80 FR 72585 - Dental Devices; Reclassification of Electrical Salivary Stimulator System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 224 (November 20, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 224 (November 20, 2015)
| Page Range | 72585-72586 | |
| FR Document | 2015-29638 |
[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)] [Rules and Regulations] [Pages 72585-72586] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29638] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Rules and Regulations 72585
§ 150.141 [Removed] 513(f)(1) of the FD&C Act into class III On September 18, 2014, FDA
■ 2. Remove § 150.141. without any FDA rulemaking process. published an order in the Federal
Those devices remain in class III and Register to reclassify the device (79 FR
§ 150.161 [Removed] require premarket approval unless, and 56027) (the ‘‘proposed order’’). The
■ 3. Remove § 150.161. until, the device is reclassified into class period for public comment on the
I or II, or FDA issues an order finding proposed order closed on December 17,
Dated: November 16, 2015.
the device to be substantially 2014. FDA received and has considered
Leslie Kux, 20 comments on the proposed order, as
equivalent, in accordance with section
Associate Commissioner for Policy. 513(i) of the FD&C Act, to a predicate discussed in section II.
[FR Doc. 2015–29631 Filed 11–19–15; 8:45 am] device that does not require premarket II. Public Comments in Response to the
BILLING CODE 4164–01–P approval. The Agency determines Proposed Order
whether new devices are substantially
equivalent to predicate devices by Of the 20 public comments that FDA
DEPARTMENT OF HEALTH AND means of premarket notification received in response to the proposed
HUMAN SERVICES procedures in section 510(k) of the order, 17 comments supported the
FD&C Act (21 U.S.C. 360(k)) and part proposed reclassification and 3
Food and Drug Administration comments were opposed. All of the
807 (21 CFR part 807).
A postamendments device that has commenters were individuals, 12 of
21 CFR Part 872 whom identified themselves as medical
been initially classified in class III
[Docket No. FDA–2014–N–1243] under section 513(f)(1) of the FD&C Act practitioners. Eight of these 12
may be reclassified into class I or class practitioners claimed prior research
Dental Devices; Reclassification of II under section 513(f)(3) of the FD&C experience with the device. Three
Electrical Salivary Stimulator System Act. Section 513(f)(3) provides that FDA commenters claimed experience with
acting by order can reclassify the device the device as patients in clinical trials.
AGENCY: Food and Drug Administration, All of the practitioners’ and patients’
HHS. into class I or class II on its own
comments were supportive of the
ACTION: Final order. initiative, or in response to a petition
reclassification proposal. All of the
from the manufacturer or importer of
practitioners with prior experience
SUMMARY: The Food and Drug the device. To change the classification
administering the device noted
Administration (FDA) is issuing a final of the device, the proposed new class
favorable results for some of their
order to reclassify the salivary must have sufficient regulatory controls
patients and no adverse events. The
stimulator system, a postamendments to provide reasonable assurance of the
other four practitioners who commented
Class III device, into class II (special safety and effectiveness of the device for
either had recommended, or if available
controls) and to rename the device the its intended use.
would recommend, the device as a non-
‘‘electrical salivary stimulator system.’’ Reevaluation of the data previously
pharmaceutical option for treating dry
The Agency is classifying the device before the Agency is an appropriate
mouth conditions.
into class II (special controls) in order basis for subsequent action where the Five commenters did not claim any
to provide a reasonable assurance of reevaluation is made in light of newly prior professional or patient experience
safety and effectiveness of the device. available regulatory authority (see Bell with the device. Of these comments,
DATES: This order is effective December v. Goddard, 366 F.2d 177, 181 (7th Cir. two favored finalization of the proposed
21, 2015. 1966); Ethicon, Inc. v. FDA, 762 F. reclassification based on the evidence
FOR FURTHER INFORMATION CONTACT: Supp. 382, 388–391 (D.D.C. 1991)), or in presented in the proposed order.
Michael Ryan, Center for Devices and light of changes in ‘‘medical science’’ Three comments opposed the
Radiological Health, Food and Drug (Upjohn v. Finch, 422 F.2d 944, 951 (6th proposed reclassification. None of these
Administration, 10903 New Hampshire Cir. 1970)). Whether data before the commenters claimed prior professional
Ave., Bldg. 66, Rm. 1615, Silver Spring, Agency are old or new, the ‘‘new or patient experience with the device.
MD 20993, 301–796–6283. information’’ to support reclassification One commenter believed that the
SUPPLEMENTARY INFORMATION: under section 513(f)(3) of the FD&C Act proposed order adequately addressed
must be ‘‘valid scientific evidence’’, as safety concerns but failed to provide
I. Background defined in section 513(a)(3) and 21 CFR convincing evidence of the effectiveness
The Federal Food, Drug, and Cosmetic 860.7(c)(2). (See, e.g., General Medical of the device.
Act (the FD&C Act), as amended, 21 Co. v. FDA, 770 F.2d 214 (D.C. Cir. FDA disagrees with the comment. The
U.S.C. 301 et seq., establishes a 1985); Contact Lens Mfrs. Assoc. v. FDA, special control requiring documented
comprehensive system for the regulation 766 F.2d 592 (D.C. Cir.1985), cert. clinical experience will allow the
of medical devices intended for human denied, 474 U.S. 1062 (1986)). Agency to require information on each
use. Section 513 of the FD&C Act (21 FDA relies upon ‘‘valid scientific device’s effectiveness in actual clinical
U.S.C. 360c) established three categories evidence’’ in the classification process use.
(classes) of devices, reflecting the to determine the level of regulation for Two commenters believed that the
regulatory controls needed to provide devices. To be considered in the devices should undergo further clinical
reasonable assurance of their safety and reclassification process, the ‘‘valid trials to evaluate device and human
effectiveness. The three categories of scientific evidence’’ upon which the factors risks, and that electrically
devices are class I (general controls), Agency relies must be publicly powered salivary stimulators are
class II (special controls), and class III available. Publicly available information inherently hazardous and subject to
tkelley on DSK3SPTVN1PROD with RULES
(premarket approval). excludes trade secret and/or misuse and, without conclusive test
Devices that were not in commercial confidential commercial information, results, should continue to be classified
distribution prior to May 28, 1976 e.g., the contents of a pending premarket as Class III devices and be subject to
(generally referred to as approval application (PMA) (see section premarket approval.
postamendments devices) are 520(c) of the FD&C Act (21 U.S.C. The Agency disagrees that electrical
automatically classified by section 360j(c)). salivary stimulator systems should
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![72586 Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Rules and Regulations
remain class III and subject to premarket The device is assigned the generic List of Subjects in 21 CFR Part 872
approval. The Agency believes that the name electrical salivary stimulator
special controls required in this final system, and it is identified as a Medical devices.
order provide a reasonable assurance of prescription intraoral device intended to Therefore, under the Federal Food,
safety and effectiveness for these electrically stimulate a relative increase Drug, and Cosmetic Act (21 U.S.C. 321
devices. FDA believes it has identified in saliva production. FDA is identifying et seq., as amended) and under
the risks to health (see section VI of the the device under this new name to authority delegated to the Commissioner
proposed order) and that the mitigation distinguish it from other devices that
of Food and Drugs, 21 CFR part 872 is
measures described in the final order stimulate saliva flow via non-electrical
amended as follows:
will be effective in mitigating the risks means.
described in the two comments, Under this final order, the electrical
PART 872—DENTAL DEVICES
including the risks associated with the salivary stimulatory system device is a
low-voltage electrical features of the prescription device restricted to patient
devices. In particular, the special use only upon the authorization of a ■ 1. The authority citation for 21 CFR
control requiring documented clinical dental practitioner or physician licensed part 872 continues to read as follows:
experience will allow the Agency to by law to administer or use the device
require information on each device’s (see 21 CFR 801.109 (Prescription Authority: 21 U.S.C. 351, 360, 360c, 360e,
safety and effectiveness in actual devices)). Prescription-use restrictions 360j, 371.
clinical use, including any human are a type of general control defined in
factors risks. These devices utilize section 513(a)(1)(A)(i) of the FD&C Act. ■ 2. Add § 872.5560 to subpart F to read
technology similar to that used in other The labeling of the device must bear all as follows:
class II medical devices such as information required for the safe and
transcutaneous electrical nerve effective use of prescription devices as § 872.5560 Electrical salivary stimulatory
stimulators. The Agency believes that its outlined in § 801.109. system.
experience with similar devices and the Under section 513(f)(3) of the FD&C (a) Identification. An electrical
lack of adverse events for salivary Act, FDA is adopting its findings as
salivary stimulatory system is a
stimulators in FDA’s Manufacturer and published in the preamble to the
prescription intraoral device that is
User Facility Device Experience proposed order, with the following
correction: FDA stated in the proposed intended to electrically stimulate a
(MAUDE) database and peer-reviewed
order that the Agency utilized section relative increase in saliva production.
literature provide sufficient information
to establish special controls that 520(h)(4) of the FD&C Act to review data (b) Classification—Class II (special
mitigated the risks to health identified contained in premarket approval controls). The special controls for this
for this device type in the proposed applications (PMAs) approved 6 or more device are:
order. years before the date of the proposed (1) The design characteristics of the
The Agency is making a minor order. The Agency would like to clarify device must ensure that the device
modification to the proposed special that this language was included design, material composition, and
controls for electrical salivary stimulator unintentionally, and that the provisions
electrical output characteristics are
systems by replacing the term of section 520(h)(4) were not utilized in
‘‘geometry’’ in the first special control consistent with the intended use;
this rulemaking proceeding.
with the term ‘‘device design.’’ FDA (2) Any element of the device that
IV. Environmental Impact, No contacts the patient must be
makes this revision to clarify the intent
of the special control. Significant Impact demonstrated to be biocompatible;
We have determined under 21 CFR (3) Appropriate analysis and/or
III. The Final Order 25.34(b) that this action is of a type that
testing must validate electromagnetic
Under section 513(f)(3) of the FD&C does not individually or cumulatively
Act, FDA is adopting its findings as compatibility and electrical safety,
have a significant effect on the human
published in the preamble to the environment. Therefore, neither an including the safety of any battery used
proposed order. FDA is issuing this final environmental assessment nor an in the device;
order to reclassify salivary stimulator environmental impact statement is (4) Software validation, verification,
system devices from class III to class II, required. and hazard testing must be performed;
rename them electrical salivary and
stimulator systems, and establish V. Paperwork Reduction Act of 1995
(5) Documented clinical experience
special controls by revising part 872 (21 This final administrative order
establishes special controls that refer to must demonstrate safe and effective use
CFR part 872).
Section 510(m) of the FD&C Act previously approved collections of for stimulating saliva production by
provides that FDA may exempt a class information found in other FDA addressing the risks of damage to
II device from the premarket notification regulations. These collections of intraoral tissue and of ineffective
requirements under section 510(k) of the information are subject to review by the treatment and must capture any adverse
FD&C Act if FDA determines that Office of Management and Budget events observed during clinical use.
premarket notification is not necessary (OMB) under the Paperwork Reduction Dated: November 13, 2015.
to provide reasonable assurance of the Act of 1995 (44 U.S.C. 3501–3520). The Leslie Kux,
safety and effectiveness of the devices. collections of information in part 807,
Associate Commissioner for Policy.
FDA has determined that premarket subpart E, regarding premarket
tkelley on DSK3SPTVN1PROD with RULES
[FR Doc. 2015–29638 Filed 11–19–15; 8:45 am]
notification is necessary to provide notification submissions have been
reasonable assurance of safety and approved under OMB control number BILLING CODE 4164–01–P
effectiveness of electrical salivary 0910–0120, and the collections of
stimulator systems, and therefore, this information in 21 CFR part 801,
device type is not exempt from regarding labeling, have been approved
premarket notification requirements. under OMB control number 0910–0485.
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Document Created: 2015-12-14 13:59:10
Document Modified: 2015-12-14 13:59:10
| 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 December 21, 2015. | |
| 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. | |
| FR Citation | 80 FR 72585 |
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