Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss, 50080 [2017-23490]
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Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations
of TREC levels and include samples
within the measuring range, samples
above and below the measuring range,
and samples very near above and below
the cutoff value. Multiple punches must
be obtained from each card for
demonstration of homogeneity of the
analyte across the dried blood spot.
Comparability of the test performance
for each filter paper must be
demonstrated. Stability and storage of
TREC DNA on each blood spot card
must be demonstrated. Results of the
lot-to-lot study must be summarized
providing the mean, standard deviation,
and percentage coefficient of variation
in a tabular format. Data must be
calculated for within-run, between-run,
within-lot, and between-lot. Data
demonstrating the concordance between
results across different filter papers
must be provided. Study acceptance
criteria must be provided and followed;
and
(I) If applicable, a thermocycler
reproducibility study must be
performed using thermocyclers from
three independent thermocyler
manufacturers. The sample panel must
consist of specimens with a range of
TREC levels and must include samples
within the measuring range, samples
above and below the measuring range,
and samples very near above and below
the cutoff value. The study must be
done using three filter paper lots and
conducted over five nonconsecutive
days. Results of the thermocycler
reproducibility study must be
summarized providing the mean,
standard deviation, and percentage
coefficient of variance in a tabular
format. Data must be calculated for the
within-run, between-run, within-lot,
between-lot, and between thermocycler
manufacturer study results. Study
acceptance criteria must be provided
and followed.
(iv) Identification of risk mitigation
elements used by your device, including
a description of all additional
procedures, methods, and practices
incorporated into the directions for use
that mitigate risks associated with
testing.
(2) Your § 809.10 compliant labeling
must include:
(i) A warning statement that reads
‘‘This test is not intended for diagnostic
use, preimplantation or prenatal testing,
or for screening of SCID-like syndromes,
such as DiGeorge syndrome or Omenn
syndrome. It is also not intended to
screen for less acute SCID syndromes,
such as leaky SCID or variant SCID.’’;
(ii) A warning statement that reads
‘‘Test results are intended to be used in
conjunction with other clinical and
diagnostic findings, consistent with
VerDate Sep<11>2014
13:41 Oct 27, 2017
Jkt 244001
professional standards of practice,
including confirmation by alternative
methods and clinical evaluation, as
appropriate.’’;
(iii) A description of the performance
studies listed in paragraph (b)(1)(iii) and
a summary of the results; and
(iv) A description of the filter paper
specifications required for the test.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23496 Filed 10–27–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA–2017–N–1609]
Medical Devices; GastroenterologyUrology Devices; Classification of the
Oral Removable Palatal Space
Occupying Device for Weight
Management and/or Weight Loss
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order; correction.
The Food and Drug
Administration (FDA) is correcting a
final order entitled ‘‘Medical Devices;
Gastroenterology-Urology Devices;
Classification of the Oral Removable
Palatal Space Occupying Device for
Weight Management and/or Weight
Loss’’ that appeared in the Federal
Register of July 28, 2017. The final order
was published with an incorrect
statement in the preamble about
whether FDA planned to exempt the
device from premarket notification
requirements. This document corrects
that error.
DATES: Effective October 30, 2017
FOR FURTHER INFORMATION CONTACT:
Mark Antonino, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G208, Silver Spring,
MD 20993–0002, 240–402–9980,
mark.antonino@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of July 28, 2017 (82 FR
35067), FDA published the final order
‘‘Medical Devices; GastroenterologyUrology Devices; Classification of the
Oral Removable Palatal Space
Occupying Device for Weight
Management and/or Weight Loss.’’ The
final order published with an incorrect
statement in the preamble about
SUMMARY:
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
whether FDA planned to exempt the
device from premarket notification
requirements under section 510(k) of the
FD&C Act.
In the Federal Register of July 28,
2017, (82 FR 35067), the following
correction is made: On page 35069, in
the first column, the first paragraph is
corrected as follows:
‘‘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), if
FDA determines that premarket
notification is not necessary to provide
reasonable assurance of the safety and
effectiveness of the device. For this type
of device, FDA has determined that
premarket notification is necessary to
provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, this device type is not
exempt from premarket notification
requirements. Persons who intend to
market this type of device must submit
to FDA a premarket notification, prior to
marketing the device, which contains
information about the oral removable
palatal space occupying device for
weight management and/or weight loss
they intend to market.’’
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23490 Filed 10–27–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA–2017–N–5934]
Medical Devices; Neurological
Devices; Classification of the NonElectroencephalogram Physiological
Signal Based Seizure Monitoring
System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the nonelectroencephalogram (non-EEG)
physiological signal based seizure
monitoring system into class II (special
controls). The special controls that
apply to the device type are identified
in this order and will be part of the
codified language for the non-EEG
physiological signal based seizure
monitoring system’s classification. We
SUMMARY:
E:\FR\FM\30OCR1.SGM
30OCR1
]]>Agencies
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Page 50080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23490]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2017-N-1609]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Oral Removable Palatal Space Occupying Device for Weight
Management and/or Weight Loss
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a final
order entitled ``Medical Devices; Gastroenterology-Urology Devices;
Classification of the Oral Removable Palatal Space Occupying Device for
Weight Management and/or Weight Loss'' that appeared in the Federal
Register of July 28, 2017. The final order was published with an
incorrect statement in the preamble about whether FDA planned to exempt
the device from premarket notification requirements. This document
corrects that error.
DATES: Effective October 30, 2017
FOR FURTHER INFORMATION CONTACT: Mark Antonino, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G208, Silver Spring, MD 20993-0002, 240-402-9980,
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of July 28, 2017 (82
FR 35067), FDA published the final order ``Medical Devices;
Gastroenterology-Urology Devices; Classification of the Oral Removable
Palatal Space Occupying Device for Weight Management and/or Weight
Loss.'' The final order published with an incorrect statement in the
preamble about whether FDA planned to exempt the device from premarket
notification requirements under section 510(k) of the FD&C Act.
In the Federal Register of July 28, 2017, (82 FR 35067), the
following correction is made: On page 35069, in the first column, the
first paragraph is corrected as follows:
``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), if FDA determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the oral removable palatal space
occupying device for weight management and/or weight loss they intend
to market.''
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23490 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P
