Medical Devices; Technical Amendment, 12083 [2019-06139]
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Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Rules and Regulations
12083
CAUTION: Contains lead acetate. For external use only. Keep this product out of children’s reach. Do not use on cut or abraded scalp. If
skin irritation develops, discontinue use. Do not use to color mustaches, eyelashes, eyebrows, or hair on parts of the body other than the
scalp. Do not get in eyes. Follow instructions carefully and wash hands thoroughly after each use.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
provides only technical changes to
correct inaccurate cross-references.
In the Federal Register of September
24, 2013 (78 FR 58821), FDA added the
definition of ‘‘Human cells, tissues, or
cellular or tissue-based product (HCT/P)
regulated as a device’’ at § 806.2(f). The
addition of this definition caused the
paragraphs following paragraph (f) in
§ 806.2 to be redesignated
alphabetically. Although the definitions
of the terms were correct in § 806.2, the
paragraphs in § 806.1(b) crossreferenced three of the definitions
(market withdrawal, routine servicing,
and stock recovery) from § 806.2 based
on the previous designations.
Food and Drug Administration
List of Subjects in 21 CFR Part 806
21 CFR Part 806
Imports; Medical devices; Reporting
and recordkeeping requirements.
[Docket No. FDA–2019–N–1345]
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 806 is
amended as follows:
(e) Exemption for certification.
Certification of this color additive for
the prescribed use is not necessary for
the protection of the public health and
therefore batches thereof are exempt
from the certification requirements of
section 721(c) of the Federal Food, Drug,
and Cosmetic Act.
Dated: March 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06238 Filed 3–29–19; 8:45 am]
BILLING CODE 4164–01–P
Medical Devices; Technical
Amendment
AGENCY:
Food and Drug Administration;
HHS.
PART 806—MEDICAL DEVICES;
REPORTS OF CORRECTIONS AND
REMOVALS
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
amending the medical device reports of
corrections and removals regulation to
correct three inaccurate crossreferences. This action is editorial in
nature and is intended to improve the
accuracy of the Agency’s regulations.
DATES: This rule is effective April 1,
2019.
SUMMARY:
Madhusoodana Nambiar, Office of the
Center Director, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5518, Silver Spring,
MD 20993–0002, 301–796–5837.
SUPPLEMENTARY INFORMATION: FDA is
amending 21 CFR 806.1 to correct three
inaccurate cross-references to ensure
accuracy and clarity in the Agency’s
medical device regulations regarding
medical device reports of corrections
and removals. Publication of this
document constitutes final action under
the Administrative Procedure Act (5
U.S.C. 553). FDA has determined that
notice and public comment are
unnecessary because this amendment to
the regulation is nonsubstantive and
15:56 Mar 29, 2019
Jkt 247001
Authority: 21 U.S.C. 352, 360, 360i, 360j,
371, 374.
2. In § 806.1, revise paragraphs (b)(2)
through (4) to read as follows:
■
§ 806.1
Scope.
*
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
1. The authority citation for part 806
continues to read as follows:
■
*
*
*
*
(b) * * *
(2) Market withdrawal as defined in
§ 806.2(i)
(3) Routine servicing as defined in
§ 806.2(l).
(4) Stock recovery as defined in
§ 806.2(m).
Dated: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06139 Filed 3–29–19; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2011–N–0103]
RIN 0910–AH98
Microbiology Devices; Classification of
In Vitro Diagnostic Devices for Bacillus
Species Detection
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA, the Agency, or
we) is issuing a final rule to classify in
vitro diagnostic devices for Bacillus
species (spp.) detection into class II
(special controls) and to continue to
require a premarket notification (510(k))
to provide a reasonable assurance of
safety and effectiveness of the device.
FDA is also establishing special controls
in a special controls guideline in
addition to restricting use and
distribution of the devices. An in vitro
diagnostic device for Bacillus spp.
detection is a prescription device used
to detect and differentiate among
Bacillus spp. and presumptively
identify B. anthracis and other Bacillus
spp. from cultured isolates or clinical
specimens as an aid in the diagnosis of
anthrax and other diseases caused by
Bacillus spp.
DATES: This rule is effective May 1,
2019. See further discussion in section
V ‘‘Implementation Strategy’’.
ADDRESSES: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number found in brackets in the
heading of this final rule into the
‘‘Search’’ box and follow the prompts,
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beena Puri, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4502, Silver Spring,
MD 20993–0002, 301–796–6202.
Beena.Puri@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Table of Contents
I. Executive Summary
Frm 00037
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01APR1
]]>Agencies
[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Rules and Regulations]
[Page 12083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06139]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 806
[Docket No. FDA-2019-N-1345]
Medical Devices; Technical Amendment
AGENCY: Food and Drug Administration; HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is amending
the medical device reports of corrections and removals regulation to
correct three inaccurate cross-references. This action is editorial in
nature and is intended to improve the accuracy of the Agency's
regulations.
DATES: This rule is effective April 1, 2019.
FOR FURTHER INFORMATION CONTACT: Madhusoodana Nambiar, Office of the
Center Director, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5518,
Silver Spring, MD 20993-0002, 301-796-5837.
SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR 806.1 to correct
three inaccurate cross-references to ensure accuracy and clarity in the
Agency's medical device regulations regarding medical device reports of
corrections and removals. Publication of this document constitutes
final action under the Administrative Procedure Act (5 U.S.C. 553). FDA
has determined that notice and public comment are unnecessary because
this amendment to the regulation is nonsubstantive and provides only
technical changes to correct inaccurate cross-references.
In the Federal Register of September 24, 2013 (78 FR 58821), FDA
added the definition of ``Human cells, tissues, or cellular or tissue-
based product (HCT/P) regulated as a device'' at Sec. 806.2(f). The
addition of this definition caused the paragraphs following paragraph
(f) in Sec. 806.2 to be redesignated alphabetically. Although the
definitions of the terms were correct in Sec. 806.2, the paragraphs in
Sec. 806.1(b) cross-referenced three of the definitions (market
withdrawal, routine servicing, and stock recovery) from Sec. 806.2
based on the previous designations.
List of Subjects in 21 CFR Part 806
Imports; Medical devices; Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
806 is amended as follows:
PART 806--MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
0
1. The authority citation for part 806 continues to read as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
0
2. In Sec. 806.1, revise paragraphs (b)(2) through (4) to read as
follows:
Sec. 806.1 Scope.
* * * * *
(b) * * *
(2) Market withdrawal as defined in Sec. 806.2(i)
(3) Routine servicing as defined in Sec. 806.2(l).
(4) Stock recovery as defined in Sec. 806.2(m).
Dated: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06139 Filed 3-29-19; 8:45 am]
BILLING CODE 4164-01-P
