Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 57940-57941 [2014-22987]

Download as PDF 57940 Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices particular diagnosis, prognosis, and monitoring or risk assessment. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on content and format for abbreviated 510(k)s for early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization devices. 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 statute and regulations. mstockstill on DSK4VPTVN1PROD with NOTICES III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400030 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to currently approved collections of information found in FDA regulations.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 807, subpart E, are currently approved under OMB control number 0910–0120 and the collections of information in 21 CFR part 809.10 are currently approved under 0910–0485. V. 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 VerDate Sep<11>2014 19:14 Sep 25, 2014 Jkt 232001 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. Dated: September 22, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–22973 Filed 9–25–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2006–D–0031] Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice; reopening of the comment period. ACTION: The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance document entitled ‘‘Informed Consent Information Sheet.’’ A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of July 15, 2014. The Agency is reopening the comment period to update comments and to receive any new information. DATES: Submit either electronic or written comments by October 27, 2014. ADDRESSES: Submit electronic comments 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: Marsha Melvin, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Building 32, Silver Spring, MD 20993, marsha.melvin@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background In the Federal Register of July 15, 2014 (79 FR 41291), FDA published a notice of availability with a 60-day comment period to request comments on the draft guidance document entitled ‘‘Informed Consent Information Sheet.’’ PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 The Agency has received a request for a 30-day extension of the comment period for the draft guidance. The request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the draft guidance. FDA is reopening the comment period for 30 days. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying finalizing the guidance on these important issues. II. Request for 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. Dated: September 19, 2014 Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–22951 Filed 9–25–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2014–M–0327, FDA– 2014–M–0434, FDA–2014–M–0552, FDA– 2014–M–0553, FDA–2014–M–0690; FDA– 2014–M–0691, FDA–2014–M–0692, FDA– 2014–M–0726, FDA–2014–M–0727, FDA– 2014–M–0866, and FDA–2014–M–0872] 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 SUMMARY: E:\FR\FM\26SEN1.SGM 26SEN1 Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices 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 (21 U.S.C. 360e(g)). 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 57941 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, 2014, through June 30, 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 APRIL 1, 2014, THROUGH JUNE 30, 2014 PMA No., Docket No. Applicant Trade name P130016, FDA–2014– M–0327. P120020, FDA–2014– M–0434. P010015/S205, FDA– 2014–M–0553. P010031/S381, FDA– 2014–M–0553. P100020/S008, FDA– 2014–M–0552. P130008, FDA–2014– M–0690. P110005, FDA–2014– M–0691. P110041, FDA–2014– M–0692. Cochlear Americas .............................. Nucleus® HybridTM L24 Cochlear Implant System ........... March 20, 2014. Abbott Vascular (IDEV Technologies, Inc.). Medtronic, Inc ..................................... SUPERA® Peripheral Stent System .................................. March 28, 2014. April 10, 2014. Roche Molecular Systems, Inc ........... Cardiac Resynchronization Therapy Pacemaker (CRT–P) Devices. Cardiac Resynchronization Therapy Defibrillator (CRT–D) Devices. cobas® HPV Test .............................................................. April 24, 2014. Inspire Medical Systems, Inc .............. Inspire Upper Airway Stimulation (UAS) system ............... April 30, 2014. IBSA Institut Biochimique SA ............. Gel-SynTM Sinovial (Sodium Hyaluronate 0.8%) .............. May 9, 2014. Siemens Healthcare Diagnostics ........ May 16, 2014. P110027, FDA–2014– M–0726. P100045, FDA–2014– M–0727. P130027, FDA–2014– M–0866. P040024/S072, FDA– 2014–M–0872. QIAGEN Manchester Ltd .................... ADVIA Centaur® HBsAgII, ADVIA Centaur® HBsAg Confirmatory and ADVIA Centaur® HBsAg Quality Control Material. therascreen® KRAS RGQ PCR Kit ................................... CardioMEMS, Inc ................................ CardioMEMSTM HF System .............................................. May 28, 2014. QIAGEN, Inc ....................................... artus® CMV RGQ MDx Kit ................................................ June 2, 2014. Valeant Pharmaceuticals North America LLC/Medicis. Restylane Silk Injectable Gel ............................................. June 13, 2014. Medtronic, Inc ..................................... II. Electronic Access mstockstill on DSK4VPTVN1PROD with NOTICES Persons with access to the Internet may obtain the documents at https:// www.fda.gov/MedicalDevices/Products andMedicalProcedures/Device ApprovalsandClearances/PMA Approvals/default.htm. Dated: September 23, 2014 Leslie Kux, Assistant Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. Notice. [FR Doc. 2014–22987 Filed 9–25–14; 8:45 am] ACTION: BILLING CODE 4164–01–P This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. VerDate Sep<11>2014 19:14 Sep 25, 2014 Jkt 232001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 Approval date April 10, 2014. May 23, 2014. Name of Committee: Ophthalmic Devices Panel of the Medical Devices 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 November 14, 2014, from 8 a.m. to 6 p.m. Location: Hilton Washington, DC North/Gaithersburg, Montgomery Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel’s telephone number is 301–977–8900. Contact Person: Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. E:\FR\FM\26SEN1.SGM 26SEN1

Agencies

[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 57940-57941]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22987]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-M-0327, FDA-2014-M-0434, FDA-2014-M-0552, FDA-
2014-M-0553, FDA-2014-M-0690; FDA-2014-M-0691, FDA-2014-M-0692, FDA-
2014-M-0726, FDA-2014-M-0727, FDA-2014-M-0866, and FDA-2014-M-0872]

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

[[Page 57941]]

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 (21
U.S.C. 360e(g)). 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, 2014, through June 30, 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 April 1, 2014, Through
June 30, 2014
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P130016, FDA-2014-M-0327............. Cochlear Americas...... Nucleus[supreg] March 20, 2014.
Hybrid\TM\ L24
Cochlear Implant
System.
P120020, FDA-2014-M-0434............. Abbott Vascular (IDEV SUPERA[supreg] March 28, 2014.
Technologies, Inc.). Peripheral Stent
System.
P010015/S205, FDA-2014-M-0553........ Medtronic, Inc......... Cardiac April 10, 2014.
Resynchronization
Therapy Pacemaker (CRT-
P) Devices.
P010031/S381, FDA-2014-M-0553........ Medtronic, Inc......... Cardiac April 10, 2014.
Resynchronization
Therapy Defibrillator
(CRT-D) Devices.
P100020/S008, FDA-2014-M-0552........ Roche Molecular cobas[supreg] HPV Test. April 24, 2014.
Systems, Inc.
P130008, FDA-2014-M-0690............. Inspire Medical Inspire Upper Airway April 30, 2014.
Systems, Inc. Stimulation (UAS)
system.
P110005, FDA-2014-M-0691............. IBSA Institut Gel-Syn\TM\ Sinovial May 9, 2014.
Biochimique SA. (Sodium Hyaluronate
0.8%).
P110041, FDA-2014-M-0692............. Siemens Healthcare ADVIA Centaur[supreg] May 16, 2014.
Diagnostics. HBsAgII, ADVIA
Centaur[supreg] HBsAg
Confirmatory and ADVIA
Centaur[supreg] HBsAg
Quality Control
Material.
P110027, FDA-2014-M-0726............. QIAGEN Manchester Ltd.. therascreen[supreg] May 23, 2014.
KRAS RGQ PCR Kit.
P100045, FDA-2014-M-0727............. CardioMEMS, Inc........ CardioMEMS\TM\ HF May 28, 2014.
System.
P130027, FDA-2014-M-0866............. QIAGEN, Inc............ artus[supreg] CMV RGQ June 2, 2014.
MDx Kit.
P040024/S072, FDA-2014-M-0872........ Valeant Pharmaceuticals Restylane Silk June 13, 2014.
North America LLC/ Injectable Gel.
Medicis.
----------------------------------------------------------------------------------------------------------------

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: September 23, 2014
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22987 Filed 9-25-14; 8:45 am]
BILLING CODE 4164-01-P

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