83 FR 11144 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Over-the-Counter Denture Repair Kit
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 50 (March 14, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 50 (March 14, 2018)
| Page Range | 11144-11145 | |
| FR Document | 2018-05116 |
[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)] [Rules and Regulations] [Pages 11144-11145] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05116] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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] BILLING CODE 4164-01-P
![11144 Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Rules and Regulations
1. On page 8355, in the third column, introduction into interstate commerce Guidance@fda.hhs.gov to receive a copy
in the header of the document, the for commercial distribution of a device of the document. Please use the
docket number is corrected to read intended for human use to submit a document number 159 to identify the
‘‘FDA–2018–N–0399’’. 510(k) to FDA. The device may not be guidance you are requesting.
Dated: March 8, 2018. marketed until FDA finds it
III. Petition
‘‘substantially equivalent’’ within the
Leslie Kux,
meaning of section 513(i) of the FD&C On August 22, 2017, FDA received a
Associate Commissioner for Policy.
Act (21 U.S.C. 360c(i)) to a legally petition requesting an exemption from
[FR Doc. 2018–05115 Filed 3–13–18; 8:45 am] marketed device that does not require premarket notification for OTC denture
BILLING CODE 4164–01–P premarket approval. repair kits. (See Docket No. FDA–2017–
On November 21, 1997, the President P–5124.) These devices are currently
signed into law the Food and Drug classified under 21 CFR 872.3570, OTC
DEPARTMENT OF HEALTH AND Administration Modernization Act of denture repair kits.
HUMAN SERVICES 1997 (Pub. L. 105–115), section 206 of In the Federal Register of November
which added section 510(m) to the 20, 2017 (82 FR 55105), FDA published
Food and Drug Administration FD&C Act, as amended on December 13, a notice announcing that this petition
2016, by the 21st Century Cures Act had been received and provided
21 CFR Part 872 (Pub. L. 114–255). Section 510(m)(1) of opportunity for interested persons to
[Docket No. FDA–2017–P–5124] the FD&C Act, requires FDA to publish submit comments on the petition by
in the Federal Register a list of each January 19, 2018. FDA received no
Medical Devices; Exemption From type of class II device that does not comments.
Premarket Notification; Class II require a report under section 510(k) of
Devices; Over-the-Counter Denture FDA has assessed the need for 510(k)
the FD&C Act to provide reasonable
Repair Kit clearance for this type of device against
assurance of safety and effectiveness.
the criteria laid out in the Class II 510(k)
AGENCY: Food and Drug Administration, Section 510(m) of the FD&C Act further
Exemption Guidance. Based on this
HHS. provides that a 510(k) will no longer be
review, FDA believes that premarket
required for these devices upon the date
ACTION: Final order. notification is not necessary to provide
of publication of the list in the Federal
a reasonable assurance of the safety and
SUMMARY: The Food and Drug Register.
Section 510(m)(2) of the FD&C Act effectiveness of the device, as long as
Administration (FDA or Agency) is the device complies with existing
publishing an order granting a petition provides that FDA may exempt a device
from premarket notification special controls. FDA agrees that the
requesting exemption from premarket risks posed by the device and the
notification requirements for over-the- requirements on its own initiative, or
upon petition of an interested person, if characteristics of the device necessary
counter (OTC) denture repair kits for its safe and effective performance are
(Product Code EBO). These devices FDA determines that a 510(k) is not
necessary to provide assurance of the well established. FDA believes that
consist of material, such as a resin changes in the device that could affect
monomer system of powder and liquid safety and effectiveness of the device.
This section requires FDA to publish in safety and effectiveness will be readily
glues, which is intended to be applied detectable by certain types of routine
permanently to a denture to mend the Federal Register a notice of intent
to exempt a device, or of the petition, analysis and nonclinical testing, such as
cracks or breaks. This order exempts those detailed in the existing special
and to provide a 60-day comment
OTC denture repair kits, class II devices, controls. Therefore, after reviewing the
period. Within 120 days after the
from premarket notification (510(k)). petition, FDA has determined that
issuance of the notice, FDA shall
This exemption from 510(k) is premarket notification is not necessary
publish an order in the Federal Register
immediately in effect for OTC denture to provide a reasonable assurance of
setting forth the final determination
repair kits. FDA is publishing this order safety and effectiveness of OTC denture
regarding the exemption of the device
in accordance with the section of the repair kits. FDA responded to the
that was the subject of the notice. If FDA
Federal Food, Drug, and Cosmetic Act petition by letter dated January 31,
fails to respond to a petition under this
(FD&C Act) permitting the exemption of 2018, to inform the petitioner of this
section within 180 days of receiving it,
a device from the requirement to submit decision within the 180-day timeframe
the petition shall be deemed granted.
a 510(k). under section 510(m)(2) of the FD&C
DATES: This order is effective March 14, II. Criteria for Exemption Act.
2018. The exemption was applicable on There are a number of factors FDA
January 31, 2018. IV. Limitations of Exemption
may consider to determine whether a
FOR FURTHER INFORMATION CONTACT: 510(k) is necessary to provide This final order exempts from
Rebecca Nipper, Center for Devices and reasonable assurance of the safety and premarket notification an OTC denture
Radiological Health (CDRH), Food and effectiveness of a class II device. These repair kit. This device will remain
Drug Administration, 10903 New factors are discussed in the guidance subject to the class II special controls
Hampshire Ave., Bldg. 66, Rm. 1540, that the Agency issued on February 19, under 21 CFR 872.3570 and will be
Silver Spring, MD 20993–0002, 301– 1998, entitled ‘‘Procedures for Class II subject to the limitations of exemption
796–6527. Device Exemptions from Premarket found in 21 CFR 872.9.
SUPPLEMENTARY INFORMATION: Notification, Guidance for Industry and
V. Analysis of Environmental Impact
CDRH Staff’’ (Class II 510(k) Exemption
daltland on DSKBBV9HB2PROD with RULES
I. Statutory Background Guidance). That guidance can be The Agency has determined under 21
Section 510(k) of the FD&C Act (21 obtained through the internet at https:// CFR 25.30(h) that this action is of a type
U.S.C. 360(k)) and its implementing www.fda.gov/downloads/Medical that does not individually or
regulations in part 807 (21 CFR part Devices/DeviceRegulationandGuidance/ cumulatively have a significant effect on
807) require persons who propose to GuidanceDocuments/UCM080199.pdf the human environment. Therefore,
begin the introduction or delivery for or by sending an email request to CDRH- neither an environmental assessment
VerDate Sep<11>2014 16:14 Mar 13, 2018 Jkt 244001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\14MRR1.SGM 14MRR1](https://thefederalregister.org/doc/83_FR_11194/page/1.svg)
![Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Rules and Regulations 11145
nor an environmental impact statement NATIONAL ARCHIVES AND RECORDS documents. We notify customers if we
is required. ADMINISTRATION anticipate the reproduction will have
questionable legibility and request the
VI. Paperwork Reduction Act of 1995 36 CFR Part 1258 customer’s approval to proceed with the
This final order refers to previously [FDMS No. NARA–18–0001; NARA–2018– reproduction—and the fee charges. As a
approved collections of information 019] result, we do not provide refunds except
found in other FDA regulations and in special cases; primarily if we have
guidance. These collections of RIN 3095–AB96 somehow processed an order incorrectly
information are subject to review by the or it contains errors. However, the
Office of Management and Budget Fees
regulation’s refund request period is of
(OMB) under the Paperwork Reduction AGENCY: National Archives and Records such a length (120 days) that the NATF
Act of 1995 (44 U.S.C. 3501–3520). The Administration (NARA). has been receiving a significant number
collections of information in part 807, ACTION: Direct final rule. of refund requests for orders that
subpart E, regarding premarket contain no errors and were processed
notification submissions, have been SUMMARY: NARA is amending our Fees correctly, which is causing the NATF
approved under OMB control number regulation to shorten the period in administrative processing burdens. As a
0910–0120. which people who request copies of result, we are now reducing the refund
archival records may request a refund. request period to 30 days, which we
List of Subjects in 21 CFR Part 872 This shorter period is in line with other believe will reduce the number of these
Medical devices. similar research and archival other types of refund requests. A 30-day
Therefore, under the Federal Food, institutions and is designed to reduce refund period is also in line with similar
Drug, and Cosmetic Act and under the administrative costs of processing a deadlines at other research and archival
authority delegated to the Commissioner large number of refund requests that fall institutions that allow refund requests,
of Food and Drugs, 21 CFR part 872 is outside the permitted bases. such as the Library of Congress. Many
amended as follows: DATES: This rule is effective on April 13, such organizations do not permit
2018 without further notice, unless we refunds at all (e.g., USCIS Genealogy
PART 872—DENTAL DEVICES receive adverse written comment that Program). We would like to continue
warrants revision by April 3, 2018. If we permitting refunds when there has been
■ 1. The authority citation for part 872 receive such comments, we will publish an error, but we believe the shorter
is revised to read as follows: a timely withdrawal of the direct final period will still provide sufficient time
Authority: 21 U.S.C. 351, 360, 360c, 360e, rule in the Federal Register. in which to request a refund while
360j, 360l, 371. ADDRESSES: You may submit comments, reducing the inappropriate refund
■ 2. In § 872.3570, revise paragraph (b) identified by RIN 3095–AB95, by email requests and NARA’s administrative
introductory text to read as follows: at regulation_comments@nara.gov, or by costs.
mail to the External Policy Program Regulatory Review Information
§ 872.3570 OTC denture repair kit.
Manager; Strategy Division (MP), Suite
* * * * * 4100; National Archives and Records This rule is not a significant
(b) Classification. Class II. The OTC Administration; 8601 Adelphi Road; regulatory action for the purposes of
denture repair kit is exempt from College Park, MD 20740–6001. E.O. 12866 and a significance
premarket notification procedures in determination was requested from the
FOR FURTHER INFORMATION CONTACT:
subpart E of part 807 of this chapter, Office of Management and Budget
Kimberly Keravuori, by email at
subject to § 872.9. The special controls (OMB). It is also not a major rule as
regulation_comments@nara.gov, or by
for this device are FDA’s: defined in 5 U.S.C. Chapter 8,
telephone at 301–837–3151.
* * * * * Congressional Review of Agency
SUPPLEMENTARY INFORMATION:
Dated: March 8, 2018. Rulemaking. As a result, this rule is also
Leslie Kux,
Background not subject to deregulatory requirements
NARA is authorized by 44 U.S.C. contained in E.O. 13771. As required by
Associate Commissioner for Policy.
2116(c) to charge reproduction fees the Regulatory Flexibility Act, we
[FR Doc. 2018–05116 Filed 3–13–18; 8:45 am]
when it reproduces documents for non- certify that this rule will not have a
BILLING CODE 4164–01–P
Federal individuals or entities. This significant impact on a substantial
includes official reproductions with the number of small entities; it simply
Archives’ seal, reproductions of shortens the period in which people
DEPARTMENT OF HOMELAND archival holdings, and reproductions of may request refunds of reproduction
SECURITY operational records. The statute fees. This rule also does not have any
authorizes NARA to recoup its costs, Federalism implications.
Coast Guard equipment fees, and similar expenses, This rule is effective upon publication
and to retain the fees as part of the for good cause as permitted by the
33 CFR Part 117 National Archives Trust Fund (NATF). Administrative Procedure Act (5 U.S.C.
NARA promulgated regulations at 36 553(d)(3)). NARA believes that a public
Drawbridge Operations Regulations
CFR part 1258 to notify users of the fee comment period is unnecessary as this
CFR Correction structure and processes. Among these rule merely shortens the recently added
refund request period to bring it in line
daltland on DSKBBV9HB2PROD with RULES
regulations is a section addressing
■ In Title 33 of the Code of Federal refunds of these fees (36 CFR 1258.16). with similar periods at other research
Regulations, Parts 1 to 124, revised as of It is this provision that we are revising and archival institutions, such as the
July 1, 2017, on page 646, in § 117.739, with this rulemaking. Library of Congress.
paragraph (o) is removed and reserved. Due to various factors, it is
List of Subjects in 36 CFR Part 1258
[FR Doc. 2018–05245 Filed 3–13–18; 8:45 am] occasionally difficult for us to make a
BILLING CODE 1301–00–D legible reproduction, particularly of old Archives and records.
VerDate Sep<11>2014 16:14 Mar 13, 2018 Jkt 244001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\14MRR1.SGM 14MRR1](https://thefederalregister.org/doc/83_FR_11194/page/2.svg)
Document Created: 2018-03-14 01:06:32
Document Modified: 2018-03-14 01:06:32
| 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 March 14, 2018. The exemption was applicable on January 31, 2018. | |
| 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. | |
| FR Citation | 83 FR 11144 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR