[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Rules and Regulations]
[Pages 11144-11145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05116]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. FDA-2017-P-5124]


Medical Devices; Exemption From Premarket Notification; Class II 
Devices; Over-the-Counter Denture Repair Kit

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing 
an order granting a petition requesting exemption from premarket 
notification requirements for over-the-counter (OTC) denture repair 
kits (Product Code EBO). These devices consist of material, such as a 
resin monomer system of powder and liquid glues, which is intended to 
be applied permanently to a denture to mend cracks or breaks. This 
order exempts OTC denture repair kits, class II devices, from premarket 
notification (510(k)). This exemption from 510(k) is immediately in 
effect for OTC denture repair kits. FDA is publishing this order in 
accordance with the section of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) permitting the exemption of a device from the requirement to 
submit a 510(k).

DATES: This order is effective March 14, 2018. The exemption was 
applicable on January 31, 2018.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-
796-6527.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and its 
implementing regulations in part 807 (21 CFR part 807) require persons 
who propose to begin the introduction or delivery for introduction into 
interstate commerce for commercial distribution of a device intended 
for human use to submit a 510(k) to FDA. The device may not be marketed 
until FDA finds it ``substantially equivalent'' within the meaning of 
section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a legally 
marketed device that does not require premarket approval.
    On November 21, 1997, the President signed into law the Food and 
Drug Administration Modernization Act of 1997 (Pub. L. 105-115), 
section 206 of which added section 510(m) to the FD&C Act, as amended 
on December 13, 2016, by the 21st Century Cures Act (Pub. L. 114-255). 
Section 510(m)(1) of the FD&C Act, requires FDA to publish in the 
Federal Register a list of each type of class II device that does not 
require a report under section 510(k) of the FD&C Act to provide 
reasonable assurance of safety and effectiveness. Section 510(m) of the 
FD&C Act further provides that a 510(k) will no longer be required for 
these devices upon the date of publication of the list in the Federal 
Register.
    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a 
device from premarket notification requirements on its own initiative, 
or upon petition of an interested person, if FDA determines that a 
510(k) is not necessary to provide assurance of the safety and 
effectiveness of the device. This section requires FDA to publish in 
the Federal Register a notice of intent to exempt a device, or of the 
petition, and to provide a 60-day comment period. Within 120 days after 
the issuance of the notice, FDA shall publish an order in the Federal 
Register setting forth the final determination regarding the exemption 
of the device that was the subject of the notice. If FDA fails to 
respond to a petition under this section within 180 days of receiving 
it, the petition shall be deemed granted.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether 
a 510(k) is necessary to provide reasonable assurance of the safety and 
effectiveness of a class II device. These factors are discussed in the 
guidance that the Agency issued on February 19, 1998, entitled 
``Procedures for Class II Device Exemptions from Premarket 
Notification, Guidance for Industry and CDRH Staff'' (Class II 510(k) 
Exemption Guidance). That guidance can be obtained through the internet 
at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf or by 
sending an email request to [email protected] to receive a copy 
of the document. Please use the document number 159 to identify the 
guidance you are requesting.

III. Petition

    On August 22, 2017, FDA received a petition requesting an exemption 
from premarket notification for OTC denture repair kits. (See Docket 
No. FDA-2017-P-5124.) These devices are currently classified under 21 
CFR 872.3570, OTC denture repair kits.
    In the Federal Register of November 20, 2017 (82 FR 55105), FDA 
published a notice announcing that this petition had been received and 
provided opportunity for interested persons to submit comments on the 
petition by January 19, 2018. FDA received no comments.
    FDA has assessed the need for 510(k) clearance for this type of 
device against the criteria laid out in the Class II 510(k) Exemption 
Guidance. Based on this review, FDA believes that premarket 
notification is not necessary to provide a reasonable assurance of the 
safety and effectiveness of the device, as long as the device complies 
with existing special controls. FDA agrees that the risks posed by the 
device and the characteristics of the device necessary for its safe and 
effective performance are well established. FDA believes that changes 
in the device that could affect safety and effectiveness will be 
readily detectable by certain types of routine analysis and nonclinical 
testing, such as those detailed in the existing special controls. 
Therefore, after reviewing the petition, FDA has determined that 
premarket notification is not necessary to provide a reasonable 
assurance of safety and effectiveness of OTC denture repair kits. FDA 
responded to the petition by letter dated January 31, 2018, to inform 
the petitioner of this decision within the 180-day timeframe under 
section 510(m)(2) of the FD&C Act.

IV. Limitations of Exemption

    This final order exempts from premarket notification an OTC denture 
repair kit. This device will remain subject to the class II special 
controls under 21 CFR 872.3570 and will be subject to the limitations 
of exemption found in 21 CFR 872.9.

V. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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

[[Page 11145]]

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 other FDA regulations and guidance. 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.

List of Subjects in 21 CFR Part 872

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
872 is amended as follows:

PART 872--DENTAL DEVICES

0
1. The authority citation for part 872 is revised to read as follows:

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

0
2. In Sec.  872.3570, revise paragraph (b) introductory text to read as 
follows:


Sec.  872.3570  OTC denture repair kit.

* * * * *
    (b) Classification. Class II. The OTC denture repair kit is exempt 
from premarket notification procedures in subpart E of part 807 of this 
chapter, subject to Sec.  872.9. The special controls for this device 
are FDA's:
* * * * *

    Dated: March 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05116 Filed 3-13-18; 8:45 am]
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