Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.” This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to classify in vitro diagnostic devices for Bacillus spp. detection into class II, subject to special controls. This draft guidance is not final nor is it in effect at this time.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 16, 2011.

ADDRESSES:

Submit written requests for single copies of the draft guidance document entitled “Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection” 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. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit electronic comments on the draft guidance to http://www.regulations.gov.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:

Beena Puri, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5553, Silver Spring, MD 20993-0002, 301-796-6202.

SUPPLEMENTARY INFORMATION:

I. Background

This draft special controls guidance document was developed to support the proposed classification of in vitro diagnostic devices for Bacillus spp. detection, a previously unclassified preamendments device, into class II (special controls). On March 7, 2002, the Microbiology Devices Panel (the Panel) recommended that in vitro diagnostic devices for Bacillus spp. detection be classified into class II. The Panel believed that class II with the special controls (guidance document and limitations on the distribution) would provide reasonable assurance of the safety and effectiveness of the device.

After the panel meeting, FDA found three additional in vitro diagnostic devices for Bacillus spp. detection to be substantially equivalent to another device within that type. This device has the same intended use as its predicate device but makes use of newer nucleic acid amplification technology (NAAT). While NAAT detection devices exhibit technological differences from the preamendments Bacillus spp. detection devices, FDA has determined that they are as safe and effective as, and do not raise different questions of safety and effectiveness than, their predicates. (See section 513(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i)).)

This draft guidance document identifies the proposed classification regulation and product code and issues of safety and effectiveness that require special controls. Elsewhere in this Federal Register, in its publication of the proposed classification regulation, FDA is including proposed distribution limitations as another special control. FDA believes that the special controls described in the draft guidance and the proposed regulation when combined with general controls will be sufficient to provide reasonable assurance of the safety and effectiveness of these devices.

II. Significance of Special Controls Guidance Document

FDA believes that adherence to the recommendations described in this guidance document, if finalized, in addition to general controls, and the special control in the proposed rule, if finalized, will provide reasonable assurance of the safety and effectiveness of in vitro diagnostic devices for Bacillus spp. detection classified under § 866.3045 (21 CFR 866.3045). If classified as a class II device under § 866.3045, an in vitro diagnostic device for Bacillus spp. detection will need to comply with the requirement for special controls; manufacturers will need to address the issues requiring special controls as identified in the guidance document or by some other means that provides equivalent assurances of safety and effectiveness as well as comply with any additional controls specified in the classification regulation itself.

III. Electronic Access

Persons interested in obtaining a copy of the draft 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 “Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection,” you may either send an e-mail 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 1667 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This draft guidance 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 (the PRA) (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, and 21 CFR 809.10 have been approved under OMB control number 0910-0485.

The labeling requirement listed in Section 8A, “Intended Use,” is not subject to review under the PRA because it is a public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public (5 CFR 1320.3(c)(2) and 21 CFR 1040.10(g)).

V. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES), either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed 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.