Document ID: FDA-2018-M-3870-0002
Agency: fda
Document Type: Notice
Title: Safety and Effectiveness Summaries for Premarket Approval Applications: Medical Devices Regulated by the Center for Biologics Evaluation and Research
Posted Date: 2019-03-07T05:00Z

[Federal Register Volume 84, Number 45 (Thursday, March 7, 2019)]
[Notices]
[Pages 8333-8334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04114]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-M-6870, FDA-2018-M-3584, and FDA-2018-M-3870]

Medical Devices Regulated by the Center for Biologics Evaluation 
and Research; Availability of Safety and Effectiveness Summaries for 
Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing 
a list of premarket approval applications (PMAs) that have been 
approved by the Center for Biologics Evaluation and Research (CBER). 
This list is intended to inform the public of the availability of 
safety and effectiveness summaries of approved PMAs through the 
internet and FDA's Dockets Management Staff.

ADDRESSES: You may submit either electronic or written comments at any 
time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Since your comment will be made 
public, you are solely responsible for ensuring that your comment does 
not include any confidential information that you or a third party may 
not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment as well as any 
attachments, except for information submitted, marked, and identified 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos. 
FDA-2017-M-6870, FDA-2018-M-3584, and FDA-2018-M-3870 for ``Medical 
Devices Regulated by the Center for Biologics Evaluation and Research; 
Availability of Safety and Effectiveness Summaries for Premarket 
Approval Applications.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9

[[Page 8334]]

a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies, total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments, and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations .gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gretchen Opper, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 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 administrative 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 (21 CFR 814.44(d) and 814.45(d)) 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 PMAs approved by CBER for which 
safety and effectiveness summaries were placed on the internet from 
October 1, 2017, through December 31, 2018. 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, 2017,
                                            Through December 31, 2018
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        PMA No./Docket No.                   Applicant                  Trade name              Approval date
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BP160122, FDA-2017-M-6870.........  Ortho-Clinical              VITROS Immunodiagnostic     December 13, 2017.
                                     Diagnostics, Inc.           Products HIV Combo
                                                                 Reagent Pack & VITROS
                                                                 Immunodiagnostic Products
                                                                 HIV Combo Calibrator.
BP170122, FDA-2018-M-3584.........  Avita Medical Americas,     RECELL Autologous Cell      September 20, 2018.
                                     LLC.                        Harvesting Device.
BP170154, FDA-2018-M-3870.........  Progenika Biopharma, S.A..  ID CORE XT (Reagents and    October 11, 2018.
                                                                 Analysis Software).
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II. Electronic Access

    Persons with access to the internet may obtain the documents at 
https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/default.htm.

    Dated: March 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04114 Filed 3-6-19; 8:45 am]
 BILLING CODE 4164-01-P