[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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