and in paragraphs (e)(1)(i) (the 1976 amendments) (Pub. L. 94–
through (iv) and (e)(1)(ix) and (x), in the ■ 33. In § 558.625, in paragraph (b)(1), 295), the Safe Medical Devices Act of
‘‘Sponsor’’ column, remove ‘‘000986’’ remove ‘‘To 000986’’ and in its place 1990 (Pub. L. 101–629), the Food and
and in its place add ‘‘058198’’. add ‘‘No. 058198’’. Drug Administration Modernization Act

VerDate Sep<11>2014 13:45 Jul 25, 2016 Jkt 238001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\26JYR1.SGM 26JYR1
48704 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Rules and Regulations

of 1997 (Pub. L. 105–115), the Medical does not require premarket approval. (See section 520(c) of the FD&C Act (21
Device User Fee and Modernization Act The Agency determines whether new U.S.C. 360j(c)).)
of 2002 (Pub. L. 107–250), the Medical devices are substantially equivalent to Section 513(e)(1) of the FD&C Act sets
Devices Technical Corrections Act (Pub. predicate devices by means of forth the process for issuing a final order
L. 108–214), the Food and Drug premarket notification procedures in to reclassify a device under that section.
Administration Amendments Act of section 510(k) of the FD&C Act (21 Specifically, prior to the issuance of a
2007 (Pub. L. 110–85), and the Food and U.S.C. 360(k)) and part 807 (21 CFR part final order reclassifying a device, the
Drug Administration Safety and 807). following must occur: (1) Publication of
Innovation Act (FDASIA) (Pub. L. 112– On July 9, 2012, FDASIA was enacted. a proposed order in the Federal
144), among other amendments, Section 608(a) of FDASIA amended Register; (2) a meeting of a device
established a comprehensive system for section 513(e) of the FD&C Act, classification panel described in section
the regulation of medical devices changing the mechanism for 513(b) of the FD&C Act; and (3)
intended for human use. Section 513 of reclassifying a device under that section consideration of comments to a public
the FD&C Act (21 U.S.C. 360c) from rulemaking to an administrative docket.
established three categories (classes) of order. II. Regulatory History of the Device
devices, reflecting the regulatory Section 513(e) of the FD&C Act
controls needed to provide reasonable FDA presented the complete
governs reclassification of classified
assurance of their safety and regulatory history of these devices in the
devices. This section provides that FDA
effectiveness. The three categories of proposed order to reclassify
may, by administrative order, reclassify
devices are class I (general controls), iontophoresis devices for any other
a device based on ‘‘new information.’’
class II (special controls), and class III purposes, published in the Federal
FDA can initiate a reclassification under Register of September 22, 2014 (79 FR
(premarket approval). section 513(e) of the FD&C Act or an
Under section 513(d) of the FD&C Act, 56532) (the ‘‘proposed order’’). The
interested person may petition FDA to following are the most relevant pieces of
devices that were in commercial reclassify a preamendments device. The
distribution before the enactment of the the regulatory history of these devices.
term ‘‘new information,’’ as used in On August 28, 1979, the Agency
1976 amendments, May 28, 1976 section 513(e), includes information
(generally referred to as preamendments published a proposed rule (44 FR
developed as a result of a reevaluation 50520) for classification of all
devices), are classified after FDA has: (1) of the data before the Agency when the
Received a recommendation from a iontophoresis devices. On November 23,
device was originally classified, as well 1983, FDA issued a final rule in the
device classification panel (an FDA
as information not presented, not Federal Register (48 FR 53032 at 53045)
advisory committee); (2) published the
available, or not developed at that time. classifying iontophoresis devices into
panel’s recommendation for comment,
(See, e.g., Holland-Rantos Co. v. United two different classes based on the
along with a proposed regulation
States Department of Health, Education, device’s intended use. Specifically, the
classifying the device; and (3) published
and Welfare, 587 F.2d 1173, 1174 n.1 rule classified iontophoresis devices
a final regulation classifying the device.
(D.C. Cir. 1978); Upjohn v. Finch, 422 into class II when intended to induce
FDA has classified most
F.2d 944 (6th Cir. 1970); Bell v. sweating for use in the diagnosis of
preamendments devices under these
Goddard, 366 F.2d 177 (7th Cir. 1966).) cystic fibrosis or for other uses only
procedures.
A preamendments device that has Reevaluation of the data previously when the labeling of the drug intended
been classified into class III and devices before the Agency is an appropriate for use with the device bears adequate
found substantially equivalent by means basis for subsequent action where the directions for the device’s use with that
of premarket notification procedures reevaluation is made in light of newly drug (§ 890.5525(a) (21 CFR
(510(k)) to such a preamendments available authority (see Bell, 366 F.2d at 890.5525(a))). These devices are
device or to a device within that type 181; Ethicon, Inc. v. FDA, 762 F.Supp. currently under product code KTB. The
(both the preamendments and 382, 388–391 (D.D.C. 1991)), or in light rule classified iontophoresis devices
substantially equivalent devices are of changes in ‘‘medical science’’ into class III when intended for any
referred to as preamendments class III (Upjohn, 422 F.2d at 951). Whether data other purposes (§ 890.5525(b)), but did
devices) may be marketed without before the Agency are old or new data, not establish an effective date of
submission of a premarket approval the ‘‘new information’’ to support requirement for premarket approval.
application (PMA) until FDA issues a reclassification under section 513(e) These devices are currently under
final order under section 515(b) of the must be ‘‘valid scientific evidence,’’ as product code EGJ. In 2009, FDA
FD&C Act (21 U.S.C. 360e(b)) requiring defined in section 513(a)(3) of the FD&C published an order under section 515(i)
premarket approval or until the device Act and 21 CFR 860.7(c)(2). (See, e.g., of the FD&C Act (the ‘‘515(i) Order’’)
is subsequently reclassified into class I General Medical Co. v. FDA, 770 F.2d requiring manufacturers of remaining
or class II. 214 (D.C. Cir. 1985); Contact Lens class III devices for which regulations
Devices that were not in commercial Association v. FDA, 766 F.2d 592 (D.C. requiring PMAs had not been issued,
distribution prior to May 28, 1976 Cir. 1985), cert. denied, 474 U.S. 1062 including iontophoresis devices
(generally referred to as (1986).) (§ 890.5525(b)), to submit a summary of
postamendments devices) are FDA relies upon ‘‘valid scientific information concerning those devices by
automatically classified by section evidence’’ in the classification process August 7, 2009 (74 FR 16214, April 9,
513(f) of the FD&C Act into class III to determine the level of regulation for 2009).
without any FDA rulemaking process. devices. To be considered in the As discussed in the proposed order,
Those devices remain in class III and reclassification process, the ‘‘valid FDA considered the available
rmajette on DSK2TPTVN1PROD with RULES

require premarket approval unless, and scientific evidence’’ upon which the information on iontophoresis devices
until, the device is reclassified into class Agency relies must be publicly intended for any other purposes and
I or II or FDA issues an order finding the available. Publicly available information concluded that these devices, which are
device to be substantially equivalent, in excludes trade secret and/or prescription devices, could be
accordance with section 513(i) of the confidential commercial information, reclassified to class II, subject to the
FD&C Act, to a predicate device that e.g., the contents of a pending PMA. special controls identified in the

VerDate Sep<11>2014 13:45 Jul 25, 2016 Jkt 238001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\26JYR1.SGM 26JYR1
48706 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Rules and Regulations

controls prior to entering the market. in the codified special controls. This amended requires FDA to issue final
‘‘Any other purposes’’ means that these includes firms who are required to orders rather than regulations, FDASIA
devices are neither intended for use in submit a new 510(k) under also provides for FDA to revoke
the diagnosis of cystic fibrosis nor for § 807.81(a)(3) because the device is previously promulgated regulations by
use with a specific drug. Devices for any about to be significantly changed or order. FDA will continue to codify
other purposes may include those modified. Additionally, a firm whose classifications and reclassifications in
intended for general iontophoretic device was legally in commercial the Code of Federal Regulations (CFR).
delivery of drugs that are approved for distribution before May 28, 1976, or Changes resulting from final orders will
that route of administration or intended whose device has been found to be appear in the CFR as changes to codified
for use with specific solutions. One substantially equivalent to such a classification determinations or as
example of an iontophoretic device for device, must also comply with the newly codified orders. Therefore, under
‘‘any other purposes’’ is one indicated special controls to remain legally on the section 513(e)(1)(A)(i) of the FD&C Act,
for use with tap water for treatment of market. as amended by FDASIA, in this final
hyperhidrosis. Section 510(m) of the FD&C Act order, we are revoking the requirements
(Comment 4) The commenter also provides that FDA may exempt a class in § 890.5525(b) related to the
requested clarification on the identified II device from the premarket notification classification of iontophoresis devices
risk of infection and the special control requirements under section 510(k) of the intended for any other purposes as class
that states the patient-contacting FD&C Act if FDA determines that III devices and codifying the
elements of the device must be assessed premarket notification is not necessary reclassification of iontophoresis device
for sterility. to provide reasonable assurance of the intended for any other purposes into
(Response) FDA believes that patient- safety and effectiveness of the devices. class II (special controls).
contacting elements should be assessed FDA has determined that premarket
for sterility if the device is labeled as notification is necessary to provide VIII. Reference
sterile, and has clarified the special reasonable assurance of safety and The following reference is on display
control in question (§ 890.5525(b)(2)(vi)) effectiveness of iontophoresis devices in the Division of Dockets Management
to specify such. intended for any other purposes, and (HFA–305) Food and Drug
IV. The Final Order therefore, this device type is not exempt Administration, 5630 Fishers Lane, Rm.
from premarket notification 1061, Rockville, MD 20852, and is
Based on the information discussed available for viewing by interested
requirements.
previously and in the preamble to the persons between 9 a.m. and 4 p.m.,
proposed order, the comments on the V. Analysis of Environmental Impact
Monday through Friday; it is also
proposed order, a review of the MAUDE The Agency has determined under 21 available electronically at http://
database, a review of current scientific CFR 25.34(b) that this action is of a type www.regulations.gov. FDA has verified
literature, and panel deliberations (see that does not individually or the Web site address, as of the date this
the 2014 Panel transcript (Ref. 1)), FDA cumulatively have a significant effect on document publishes in the Federal
concludes that special controls, in the human environment. Therefore, Register, but Web sites are subject to
conjunction with general controls, will neither an environmental assessment change over time.
provide reasonable assurance of the nor an environmental impact statement
safety and effectiveness of iontophoresis 1. The panel transcript and other meeting
is required. materials for the February 21, 2014,
devices intended for any other
VI. Paperwork Reduction Act of 1995 Orthopedic and Rehabilitation Devices
purposes. Under section 513(e) of the
Panel are available on FDA’s Web site at
FD&C Act, FDA is adopting its findings This final order refers to previously http://www.fda.gov/AdvisoryCommittees/
as published in the preamble to the approved collections of information CommitteesMeetingMaterials/Medical
proposed order, with the modification found in FDA regulations. These Devices/MedicalDevicesAdvisory
of the special control pertaining to collections of information are subject to Committee/OrthopaedicandRehabilitation
sterility (§ 890.5525(b)(2)(vi)) to clarify review by the Office of Management and DevicesPanel/ucm386335.htm.
that only devices labeled as sterile must Budget (OMB) under the Paperwork List of Subjects in 21 CFR Part 890
have their patient-contacting elements Reduction Act of 1995 (44 U.S.C. 3501–
assessed for sterility. FDA is issuing this 3520). The collections of information in Medical devices, Physical medicine
final order to reclassify iontophoresis part 807, subpart E, have been approved devices.
devices intended for any other purposes under OMB control number 0910–0120; Therefore, under the Federal Food,
from class III to class II and establish and the collections of information under Drug, and Cosmetic Act and under
special controls by revising part 801 have been approved under authority delegated to the Commissioner
§ 890.5525(b). OMB control number 0910–0485. of Food and Drugs, part 890 is amended
As noted previously, the In addition, FDA concludes that the as follows:
identification for § 890.5525(b) has been labeling statement codified in this order
clarified to specify that devices does not constitute a ‘‘collection of PART 890—PHYSICAL MEDICINE
intended to deliver specific drugs, information’’ under the PRA. Rather, the DEVICES
including those drugs that may have labeling statement is a public disclosure
adverse systemic effects, like fentanyl, ■ 1. The authority citation for part 890
of information originally supplied by
are not considered part of this continues to read as follows:
the Federal government to the recipient
regulatory classification for the purpose of disclosure to the Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
rmajette on DSK2TPTVN1PROD with RULES

(§ 890.5525(b)(1)). public (5 CFR 1320.3(c)(2)).
Following the effective date of this ■ 2. In § 890.5525 revise paragraph (b)
final order, firms submitting a VII. Codification of Orders
and remove paragraph (c) to read as
premarket notification (510(k)) for Prior to the amendments by FDASIA, follows:
iontophoresis devices intended for any section 513(e) of the FD&C Act provided
other purposes must comply with the for FDA to issue regulations to reclassify § 890.5525 Iontophoresis device.
applicable mitigation measures set forth devices. Although section 513(e) as * * * * *

VerDate Sep<11>2014 13:45 Jul 25, 2016 Jkt 238001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\FR\FM\26JYR1.SGM 26JYR1
Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Rules and Regulations 48707

(b) Iontophoresis device intended for (iii) Appropriate analysis/testing must services. Section 83(a) of the Code
any other purposes—(1) Identification. demonstrate electromagnetic provides generally that the excess of the
An iontophoresis device intended for compatibility, electrical safety, thermal fair market value of the transferred
any other purposes is a prescription safety, and mechanical safety. property (determined without regard to
device that is intended to use a current (iv) Appropriate software verification, any restriction other than a restriction
to introduce ions of drugs or non-drug validation, and hazard analysis must be which by its terms will never lapse) as
solutions into the body for medical performed. of the first time that the transferee’s
purposes other than those specified in (v) The elements of the device that rights in the property are transferable or
paragraph (a) of this section, meaning may contact the patient must be are not subject to a substantial risk of
that the device is not intended for use demonstrated to be biocompatible. forfeiture, whichever occurs earlier,
in diagnosis of cystic fibrosis, or a (vi) The elements of the device that over the amount (if any) paid for the
specific drug is not specified in the may contact the patient must be property is included in the service
labeling of the iontophoresis device. assessed for sterility, for devices labeled provider’s gross income for the taxable
(2) Classification. Class II (special as sterile. year which includes such time. Section
controls). The device is classified as (vii) Performance data must support 83(b) and § 1.83–2(a) permit the service
class II. The special controls for this the shelf life of the elements of the provider to elect to include in gross
device are: device that may be affected by aging by income, as compensation for services,
(i) The following performance testing demonstrating continued package the excess (if any) of the fair market
must be conducted: integrity and device functionality over value of the property at the time of
(A) Testing using a drug approved for the stated shelf life. transfer over the amount (if any) paid
iontophoretic delivery, or a solution, if Dated: July 20, 2016. for the property. Under section 83(b)(2),
identified in the labeling, to an election under section 83(b) must be
Leslie Kux,
demonstrate safe use of the device as made in accordance with the regulations
intended; Associate Commissioner for Policy. thereunder. Under § 1.83–2(c), the
(B) Testing of the ability of the device [FR Doc. 2016–17609 Filed 7–25–16; 8:45 am] election must be filed with the IRS no
to maintain a safe pH level; and BILLING CODE 4164–01–P later than 30 days after the date on
(C) If used in the ear, testing of the which the property is transferred, and a
device to demonstrate mechanical copy of the election must be submitted
safety. DEPARTMENT OF THE TREASURY with the taxpayer’s income tax return
(ii) Labeling must include adequate for the taxable year in which the
instructions for use, including sufficient Internal Revenue Service property is transferred.
information for the health care provider On July 17, 2015, the Department of
to determine the device characteristics 26 CFR Part 1 the Treasury (Treasury) and the Internal
that affect delivery of the drug or [TD 9779] Revenue Service (IRS) published a
solution and to select appropriate drug notice of proposed rulemaking (REG–
or solution dosing information for RIN 1545–BM63 135524–14) in the Federal Register (137
administration by iontophoresis. This FR 42439) under section 83 of the Code
includes the following: Property Transferred in Connection eliminating the requirement that a copy
(A) A description and/or graphical With the Performance of Services of a section 83(b) election be submitted
representation of the electrical output; AGENCY: Internal Revenue Service, with the taxpayer’s income tax return
(B) A description of the electrode Department of Treasury. for the taxable year in which the
materials and pH buffer; property is transferred. Treasury and the
ACTION: Final regulations.
(C) When intended for general drug IRS received no comments responding
delivery, language referring the user to SUMMARY: This document contains final to the notice of proposed rulemaking.
drug labeling approved for regulations relating to property No public hearing was requested and no
iontophoretic delivery to determine if transferred in connection with the public hearing was held. Treasury and
the drug they intend to deliver is performance of services. These final the IRS now adopt the proposed
specifically approved for use with that regulations affect certain taxpayers who regulations as final regulations without
type of device and to obtain relevant receive property transferred in modification.
dosing information; and connection with the performance of
(D) A detailed summary of the device- Explanation of Provisions
services and make an election to include
related and procedure-related the value of substantially nonvested These final regulations remove the
complications pertinent to use of the property in income in the year of second sentence in § 1.83–2(c) of the
device, and appropriate warnings and transfer. existing regulations, which requires that
contraindications, including the a taxpayer submit a copy of a section
following warning: DATES: Effective Date: These regulations 83(b) election with the taxpayer’s tax
Warning: Potential systemic adverse are effective on July 26, 2016. return for the year in which the property
effects may result from use of this Applicability Date: For dates of subject to the election was transferred.
device. Drugs or solutions delivered applicability, see § 1.83–2(g). Accordingly, under these final
with this device have the potential to FOR FURTHER INFORMATION CONTACT: regulations, a taxpayer is no longer
reach the blood stream and cause Thomas Scholz or Michael Hughes at required to file a copy of a section 83(b)
systemic effects. Carefully read all (202) 317–5600 (not a toll-free number). election with the taxpayer’s income tax
labeling of the drug or solution used
rmajette on DSK2TPTVN1PROD with RULES

SUPPLEMENTARY INFORMATION: return.
with this device to understand all Taxpayers are reminded of their
potential adverse effects and to ensure Background general recordkeeping responsibilities
appropriate dosing information. If Section 83 of the Internal Revenue pursuant to section 6001 of the Code,
systemic manifestations occur, refer to Code (Code) addresses the tax and more specifically of the need to
the drug or solution labeling for consequences of a transfer of property in keep records that show the basis of
appropriate action. connection with the performance of property owned by the taxpayer.

VerDate Sep<11>2014 13:45 Jul 25, 2016 Jkt 238001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\26JYR1.SGM 26JYR1
Document Created: 2018-02-08 08:00:37
Document Modified: 2018-02-08 08:00:37
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 on July 26, 2016.
Contact		Jismi Johnson, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993, 301-796-6424, [email protected]
FR Citation		81 FR 48703
CFR Associated		Medical Devices and Physical Medicine Devices
81 FR 48703 - Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 143 (July 26, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
