Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 24425-24426 [2013-09759]

Download as PDF Federal Register / Vol. 78, No. 80 / Thursday, April 25, 2013 / Notices be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2013–09797 Filed 4–24–13; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0642] Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Assay Migration Studies for In Vitro Diagnostic Devices.’’ This guidance presents a least burdensome regulatory approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously approved assay is migrating (i.e., transitioning) to a new system for which the assay has not been previously approved, licensed, or cleared. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Assay Migration Studies for In Vitro Diagnostic Devices’’ to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301– 847–8149. Alternatively, you may submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), 1401 Rockville Pike, suite 200N, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section for tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:22 Apr 24, 2013 Jkt 229001 information on electronic access to the guidance. Submit electronic comments on the guidance to http://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. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5524, Silver Spring, MD 20993–002, 301–796–5455. For further information concerning the study designs in the guidance: Marina V. Kondratovich, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5666, Silver Spring, MD 20993–002, 301–796–6036. For further information concerning the guidance as it relates to devices regulated by CBER: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry and FDA staff entitled ‘‘Assay Migration Studies for In Vitro Diagnostic Devices.’’ This guidance presents a least burdensome regulatory approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously approved assay is migrating (i.e., transitioning) to a new system for which the assay has not been previously approved or licensed. The approach in this guidance is also applicable for some 510(k) cleared devices for which transition to a new system presents specific concerns, either because of the nature of the analyte and indications, or because of the specific technology used (e.g., nucleic acid amplification tests). The focus of this guidance is on the study designs and performance criteria that should be fulfilled in order for a sponsor to utilize the migration study approach in support of the change. The FDA believes that the assay migration study paradigm discussed in this guidance provides a least burdensome scientific and regulatory pathway for manufacturers to transfer a previously approved or licensed assay with full PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 24425 clinical data from an old system to a new system (previously not approved or licensed). The paradigm is suitable in cases when sufficient knowledge can be derived from the documentation of design controls, risk analyses, and prior performance studies on an old system. The draft of this guidance was issued on January 5, 2009 (74 FR 302). The comment period closed on April 6, 2009. Three sets of comments were received and reviewed by FDA. The guidance was updated to address comments where appropriate. The updated guidance contains additional examples and explanations and supersedes the draft guidance ‘‘Assay Migration Studies for In Vitro Diagnostic Devices’’ issued on January 5, 2009. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on ‘‘migration studies’’ for in vitro diagnostic device. 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. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. To receive ‘‘Assay Migration Studies for In Vitro Diagnostic Devices,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301–847–8149 to receive a hard copy. Please use the document number 1660 to identify the guidance you are requesting. Guidance documents are also available on the CBER Internet site at http://www.fda. gov/BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ default.htm. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations and guidance documents. 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 E:\FR\FM\25APN1.SGM 25APN1 24426 Federal Register / Vol. 78, No. 80 / Thursday, April 25, 2013 / Notices collections of information in 21 CFR part 807 subpart E have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910–0231; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073; and the collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338. V. Comments Interested persons may submit either electronic comments regarding this document to http://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 http:// www.regulations.gov. Dated: April 19, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–09759 Filed 4–24–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0293] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. tkelley on DSK3SPTVN1PROD with NOTICES ACTION: Notice. 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. Name of Committee: Orthopaedic and Rehabilitation 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 July 24 and 25, 2013, from 8 a.m. to 6 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone number is 301–977–8900. VerDate Mar<15>2010 17:22 Apr 24, 2013 Jkt 229001 Contact Person: Sara J. Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993– 0002, 301–796–7047, Sara.Anderson@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 http:// 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 July 24, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. The Kineflex/C is indicated for reconstruction of the intervertebral disc at one level from C3– C7 following single-level discectomy for intractable radiculopathy or myelopathy due to a single-level abnormality localized to the disc space. On July 25, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. The Kineflex Lumbar Artificial Disc is indicated for reconstruction of the intervertebral disc at one level (L4–L5 or L5–S1) following single-level discectomy for lumbar degenerative disc disease (DDD) where DDD is defined as discogenic back pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after PO 00000 Frm 00047 Fmt 4703 Sfmt 9990 the meeting. Background material is available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before July 15, 2013. Oral presentations from the public will be scheduled on July 24 and 25, 2013, between approximately 11:30 a.m. and 12:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before July 5, 2013. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by July 8, 2013. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams at Annmarie.Williams@fda.hhs.gov or 301–796–5966 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 19, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–09744 Filed 4–24–13; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\25APN1.SGM 25APN1

Agencies

[Federal Register Volume 78, Number 80 (Thursday, April 25, 2013)]
[Notices]
[Pages 24425-24426]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09759]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0642]


Assay Migration Studies for In Vitro Diagnostic Devices; Guidance 
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Assay Migration Studies for In 
Vitro Diagnostic Devices.'' This guidance presents a least burdensome 
regulatory approach to gain FDA approval of Class III or certain 
licensed in vitro diagnostic devices in cases when a previously 
approved assay is migrating (i.e., transitioning) to a new system for 
which the assay has not been previously approved, licensed, or cleared.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Assay Migration Studies for In Vitro Diagnostic 
Devices'' to the Division of Small Manufacturers, International and 
Consumer Assistance, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
301-847-8149. Alternatively, you may submit written requests for single 
copies of the guidance to the Office of Communication, Outreach and 
Development (HFM-40), Center for Biologics Evaluation and Research 
(CBER), 1401 Rockville Pike, suite 200N, Rockville, MD 20852. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the guidance to http://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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5524, Silver Spring, MD 20993-002, 301-796-5455.
    For further information concerning the study designs in the 
guidance:

Marina V. Kondratovich, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5666, Silver Spring, MD 20993-002, 301-796-6036.

    For further information concerning the guidance as it relates to 
devices regulated by CBER:

Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 
20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document for industry and FDA staff entitled 
``Assay Migration Studies for In Vitro Diagnostic Devices.'' This 
guidance presents a least burdensome regulatory approach to gain FDA 
approval of Class III or certain licensed in vitro diagnostic devices 
in cases when a previously approved assay is migrating (i.e., 
transitioning) to a new system for which the assay has not been 
previously approved or licensed. The approach in this guidance is also 
applicable for some 510(k) cleared devices for which transition to a 
new system presents specific concerns, either because of the nature of 
the analyte and indications, or because of the specific technology used 
(e.g., nucleic acid amplification tests). The focus of this guidance is 
on the study designs and performance criteria that should be fulfilled 
in order for a sponsor to utilize the migration study approach in 
support of the change. The FDA believes that the assay migration study 
paradigm discussed in this guidance provides a least burdensome 
scientific and regulatory pathway for manufacturers to transfer a 
previously approved or licensed assay with full clinical data from an 
old system to a new system (previously not approved or licensed). The 
paradigm is suitable in cases when sufficient knowledge can be derived 
from the documentation of design controls, risk analyses, and prior 
performance studies on an old system.
    The draft of this guidance was issued on January 5, 2009 (74 FR 
302). The comment period closed on April 6, 2009. Three sets of 
comments were received and reviewed by FDA. The guidance was updated to 
address comments where appropriate. The updated guidance contains 
additional examples and explanations and supersedes the draft guidance 
``Assay Migration Studies for In Vitro Diagnostic Devices'' issued on 
January 5, 2009.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on ``migration studies'' for in vitro 
diagnostic device. 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.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Assay Migration Studies for In Vitro Diagnostic Devices,'' you may 
either send an email request to dsmica@fda.hhs.gov to receive an 
electronic copy of the document or send a fax request to 301-847-8149 
to receive a hard copy. Please use the document number 1660 to identify 
the guidance you are requesting. Guidance documents are also available 
on the CBER Internet site at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations and guidance documents. 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

[[Page 24426]]

collections of information in 21 CFR part 807 subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 814 have been approved under OMB control 
number 0910-0231; the collections of information in 21 CFR part 820 
have been approved under OMB control number 0910-0073; and the 
collections of information in 21 CFR part 601 have been approved under 
OMB control number 0910-0338.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://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 http://www.regulations.gov.

    Dated: April 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09759 Filed 4-24-13; 8:45 am]
BILLING CODE 4160-01-P