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

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) 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 the Agency's Division of Dockets Management.


You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to will be posted to the docket unchanged. Because 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
  • 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, 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-2015-M-3249, FDA-2015-M-3251, FDA-2015-M-3253, FDA-2015-M-4130, 2015-M-3254, FDA-2016-M-2210, FDA-2014-M-0740, FDA-2016-M-1072, FDA-2014-M-2304, FDA-2014-M-2305, FDA-2015-M-2100, FDA-2015-M-3255, FDA-2015-M-4981 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 or at the Division of Dockets Start Printed Page 81783Management between 9 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 Submit both copies to the Division of Dockets Management. 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:​regulatoryinformation/​dockets/​default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to 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 Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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Jonathan McKnight, 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.

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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 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, 2010, through September 30, 2016. 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, 2010, Through September 30, 2016

PMA No., Docket No.ApplicantTrade nameApproval date
BP090032, FDA-2015-M-3249bioLytical Laboratories IncINSTI HIV-1 Antibody Test KitNovember 29, 2010.
BP100064, FDA-2015-M-3251Bio-Rad Laboratories, IncGS HIV Combo Ag/Ab EIAJuly 22, 2011.
BP120001, FDA-2015-M-3253OraSure Technologies, IncOraQuick® In-Home HIV TestJuly 3, 2012.
BP120032, FDA-2015-M-4130Chembio Diagnostic Systems, IncDPP HIV 1/2 AssayDecember 12, 2012.
BP120037, FDA-2015-M-3254Alere Scarborough, IncAlere DetermineTM HIV-1/2 Ag/Ab ComboAugust 9, 2013.
BH110018, FDA-2016-M-2210Miltenyi Biotec, IncCliniMACs CD34 Reagent SystemJanuary 23, 2014.
BP130026, FDA-2014-M-0740BioArray Solutions, LtdImmucor PreciseTypeTM Human Erythrocyte Antigen Molecular BeadChip TestMay 21, 2014.
BP140120, FDA-2016-M-1072Bio-Rad Laboratories, IncBio-Rad Geenius HIV 1/2 Supplemental AssayOctober 24, 2014.
BP130076, FDA-2014-M-2304Cerus CorporationINTERCEPT® Blood System for PlasmaDecember 16, 2014.
BP140143, FDA-2014-M-2305Cerus CorporationINTERCEPT® Blood System for PlateletsDecember 18, 2014.
BP140103, FDA-2015-M-2100Siemens Healthcare Diagnostics, IncADVIA Centaur HIV Ag/Ab Combo (CHIV) AssayJune 8, 2015.
BP140111, FDA-2015-M-3255Bio-Rad Laboratories, IncBioPlex® 2200 HIV Ag-AbJuly 22, 2015.
BP150262, FDA-2015-M-4981Roche Molecular Systems, IncCobas HIV-1December 18, 2015.

II. Electronic Access

Persons with access to the Internet may obtain the documents at​BiologicsBloodVaccines/​BloodBloodProducts/​ApprovedProducts/​PremarketApprovalsPMAs/​default.htm.

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Dated: November 14, 2016.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2016-27769 Filed 11-17-16; 8:45 am]