Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 22527-22528 [2015-09298]
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Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm, or https://
www.regulations.gov.
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
Agency’s Division of Dockets
Management.
Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–09303 Filed 4–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2014–M–1452, FDA–
2014–M–1596, FDA–2014–M–1597, FDA–
2014–M–1599, FDA–2014–M–1735, FDA–
2014–M–1736, FDA–2014–M–2042, FDA–
2014–M–2246, FDA–2014–M–2248, and
FDA–2014–M–2376]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
number as listed in table 1 when
submitting a written request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the summaries of
safety and effectiveness.
FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring,
MD 20993–0002, 301–796–6570.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
In accordance with sections 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
Notice.
The Food and Drug
Administration (FDA) is publishing a
SUMMARY:
22527
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the FD&C
Act. The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from October 1, 2014, through
December 31, 2014. There were no
denial actions during this period. The
list provides the manufacturer’s name,
the product’s generic name or the trade
name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1,
2014, THROUGH DECEMBER 31, 2014
PMA No., Docket No.
Applicant
Trade name
P040037/S060, FDA–2014–M–1452 ...............
P070015/S122, FDA–2014–M–1596 ...............
W.L. Gore & Associates, Inc.
Abbott Vascular, Inc ...
P110019/S066, FDA–2014–M–1596 ...............
Abbott Vascular, Inc ...
P130024, FDA–2014–M–1597 .........................
Lutonix, Inc .................
P110023/S007, FDA–2014–M–1599 ...............
ev3, Inc .......................
P120005/S018, FDA–2014–M–1735 ...............
Dexcom, Inc ...............
P130026, FDA–2014–M–1736 .........................
St. Jude Medical ........
P120011, FDA–2014–M–2042 .........................
P130007, FDA–2014–M–2246 .........................
P140020, FDA–2014–M–2248 .........................
Ideal Implant, Inc ........
Animas Corp ..............
Myriad Genetic Laboratories, Inc.
Suneva Medical, Inc ...
GORE VIABAHN Endoprosthesis, GORE
VIABAHN Endoprosthesis with Heparin.
XIENCE V® and XIENCE nano® Everolimus
Eluting Coronary Stent System.
XIENCE PRIME® and XIENCE PRIME LL
Everlimus Eluting Coronary Stent System.
Lutonix 035 Drug Coated Balloon PTA Catheter.
EverFlexTM Self-Expanding Peripheral Stent
System.
Dexcom G4TM PLATINUM Continuous Glucose Monitoring System.
TactiCath
Quartz®
Catheter
and
TactiSysQuartz® Equipment.
IDEAL IMPLANT® Saline-filled Breast Implant
Animas Vibe System .......................................
BRACAnalysis CDxTM ....................................
November 14, 2014.
November 25, 2014.
December 19, 2014.
Bellafill .............................................................
December 23, 2014.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
P020012/S009, FDA–2014–M–2376 ...............
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Approval date
22APN1
September 19, 2014.
October 3, 2014.
October 3, 2014.
October 9, 2014.
October 10, 2014.
October 21, 2014.
October 24, 2014.
22528
Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/
DeviceApprovalsandClearances/
PMAApprovals/default.htm.
Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–09298 Filed 4–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–E–0131]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; COMETRIQ
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
COMETRIQ and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions (two copies are required) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Food and Drug
Administration, 10001 New Hampshire
Ave., Hillandale Campus, Rm. 3180,
Silver Spring, MD 20993, 301–796–
7900.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ADDRESSES:
The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:00 Apr 21, 2015
Jkt 235001
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product COMETRIQ
(cabozanitinib (S)-maleate). COMETRIQ
is indicated for the treatment of patients
with progressive, metastatic medullary
thyroid cancer. Subsequent to this
approval, the USPTO received a patent
term restoration application for
COMETRIQ (U.S. Patent No. 7,579,473)
from Exelixis, Incorporated, and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
March 27, 2014, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
COMETRIQ represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
FDA has determined that the
applicable regulatory review period for
COMETRIQ is 2,698 days. Of this time,
2,513 days occurred during the testing
phase of the regulatory review period,
while 185 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: July 13,
2005. FDA has verified the applicant’s
claim that the date the investigational
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new drug application became effective
was on July 13, 2005.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: May 29, 2012.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
COMETRIQ (NDA 203756) was
submitted on May 29, 2012.
3. The date the application was
approved: November 29, 2012. FDA has
verified the applicant’s claim that NDA
203756 was approved on November 29,
2012.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 688 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by June 22, 2015.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
October 19, 2015. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written or electronic
petitions. It is only necessary to send
one set of comments. Identify comments
with the docket number found in
brackets in the heading of this
document. If you submit a written
petition, two copies are required. A
petition submitted electronically must
be submitted to https://
www.regulations.gov, Docket No. FDA–
2013–S–0610. Comments and petitions
that have not been made publicly
available on https://www.regulations.gov
may be viewed in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–09302 Filed 4–21–15; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\22APN1.SGM
22APN1
]]>Agencies
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22527-22528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09298]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2014-M-1452, FDA-2014-M-1596, FDA-2014-M-1597, FDA-
2014-M-1599, FDA-2014-M-1735, FDA-2014-M-1736, FDA-2014-M-2042, FDA-
2014-M-2246, FDA-2014-M-2248, and FDA-2014-M-2376]
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
Agency's Division of Dockets Management.
ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 when submitting a written request. See the SUPPLEMENTARY INFORMATION
section for electronic access to the summaries of safety and
effectiveness.
FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with sections 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec. 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from October 1, 2014, through December 31,
2014. There were no denial actions during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.
Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From October 1, 2014,
Through December 31, 2014
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P040037/S060, FDA-2014-M-1452........ W.L. Gore & Associates, GORE VIABAHN September 19, 2014.
Inc. Endoprosthesis, GORE
VIABAHN Endoprosthesis
with Heparin.
P070015/S122, FDA-2014-M-1596........ Abbott Vascular, Inc... XIENCE V[supreg] and October 3, 2014.
XIENCE nano[supreg]
Everolimus Eluting
Coronary Stent System.
P110019/S066, FDA-2014-M-1596........ Abbott Vascular, Inc... XIENCE PRIME[supreg] October 3, 2014.
and XIENCE PRIME LL
Everlimus Eluting
Coronary Stent System.
P130024, FDA-2014-M-1597............. Lutonix, Inc........... Lutonix 035 Drug Coated October 9, 2014.
Balloon PTA Catheter.
P110023/S007, FDA-2014-M-1599........ ev3, Inc............... EverFlexTM Self- October 10, 2014.
Expanding Peripheral
Stent System.
P120005/S018, FDA-2014-M-1735........ Dexcom, Inc............ Dexcom G4TM PLATINUM October 21, 2014.
Continuous Glucose
Monitoring System.
P130026, FDA-2014-M-1736............. St. Jude Medical....... TactiCath October 24, 2014.
Quartz[supreg]
Catheter and
TactiSysQuartz[supreg]
Equipment.
P120011, FDA-2014-M-2042............. Ideal Implant, Inc..... IDEAL IMPLANT[supreg] November 14, 2014.
Saline-filled Breast
Implant.
P130007, FDA-2014-M-2246............. Animas Corp............ Animas Vibe System..... November 25, 2014.
P140020, FDA-2014-M-2248............. Myriad Genetic BRACAnalysis CDxTM..... December 19, 2014.
Laboratories, Inc.
P020012/S009, FDA-2014-M-2376........ Suneva Medical, Inc.... Bellafill.............. December 23, 2014.
----------------------------------------------------------------------------------------------------------------
[[Page 22528]]
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.
Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09298 Filed 4-21-15; 8:45 am]
BILLING CODE 4164-01-P
