Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems; Availability, 11987-11988 [05-4759]

Download as PDF Federal Register / Vol. 70, No. 46 / Thursday, March 10, 2005 / Notices announcements can be placed on the Internet more quickly than they can be published in the Federal Register, and FDA believes that the Internet is accessible to more people than the Federal Register. In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the 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 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 this30 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. 11987 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 October 1, 2004, through December 31, 2004. 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, 2004, THROUGH DECEMBER 31, 2004 PMA No./Docket No. Applicant Trade Name Approval Date P020022/2004M–0538 Bayer Healthcare, LLC BAYER VERSANT HCV RNA 3.0 ASSAY (bDNA) March 28, 2003 P020021/2004M–0495 Wilson-Cook Medical, Inc./applicant at approval was Axcan Scandipharm, Inc. WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER August 1, 2003 P040029/2004M–0450 Szabocsik & Associates JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR P030032(S1)/2004M–0467 Genzyme Biosurgery HYLAFORM PLUS (HYLAN B GEL) October 13, 2004 P030011/2004M–0471 Syncardia Systems, Inc. SYNCARDIA TEMPORARY CARDO WEST TOTAL ARTIFICAL HEART (TAH-t) October 15, 2004 P040002/2004M–0533 Endologix, Inc. ENDOLOGIX POWERLINK SYSTEM October 29, 2004 P040022/2004M–0496 Medtronic, Inc./applicant at approval was AngioLink Corp. EVS VASCULAR CLOSURE SYSTEM November 3, 2004 P030031/2004M–0497 Biosense Webster, Inc. BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS November 5, 2004 II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/cdrh/pmapage.html. Dated: March 2, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 05–4763 Filed 3–9–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0069] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the VerDate jul<14>2003 18:28 Mar 09, 2005 Jkt 205001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 September 29, 2004 availability of the guidance document entitled ‘‘Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.’’ This guidance document describes a means by which instrumentation for clinical multiplex test systems may comply with the requirements of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify instrumentation for clinical multiplex test systems into class II (special controls). This guidance document is immediately in effect as the E:\FR\FM\10MRN1.SGM 10MRN1 11988 Federal Register / Vol. 70, No. 46 / Thursday, March 10, 2005 / Notices special control for instrumentation for clinical multiplex test systems, but it remains subject to comment in accordance with the agency’s good guidance practices (GGPs). DATES: Submit written or electronic 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 on a 3.5″ diskette of the guidance document entitled ‘‘Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–443– 8818. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Courtney Harper, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301–594– 1243, ext. 159. SUPPLEMENTARY INFORMATION: I. Background Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying instrumentation for clinical multiplex test systems into class II (special controls) under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This guidance document will serve as the special control for instrumentation for clinical multiplex test systems. Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act (21 U.S.C. 360(k)) for a device that has not previously been classified may, within 30 days after receiving written notice classifying the device in class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written VerDate jul<14>2003 18:28 Mar 09, 2005 Jkt 205001 order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing such classification. Because of the timeframes established by section 513(f)(2) of the act, FDA has determined, under § 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to allow for public participation before issuing this guidance as a final guidance document. Therefore, FDA is issuing this guidance document as a level 1 guidance document that is immediately in effect. FDA will consider any comments that are received in response to this notice to determine whether to amend the guidance document. II. Significance of Guidance This guidance is being issued consistent with FDA’s GGPs regulation (§ 10.115). The guidance represents the agency’s current thinking on instrumentation for clinical multiplex test systems. 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. III. Electronic Access To receive ‘‘Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems’’ by fax, call the CDRH Facts-On-Demand system at 800–899–0381 or 301–827– 0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1546) followed by the pound sign (#). Follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the guidance may also do so by using the Internet. CDRH maintains an entry on the Internet for easy access to information, including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of cleared submissions, approved applications, and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. IV. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501–3520) . The collections of information addressed in the guidance document have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (21 CFR part 807, subpart E, OMB control number 0910–0120). The labeling provisions addressed in the guidance have been approved by OMB under OMB control number 0910–0485. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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. Dated: March 2, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 05–4759 Filed 3–9–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0068] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ‘‘Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System.’’ This E:\FR\FM\10MRN1.SGM 10MRN1

Agencies

[Federal Register Volume 70, Number 46 (Thursday, March 10, 2005)]
[Notices]
[Pages 11987-11988]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4759]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0069]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Instrumentation for 
Clinical Multiplex Test Systems; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance document entitled ``Class II Special 
Controls Guidance Document: Instrumentation for Clinical Multiplex Test 
Systems.'' This guidance document describes a means by which 
instrumentation for clinical multiplex test systems may comply with the 
requirements of special controls for class II devices. It includes 
recommendations for validation of performance characteristics and 
recommendations for product labeling. Elsewhere in this issue of the 
Federal Register, FDA is publishing a final rule to classify 
instrumentation for clinical multiplex test systems into class II 
(special controls). This guidance document is immediately in effect as 
the

[[Page 11988]]

special control for instrumentation for clinical multiplex test 
systems, but it remains subject to comment in accordance with the 
agency's good guidance practices (GGPs).

DATES: Submit written or electronic 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 on a 3.5'' 
diskette of the guidance document entitled ``Class II Special Controls 
Guidance Document: Instrumentation for Clinical Multiplex Test 
Systems'' to the Division of Small Manufacturers, International, and 
Consumer Assistance (HFZ-220), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-443-8818. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to https://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Courtney Harper, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1243, ext. 159.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying instrumentation for clinical multiplex test 
systems into class II (special controls) under section 513(f)(2) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). 
This guidance document will serve as the special control for 
instrumentation for clinical multiplex test systems.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act (21 U.S.C. 
360(k)) for a device that has not previously been classified may, 
within 30 days after receiving written notice classifying the device in 
class III under section 513(f)(1) of the act, request FDA to classify 
the device under the criteria set forth in section 513(a)(1) of the 
act. FDA shall, within 60 days of receiving such a request, classify 
the device by written order. This classification shall be the initial 
classification of the device. Within 30 days after the issuance of an 
order classifying the device, FDA must publish a notice in the Federal 
Register announcing such classification. Because of the timeframes 
established by section 513(f)(2) of the act, FDA has determined, under 
Sec.  10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to 
allow for public participation before issuing this guidance as a final 
guidance document. Therefore, FDA is issuing this guidance document as 
a level 1 guidance document that is immediately in effect. FDA will 
consider any comments that are received in response to this notice to 
determine whether to amend the guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's GGPs regulation 
(Sec.  10.115). The guidance represents the agency's current thinking 
on instrumentation for clinical multiplex test systems. 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.

III. Electronic Access

    To receive ``Class II Special Controls Guidance Document: 
Instrumentation for Clinical Multiplex Test Systems'' by fax, call the 
CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a 
touch-tone telephone. Press 1 to enter the system. At the second voice 
prompt, press 1 to order a document. Enter the document number (1546) 
followed by the pound sign (). Follow the remaining voice 
prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. CDRH maintains an entry on the Internet for 
easy access to information, including text, graphics, and files that 
may be downloaded to a personal computer with Internet access. Updated 
on a regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of cleared submissions, approved applications, and 
manufacturers' addresses), small manufacturer's assistance, information 
on video conferencing and electronic submissions, Mammography Matters, 
and other device-oriented information. The CDRH web site may be 
accessed at https://www.fda.gov/cdrh. A search capability for all CDRH 
guidance documents is available at https://www.fda.gov/cdrh/
guidance.html. Guidance documents are also available on the Division of 
Dockets Management Internet site at https://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520) . 
The collections of information addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the regulations 
governing premarket notification submissions (21 CFR part 807, subpart 
E, OMB control number 0910-0120). The labeling provisions addressed in 
the guidance have been approved by OMB under OMB control number 0910-
0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

    Dated: March 2, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-4759 Filed 3-9-05; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.