Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 50422-50423 [2013-20085]

Download as PDF 50422 Federal Register / Vol. 78, No. 160 / Monday, August 19, 2013 / Notices electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Melissa Reisman, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: TKELLEY on DSK3SPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a guidance document entitled ‘‘Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria’’ dated August 2013. The guidance document provides blood establishments that collect blood and blood components with recommendations for questioning and deferring donors of blood and blood components, and allowing their reentry, to reduce the risk of transfusiontransmitted malaria. This guidance document also provides recommendations for product management, including recommendations regarding product retrieval and quarantine, and notification of consignees of blood and blood components in the event that a blood establishment determines that blood or blood components have been collected from a donor who should have been deferred due to possible malaria risk. Finally, the guidance contains recommendations on the implementation of FDA’s recommendations, including how licensed blood establishments must report to FDA the changes made to their donor history questionnaires to reflect the new donor deferral recommendations. In the Federal Register of July 6, 2012 (77 FR 40068), FDA announced the availability of the draft guidance of the same title dated June 2012. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. Significant changes to the guidance include: revisions to the definition of malaria-endemic area, malaria-endemic country and other terms used to assess a donor’s risk of malaria based on history of travel or residence; and revisions to the VerDate Mar<15>2010 17:51 Aug 16, 2013 Jkt 229001 recommendations regarding consignee notification and reporting of biological product deviations for acellular blood components collected from a donor at risk for malaria. Based on the revised definition of malaria-endemic area and current epidemiological data, donors who travel to the Mexican States of Quintana Roo or Jalisco would be eligible for donation without any deferral, provided the donors meet all other eligibility criteria. However, if malaria transmission in these States changes over time, the donor deferral recommendations would encompass donors who travel to these areas. The guidance announced in this notice finalizes the draft guidance dated June 2012, and supersedes the FDA memorandum to all registered blood establishments entitled ‘‘Recommendations for Deferral of Donors for Malaria Risk,’’ dated July 26, 1994. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. 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 21 CFR part 640 and 21 CFR 630.6 have been approved under OMB control number 0910–0116. The collections of information in 21 CFR 606.171 have been approved under OMB control number 0910–0458. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/ BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov. Dated: August 13, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–19962 Filed 8–16–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2013–M–0462, FDA– 2013–M–0463, FDA–2013–M–0464, FDA– 2013–M–0549, FDA–2013–M–0592, FDA– 2013–M–0594, FDA–2013–M–0595, FDA– 2013–M–0709, FDA–2013–M–0724, FDA– 2013–M–0738, and FDA–2013–M–0758] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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: SUMMARY: 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. E:\FR\FM\19AUN1.SGM 19AUN1 50423 Federal Register / Vol. 78, No. 160 / Monday, August 19, 2013 / Notices 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 § 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 April 1, 2013, through June 30, 2013. 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 APRIL 1, 2013, THROUGH JUNE 30, 2013 PMA No., Docket No. Applicant Trade name P120016, FDA–2013–M–0592 .... P070026/S004, FDA–2013–M– 0462. P960043/S080, FDA–2013–M– 0464. P980040/S039, FDA–2013–M– 0463. P080009, FDA–2013–M–0549 .... Cardiva Medical, Inc. .................. DePuy Orthopaedics, Inc. .......... VASCADE Vascular Closure System (VCS) ........ DuPuy Ceramax Ceramic Total Hip System ........ January 31, 2013. April 2, 2013. Abbott Vascular .......................... April 15, 2013. P120019, FDA–2013–M–0594 .... P080003/S001, FDA–2013–M– 0595. P030002/S027, FDA–2013–M– 0724. P120014, FDA–2013–M–0709 .... Roche Molecular Systems, Inc. Hologic, Inc. ................................ PERCLOSE PROGLIDE Suture Mediated Closure System. TECNIS Toric 1-Piece Intraocular Lens (IOL) and the TECNIS Toric Calculator System. SEDASYS Computer-Assisted Personalized Sedation System. COBAS EGFR Mutation Test ............................... Selenia Dimensions 3D System ........................... P060028, FDA–2013–M–0738 .... P120012, FDA–2013–M–0758 .... Mentor Worldwide LLC ............... Abbott Molecular, Inc. ................ Abbott Medical Optics, Inc. ........ Ethicon Endo-Surgery, Inc. ........ Bausch+Lomb, Inc. .................... ´ bioMerieux, Inc. .......................... 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: August 13, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–20085 Filed 8–16–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration TKELLEY on DSK3SPTVN1PROD with NOTICES [Docket No. FDA–2013–N–0001] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration VerDate Mar<15>2010 17:51 Aug 16, 2013 Jkt 229001 TRULIGN Toric Posterior Chamber Intraocular Lens. THxID BRAF Kit for use on the ABI 7500 Fast DX Real-Time PCR Instrument. MEMORYSHAPE Breast Implants ....................... Abbott RealTime HCV Genotype II, Abbott RealTime HCV Genotype II Control Kit, and Uracil-N-Glycosylase (UNG). (FDA). The meeting will be open to the public. Name of Committee: Endocrinologic and Metabolic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on October 16, 2013, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Stephanie L. Begansky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, PO 00000 Frm 00051 Approval date Fmt 4703 Sfmt 4703 April 15, 2013. May 3, 2013. May 14, 2013. May 16, 2013. May 20, 2013. May 29, 2013. June 14, 2013. June 20, 2013. MD 20993–0002, 301–796–9001, FAX: 301–847–8533, email: EMDAC@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On October 16, 2013, the committee will discuss the supplemental new drug application 202057/S–005, VASCEPA (icosapent ethyl) capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. VASCEPA is currently approved as monotherapy for the treatment of severe hypertriglyceridemia. This supplemental application proposes E:\FR\FM\19AUN1.SGM 19AUN1

Agencies

[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Notices]
[Pages 50422-50423]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20085]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-M-0462, FDA-2013-M-0463, FDA-2013-M-0464, FDA-
2013-M-0549, FDA-2013-M-0592, FDA-2013-M-0594, FDA-2013-M-0595, FDA-
2013-M-0709, FDA-2013-M-0724, FDA-2013-M-0738, and FDA-2013-M-0758]

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.

[[Page 50423]]

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 April 1, 2013, through June 30, 2013.
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 April 1, 2013, Through
June 30, 2013
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P120016, FDA-2013-M-0592..... Cardiva Medical, Inc. VASCADE Vascular Closure January 31, 2013.
System (VCS).
P070026/S004, FDA-2013-M-0462 DePuy Orthopaedics, DuPuy Ceramax Ceramic Total April 2, 2013.
Inc.. Hip System.
P960043/S080, FDA-2013-M-0464 Abbott Vascular...... PERCLOSE PROGLIDE Suture April 15, 2013.
Mediated Closure System.
P980040/S039, FDA-2013-M-0463 Abbott Medical TECNIS Toric 1-Piece April 15, 2013.
Optics, Inc.. Intraocular Lens (IOL) and
the TECNIS Toric Calculator
System.
P080009, FDA-2013-M-0549..... Ethicon Endo-Surgery, SEDASYS Computer-Assisted May 3, 2013.
Inc.. Personalized Sedation System.
P120019, FDA-2013-M-0594..... Roche Molecular COBAS EGFR Mutation Test...... May 14, 2013.
Systems, Inc..
P080003/S001, FDA-2013-M-0595 Hologic, Inc......... Selenia Dimensions 3D System.. May 16, 2013.
P030002/S027, FDA-2013-M-0724 Bausch+Lomb, Inc..... TRULIGN Toric Posterior May 20, 2013.
Chamber Intraocular Lens.
P120014, FDA-2013-M-0709..... bioM[eacute]rieux, THxID BRAF Kit for use on the May 29, 2013.
Inc.. ABI 7500 Fast DX Real-Time
PCR Instrument.
P060028, FDA-2013-M-0738..... Mentor Worldwide LLC. MEMORYSHAPE Breast Implants... June 14, 2013.
P120012, FDA-2013-M-0758..... Abbott Molecular, Abbott RealTime HCV Genotype June 20, 2013.
Inc.. II, Abbott RealTime HCV
Genotype II Control Kit, and
Uracil-N-Glycosylase (UNG).
----------------------------------------------------------------------------------------------------------------

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: August 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20085 Filed 8-16-13; 8:45 am]
BILLING CODE 4160-01-P

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