[Federal Register Volume 79, Number 181 (Thursday, September 18, 2014)]
[Proposed Rules]
[Pages 56027-56029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22255]



[[Page 56027]]

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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 Salivary Stimulatory System, 
To Be Renamed Electrical Salivary Stimulator System

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed Order.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify salivary stimulatory system, a class III device, into class 
II (special controls), subject to premarket notification. FDA is also 
identifying the proposed special controls that the Agency believes will 
provide a reasonable assurance of safety and effectiveness of the 
device. The Agency is proposing to rename the device ``electrical 
salivary stimulatory system.''

DATES: Submit either electronic or written comments by December 17, 
2014. Please see section IX of this document for the proposed effective 
date of any final order that may publish based on this proposed order.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following way:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-1243 for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see section X of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background--Regulatory Authorities

    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 513(f)(3) 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)). Section 520(h)(4) of the FD&C Act provides 
that FDA may use, for reclassification of a device, certain information 
in a PMA 6 years after the application has been approved. This includes 
information from clinical and preclinical tests or studies that 
demonstrate the safety or effectiveness of the device but does not 
include descriptions of methods of manufacture or product composition 
and other trade secrets.
    Section 510(m) of the FD&C Act provides that a class II device may 
be exempted from the 510(k) premarket notification requirements, if the 
Agency determines that premarket notification is not necessary to 
assure the safety and effectiveness of the device.

II. Regulatory History of the Device and the Device Description

    A salivary stimulatory system is a postamendments device classified 
into class III under section 513(f)(1) of the FD&C Act. A salivary 
stimulatory system is an intraoral device intended to stimulate a 
relative increase in saliva production.

III. Proposed Reclassification and Summary of Reason for 
Reclassification

    FDA is proposing to reclassify these devices from class III into 
class II because sufficient information exists to establish special 
controls that can provide a reasonable assurance of the

[[Page 56028]]

device's safety and effectiveness. FDA believes that these special 
controls, together with general controls, will provide a reasonable 
assurance of safety and effectiveness.
    In accordance with section 513(f)(3) of the FD&C Act and 21 CFR 
part 860, subpart C, FDA is proposing to reclassify this postamendments 
class III device into class II (special controls). FDA believes that 
there is sufficient information available to FDA through FDA's 
accumulated experience with these devices from review submissions, 
knowledge of similar devices, peer-reviewed literature, and the 
manufacturer's petition to demonstrate that the proposed special 
controls can effectively mitigate the risks to health identified in the 
next section.
    FDA is proposing to identify the salivary stimulatory system under 
the new name of ``electrical salivary stimulator system'' to 
distinguish it from other devices that stimulate saliva flow via non-
electrical means. Under this proposed order, if finalized, the 
electrical salivary stimulatory system device will be 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. (Proposed 21 CFR 872.5560(a); 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.
    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 FDA a premarket notification prior to marketing the device.

IV. Risks to Health

    After considering the information available to FDA through review 
submissions, the manufacturer's petition, peer-reviewed literature, and 
knowledge of similar devices, FDA determined that the potential risks 
to health associated with the use of electrical salivary stimulatory 
systems are as follows:
     Hazards caused by electrical equipment--electrical 
salivary stimulatory systems have the potential to cause electrical 
shocks, thermal burns, and other hazards to a patient;
     hazards caused by electromagnetic interference and 
electrostatic discharge--electrical salivary stimulatory systems have 
the potential to cause electromagnetic interference or electrostatic 
discharge that can negatively affect the performance of the system or 
other electrical equipment in the vicinity of the system;
     damage to intraoral tissue or dentition--devices that 
malfunction or are poorly designed may damage intraoral tissue such as 
the gingiva or tongue or a patient's dentition; and
     adverse tissue reaction--devices with non-biocompatible 
materials may cause intraoral tissue infection, inflammation, 
irritation, or allergic reactions.

V. Summary of Data Upon Which the Reclassification Is Based

    FDA has considered and analyzed the following information: A search 
of the Agency's Manufacturer and User Facility Device Experience 
(MAUDE) database, which shows no adverse events for electrical salivary 
stimulatory systems; data contained in PMAs approved 6 or more years 
before the date of this proposal (reviewed under section 520(h)(4) of 
the FD&C Act, also known as the 6-year rule); and a review of 
transcutaneous electrical nerve stimulators, which are similar devices 
technologically, and are currently regulated as class II devices.

VI. Proposed Special Controls

    FDA tentatively concludes that the following special controls, 
together with general controls, are sufficient to mitigate the risks to 
health described in section IV:
     The design characteristics of the device must ensure that 
the geometry, material composition, and electrical output 
characteristics are consistent with the intended use;
     any element of the device that contacts the patient must 
be demonstrated to be biocompatible;
     appropriate analysis and/or testing must validate 
electromagnetic compatibility (EMC) and electrical safety, including 
the safety of any battery used in the device;
     software validation, verification, and hazard testing must 
be performed; and
     documented clinical experience must demonstrate safe and 
effective use for stimulating saliva production by addressing the risks 
of damage to intraoral tissue or dentition and of ineffective treatment 
and must capture any adverse events observed during clinical use.
    Table 1 demonstrates how these special controls will mitigate each 
risk to health described in section IV.

Table 1--Risks to Health and Mitigation Measures for Electrical Salivary
                            Stimulator System
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       Identified risk to health               Mitigation measures
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Hazards caused by electrical equipment.  Design characteristics.
                                         EMC and electrical safety
                                          analysis and/or testing
                                          Software validation,
                                          verification, and hazard
                                          testing.
                                         Documented clinical experience.
Hazards caused by electromagnetic        Design characteristics.
 interference and electrostatic          EMC and electrical safety
 discharge.                               analysis and/or testing.
Damage to intraoral tissue or dentition  Design characteristics.
                                         Documented clinical experience.
Adverse tissue reaction................  Biocompatibility.
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VII. 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.

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VIII. Paperwork Reduction Act of 1995

    This proposed 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 have been approved under OMB control number 0910-
0120.

IX. Proposed Effective Date

    FDA proposes that any final order based on this proposal become 
effective 30 days after the date of publication in the Federal 
Register.

X. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

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, it is proposed that 21 CFR part 872 be 
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 
geometry, 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: September 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22255 Filed 9-17-14; 8:45 am]
BILLING CODE 4164-01-P