Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 60393-60394 [2015-25352]

Download as PDF Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices B. REMS Data Elements For REMS with ETASU, the REMS data elements describe REMS requirements using a standardized, machine-readable format that permits integration of REMS information into electronic health information technology, including clinical decision support, e-Prescribing systems, and electronic pharmacy systems. FDA has developed terminology to assist in the coding of REMS data elements. This terminology is available as part of the Draft REMS SPL Implementation Guide Excerpt on FDA’s SPL Web site (https:// www.fda.gov/ForIndustry/ DataStandards/ StructuredProductLabeling/ default.htm). The REMS Data Elements do not replace the approved REMS document, which will continue to be the enforceable document establishing the REMS requirements. III. How To Participate in the REMS SPL Pilot tkelley on DSK3SPTVN1PROD with NOTICES A. Participation Volunteers interested in participating in the pilot should contact pilot staff by email at REMS_Standardization@ fda.hhs.gov. The following information should be included in the request: Contact name, contact phone number, and contact email address. FDA will contact interested applicants to discuss the pilot. FDA is seeking a limited number of participants (no more than nine) to participate in this pilot. FDA is also seeking comment from any stakeholder on its proposed approach for capturing REMS information in SPL format in this pilot, as described in section II. B. Procedures To create an SPL file and submit it to FDA, a participant will need the following tools: Appropriate software, knowledge of terminology and standards, and access to FDA’s Electronic Submissions Gateway (ESG) (https://www.fda.gov/ForIndustry/ ElectronicSubmissionsGateway/ default.htm). The ESG is an Agencywide means of accepting electronic regulatory submissions. The FDA ESG enables the secure submission of regulatory submissions. Instructions and information regarding the creation of an SPL file and the converting of REMS information into SPL can be found at https://www.fda.gov/ForIndustry/ DataStandards/ StructuredProductLabeling/default.htm. There should be no additional cost associated with obtaining the software. In 2010, FDA collaborated with Pragmatic Data, LLC (https:// VerDate Sep<11>2014 18:31 Oct 05, 2015 Jkt 238001 www.fda.gov/ForIndustry/ DataStandards/ StructuredProductLabeling/ ucm189651.htm), to make available free SPL authoring software that SPL authors may use to create new SPL documents or edit previous versions. After the SPL is created, the participant would upload the file through the ESG. The Internet portal can be found at https://www.fda.gov/ ForIndustry/ ElectronicSubmissionsGateway/ default.htm. Prior to uploading an SPL file, one must obtain a digital certificate. Instructions regarding obtaining a digital certificate used with FDA’s ESG and uploading the SPL file for submission can be found at https:// www.fda.gov/esg/default.htm. The digital certificate binds together the owner’s name and a pair of electronic keys (a public and a private key) that can be used to encrypt and sign documents. A fee of up to approximately $20 is charged for the digital certificate. Application holders should have already secured a digital certificate because they are required to do so when they register and list. During the pilot, FDA staff will be available to answer any questions or concerns that may arise. Pilot participants will be asked to comment on and discuss their experiences converting their REMS into SPL format. Their comments are expected to assist FDA in its completion of the REMS SPL project. IV. Duration of the REMS SPL Pilot FDA will accept requests for participation in the REMS SPL pilot from October 6, 2015 to December 7, 2015. The pilot will proceed for 4 months, from October 6, 2015 to February 3, 2016. This pilot may be extended as resources and needs allow. V. Paperwork Reduction Act of 1995 This notice 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 314 have been approved under OMB control number 0910–0001. Dated: September 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–25349 Filed 10–5–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 60393 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2015–M–1064, FDA– 2015–M–1065, FDA–2015–M–1177, FDA– 2015–M–1178, FDA–2015–M–1325, FDA– 2015–M–1326, FDA–2015–M–1460, FDA– 2015–M–1461, FDA–2015–M–1557, FDA– 2015–M–1708, FDA–2015–M–1709, FDA– 2015–M–1956, FDA–2015–M–1957, FDA– 2015–M–1958, FDA–2015–M–1959, FDA– 2015–M–2077, FDA–2015–M–2078, FDA– 2014–M–2247] 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. SUMMARY: 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: Melissa Torres, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993–0002, 301–796–5576. 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 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 E:\FR\FM\06OCN1.SGM 06OCN1 60394 Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 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, 2015, through June 30, 2015. 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, 2015 THROUGH JUNE 30, 2015 PMA No., Docket No. Applicant Trade name P140003, FDA–2015–M–1177 P130014, FDA–2015–M–1065 ABIOMED, Inc ........................ HyperBranch Medical Technology, Inc. Medtronic CoreValve, LLC ..... Impella® 2.5 System ................................................................ Adherus® AutoSpray Dural Sealant ......................................... 3/23/2015 3/30/2015 Medtronic CoreValve® System ................................................ 3/30/2015 Advanced Breath Diagnostics, LLC. Alcon Research, Ltd ............... Gastric Emptying Breath Test (GEBT) .................................... 4/6/2015 AcrySof IQ ReSTOR +2.5 D Multifocal Intraocular Lens ........ 4/13/2015 KAMRATM inlay ........................................................................ Barostim neoTM Legacy System .............................................. MAMMOMAT Inspiration with Tomosynthesis Option ............. 4/17/2015 12/12/2014 4/21/2015 Model 5071 Lead ..................................................................... Myopore Sutureless Myocardial Pacing Lead ......................... cobas® KRAS Mutation Test ................................................... Nevro Senza Spinal Cord Stimulation (SCS) System ............. ENROUTETM Transcarotid Stent System ................................ Superion® InterSpinous Spacer ............................................... Misago® Peripheral Self-expanding Stent System .................. Dexcom G4®PLATINUM (Pediatric) Continuous Glucose Monitoring System. PROMUS® ElementTM Plus and Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System (MonorailTM and Over-the-Wire). Radiesse® Injectable Implant ................................................... 4/27/2015 4/30/2015 5/7/2015 5/8/2015 5/18/2015 5/20/2015 5/22/2015 5/22/2015 P130021/S010, FDA–2015–M– 1064. P110015, FDA–2015–M–1178 P040020/S050, FDA–2015–M– 1325. P120023, FDA–2015–M–1326 H130007, FDA–2014–M–2247 P140011, FDA–2015–M–1460 P120017, FDA–2015–M–1461 P130012, FDA–2015–M–1557 P140023, FDA–2015–M–1708 P130022, FDA–2015–M–1709 P140026, FDA–2015–M–1956 P140004, FDA–2015–M–1957 P140002, FDA–2015–M–1958 P120005/S031, FDA–2015–M– 1959. P110010/S096, FDA–2015–M– 2077. P050052/S049, FDA–2015–M– 2078. AcuFocusTM, Inc ..................... CVRx®, Inc ............................. Siemens Medical Solutions USA, Inc. Medtronic, Inc ......................... Greatbatch Medical ................. Roche Molecular Systems, Inc Nevro Corp ............................. Silk Road Medical, Inc ............ Vertiflex®, Inc .......................... Terumo Medical Corp ............. Dexcom, Inc ............................ Boston Scientific Corp ............ Merz North America ................ 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 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–25352 Filed 10–5–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0748] Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Generic Drug User Fee Cover Sheet AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by November 5, 2015. tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:31 Oct 05, 2015 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Approval date 6/1/2015 6/4/2015 To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0727. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: E:\FR\FM\06OCN1.SGM 06OCN1

Agencies

[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60393-60394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25352]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-M-1064, FDA-2015-M-1065, FDA-2015-M-1177, FDA-
2015-M-1178, FDA-2015-M-1325, FDA-2015-M-1326, FDA-2015-M-1460, FDA-
2015-M-1461, FDA-2015-M-1557, FDA-2015-M-1708, FDA-2015-M-1709, FDA-
2015-M-1956, FDA-2015-M-1957, FDA-2015-M-1958, FDA-2015-M-1959, FDA-
2015-M-2077, FDA-2015-M-2078, FDA-2014-M-2247]

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: Melissa Torres, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-5576.

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

[[Page 60394]]

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, 2015, through June 30, 2015.
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, 2015 Through
June 30, 2015
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P140003, FDA-2015-M-1177.............. ABIOMED, Inc............. Impella[supreg] 2.5 System... 3/23/2015
P130014, FDA-2015-M-1065.............. HyperBranch Medical Adherus[supreg] AutoSpray 3/30/2015
Technology, Inc. Dural Sealant.
P130021/S010, FDA-2015-M-1064......... Medtronic CoreValve, LLC. Medtronic CoreValve[supreg] 3/30/2015
System.
P110015, FDA-2015-M-1178.............. Advanced Breath Gastric Emptying Breath Test 4/6/2015
Diagnostics, LLC. (GEBT).
P040020/S050, FDA-2015-M-1325......... Alcon Research, Ltd...... AcrySof IQ ReSTOR +2.5 D 4/13/2015
Multifocal Intraocular Lens.
P120023, FDA-2015-M-1326.............. AcuFocusTM, Inc.......... KAMRATM inlay................ 4/17/2015
H130007, FDA-2014-M-2247.............. CVRx[supreg], Inc........ Barostim neoTM Legacy System. 12/12/2014
P140011, FDA-2015-M-1460.............. Siemens Medical Solutions MAMMOMAT Inspiration with 4/21/2015
USA, Inc. Tomosynthesis Option.
P120017, FDA-2015-M-1461.............. Medtronic, Inc........... Model 5071 Lead.............. 4/27/2015
P130012, FDA-2015-M-1557.............. Greatbatch Medical....... Myopore Sutureless Myocardial 4/30/2015
Pacing Lead.
P140023, FDA-2015-M-1708.............. Roche Molecular Systems, cobas[supreg] KRAS Mutation 5/7/2015
Inc. Test.
P130022, FDA-2015-M-1709.............. Nevro Corp............... Nevro Senza Spinal Cord 5/8/2015
Stimulation (SCS) System.
P140026, FDA-2015-M-1956.............. Silk Road Medical, Inc... ENROUTETM Transcarotid Stent 5/18/2015
System.
P140004, FDA-2015-M-1957.............. Vertiflex[supreg], Inc... Superion[supreg] InterSpinous 5/20/2015
Spacer.
P140002, FDA-2015-M-1958.............. Terumo Medical Corp...... Misago[supreg] Peripheral 5/22/2015
Self-expanding Stent System.
P120005/S031, FDA-2015-M-1959......... Dexcom, Inc.............. Dexcom G4[supreg]PLATINUM 5/22/2015
(Pediatric) Continuous
Glucose Monitoring System.
P110010/S096, FDA-2015-M-2077......... Boston Scientific Corp... PROMUS[supreg] ElementTM Plus 6/1/2015
and Promus PREMIERTM
Everolimus-Eluting Platinum
Chromium Coronary Stent
System (MonorailTM and Over-
the-Wire).
P050052/S049, FDA-2015-M-2078......... Merz North America....... Radiesse[supreg] Injectable 6/4/2015
Implant.
----------------------------------------------------------------------------------------------------------------

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 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25352 Filed 10-5-15; 8:45 am]
BILLING CODE 4164-01-P

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