SUPPLEMENTARY INFORMATION:

I. Background

This guidance document provides industry and Agency staff with FDA's current thinking on regulation of molecular diagnostic instruments that combine in a single instrument both approved/cleared device functions and device functions for which approval/clearance is not required, and on the type of information that FDA recommends that applicants include in a submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions. Molecular diagnostic instruments, for example, real-time thermocyclers, are critical components of certain in vitro diagnostic devices. They are often used to perform multiple unrelated assays, such as those that detect methicillin resistant Staphylococcus aureus, hepatitis C virus, and genetic markers of cystic fibrosis. These types of instruments cannot generally be approved/cleared alone, i.e., without an accompanying assay, because their safety and effectiveness cannot be evaluated without reference to the assays that they run and their defined performance parameters. However, the same instruments may also be used for additional purposes that do not require FDA approval or clearance, such as for basic scientific research. In the past, FDA has provided informal advice in response to individual inquiries regarding the permissibility of having functions for which approval/clearance is not required on an instrument intended to be used with approved/cleared in vitro diagnostic assays. This guidance is meant to communicate FDA's policy regarding molecular diagnostic instruments with combined functions.

This guidance applies to molecular diagnostic instruments that are medical devices used with assays that measure or characterize nucleic acid analytes, human or microbial, and that combine both approved/cleared and non-approved/non-cleared functions in a single instrument. This guidance applies to the instrument itself (hardware) as well as to any firmware or software intended to operate on or to control the instrument. This guidance also addresses software that is distributed as a stand alone device for use with an approved/cleared molecular diagnostic assay.

The guidance does not apply to instruments approved/cleared for use with assays that are intended to screen donors of blood and blood components, human cells, tissues, and cellular and tissue-based products, for communicable diseases. The document also does not apply to instruments approved/cleared for blood grouping. We encourage manufacturers wishing to market such instruments with combined functionality to contact the appropriate office in the Center for Biologics Evaluation and Research (CBER).

The recommendations in this guidance do not apply to assays and reagents. They are also not intended to change FDA's position regarding the marketing of Research Use Only and Investigational Use Only assays for clinical use.

The draft guidance was announced in the Federal Register of April 9, 2013 (78 FR 21128), and the comment period closed on July 8, 2013. Several comments were received during the comment period. We took the suggestions into consideration in revising and finalizing this guidance.

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 molecular diagnostic instruments with combined functions. 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

Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm. Guidance documents are also available at http://www.regulations.gov or from ( printed page 67176) CBER at http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​default.htm. Persons unable to download an electronic copy of “Molecular Diagnostic Instruments With Combined Functions” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1763 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This 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 (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; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910-0437; and the collections of information in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control number 0910-0485.

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.