[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Rules and Regulations]
[Pages 72585-72586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29638]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. FDA-2014-N-1243]


Dental Devices; Reclassification of Electrical Salivary 
Stimulator System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final 
order to reclassify the salivary stimulator system, a postamendments 
Class III device, into class II (special controls) and to rename the 
device the ``electrical salivary stimulator system.'' 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 December 21, 2015.

FOR FURTHER INFORMATION CONTACT: Michael Ryan, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993, 301-796-6283.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as 
amended, 21 U.S.C. 301 et seq., establishes 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).
    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)(1) 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).
    A postamendments device that has been initially classified in class 
III under section 513(f)(1) of the FD&C Act may be reclassified into 
class I or class II under section 513(f)(3) of the FD&C Act. Section 
513(f)(3) provides that FDA acting by order can reclassify the device 
into class I or class II on its own initiative, or in response to a 
petition from the manufacturer or importer of the device. To change the 
classification of the device, the proposed new class must have 
sufficient regulatory controls to provide reasonable assurance of the 
safety and effectiveness of the device for its intended use.
    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 regulatory authority (see Bell v. Goddard, 
366 F.2d 177, 181 (7th Cir. 1966); Ethicon, Inc. v. FDA, 762 F. Supp. 
382, 388-391 (D.D.C. 1991)), or in light of changes in ``medical 
science'' (Upjohn v. Finch, 422 F.2d 944, 951 (6th Cir. 1970)). Whether 
data before the Agency are old or new, the ``new information'' to 
support reclassification under section 513(f)(3) of the FD&C Act must 
be ``valid scientific evidence'', as defined in section 513(a)(3) 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 Mfrs. Assoc. 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 
premarket approval application (PMA) (see section 520(c) of the FD&C 
Act (21 U.S.C. 360j(c)).
    On September 18, 2014, FDA published an order in the Federal 
Register to reclassify the device (79 FR 56027) (the ``proposed 
order''). The period for public comment on the proposed order closed on 
December 17, 2014. FDA received and has considered 20 comments on the 
proposed order, as discussed in section II.

II. Public Comments in Response to the Proposed Order

    Of the 20 public comments that FDA received in response to the 
proposed order, 17 comments supported the proposed reclassification and 
3 comments were opposed. All of the commenters were individuals, 12 of 
whom identified themselves as medical practitioners. Eight of these 12 
practitioners claimed prior research experience with the device. Three 
commenters claimed experience with the device as patients in clinical 
trials.
    All of the practitioners' and patients' comments were supportive of 
the reclassification proposal. All of the practitioners with prior 
experience administering the device noted favorable results for some of 
their patients and no adverse events. The other four practitioners who 
commented either had recommended, or if available would recommend, the 
device as a non-pharmaceutical option for treating dry mouth 
conditions.
    Five commenters did not claim any prior professional or patient 
experience with the device. Of these comments, two favored finalization 
of the proposed reclassification based on the evidence presented in the 
proposed order.
    Three comments opposed the proposed reclassification. None of these 
commenters claimed prior professional or patient experience with the 
device. One commenter believed that the proposed order adequately 
addressed safety concerns but failed to provide convincing evidence of 
the effectiveness of the device.
    FDA disagrees with the comment. The special control requiring 
documented clinical experience will allow the Agency to require 
information on each device's effectiveness in actual clinical use.
    Two commenters believed that the devices should undergo further 
clinical trials to evaluate device and human factors risks, and that 
electrically powered salivary stimulators are inherently hazardous and 
subject to misuse and, without conclusive test results, should continue 
to be classified as Class III devices and be subject to premarket 
approval.
    The Agency disagrees that electrical salivary stimulator systems 
should

[[Page 72586]]

remain class III and subject to premarket approval. The Agency believes 
that the special controls required in this final order provide a 
reasonable assurance of safety and effectiveness for these devices. FDA 
believes it has identified the risks to health (see section VI of the 
proposed order) and that the mitigation measures described in the final 
order will be effective in mitigating the risks described in the two 
comments, including the risks associated with the low-voltage 
electrical features of the devices. In particular, the special control 
requiring documented clinical experience will allow the Agency to 
require information on each device's safety and effectiveness in actual 
clinical use, including any human factors risks. These devices utilize 
technology similar to that used in other class II medical devices such 
as transcutaneous electrical nerve stimulators. The Agency believes 
that its experience with similar devices and the lack of adverse events 
for salivary stimulators in FDA's Manufacturer and User Facility Device 
Experience (MAUDE) database and peer-reviewed literature provide 
sufficient information to establish special controls that mitigated the 
risks to health identified for this device type in the proposed order.
    The Agency is making a minor modification to the proposed special 
controls for electrical salivary stimulator systems by replacing the 
term ``geometry'' in the first special control with the term ``device 
design.'' FDA makes this revision to clarify the intent of the special 
control.

III. The Final Order

    Under section 513(f)(3) of the FD&C Act, FDA is adopting its 
findings as published in the preamble to the proposed order. FDA is 
issuing this final order to reclassify salivary stimulator system 
devices from class III to class II, rename them electrical salivary 
stimulator systems, and establish special controls by revising part 872 
(21 CFR part 872).
    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 electrical salivary stimulator systems, and therefore, 
this device type is not exempt from premarket notification 
requirements.
    The device is assigned the generic name electrical salivary 
stimulator system, and it is identified as a prescription intraoral 
device intended to electrically stimulate a relative increase in saliva 
production. FDA is identifying the device under this new name to 
distinguish it from other devices that stimulate saliva flow via non-
electrical means.
    Under this final order, the electrical salivary stimulatory system 
device is a prescription device restricted to patient use only upon the 
authorization of a dental practitioner or physician licensed by law to 
administer or use the device (see 21 CFR 801.109 (Prescription 
devices)). Prescription-use restrictions are a type of general control 
defined in section 513(a)(1)(A)(i) of the FD&C Act. The labeling of the 
device must bear all information required for the safe and effective 
use of prescription devices as outlined in Sec.  801.109.
    Under section 513(f)(3) of the FD&C Act, FDA is adopting its 
findings as published in the preamble to the proposed order, with the 
following correction: FDA stated in the proposed order that the Agency 
utilized section 520(h)(4) of the FD&C Act to review data contained in 
premarket approval applications (PMAs) approved 6 or more years before 
the date of the proposed order. The Agency would like to clarify that 
this language was included unintentionally, and that the provisions of 
section 520(h)(4) were not utilized in this rulemaking proceeding.

IV. Environmental Impact, No Significant Impact

    We have 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.

V. Paperwork Reduction Act of 1995

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

List of Subjects in 21 CFR Part 872

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq., as amended) and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR part 872 is amended as follows:

PART 872--DENTAL DEVICES

0
1. The authority citation for 21 CFR part 872 continues to read as 
follows:


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


0
2. Add Sec.  872.5560 to subpart F to read as follows:


Sec.  872.5560  Electrical salivary stimulatory system.

    (a) Identification. An electrical salivary stimulatory system is a 
prescription intraoral device that is intended to electrically 
stimulate a relative increase in saliva production.
    (b) Classification--Class II (special controls). The special 
controls for this device are:
    (1) The design characteristics of the device must ensure that the 
device design, material composition, and electrical output 
characteristics are consistent with the intended use;
    (2) Any element of the device that contacts the patient must be 
demonstrated to be biocompatible;
    (3) Appropriate analysis and/or testing must validate 
electromagnetic compatibility and electrical safety, including the 
safety of any battery used in the device;
    (4) Software validation, verification, and hazard testing must be 
performed; and
    (5) Documented clinical experience must demonstrate safe and 
effective use for stimulating saliva production by addressing the risks 
of damage to intraoral tissue and of ineffective treatment and must 
capture any adverse events observed during clinical use.

    Dated: November 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29638 Filed 11-19-15; 8:45 am]
 BILLING CODE 4164-01-P