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Background Analysis: US FDA Advisory Committee to Discuss Device Reclassification of HIV and HCV Diagnostics; Hear Research Updates


The US FDA has scheduled a joint meeting of the Blood Products Advisory Committee (BPAC) and the Microbiology Devices Panel of the Medical Devices Advisory Committee for Wednesday to Thursday, March 21-22, 2018. The Committee will discuss and make recommendations about reclassification of certain Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) diagnostics In addition, the Committee will hear presentations about research programs from laboratories in the Office of Blood Research and Review within the Center for Biologics Evaluation and Research (CBER)..


During the morning session on March 21, 2018, the Joint Committee will discuss and make recommendations regarding the device reclassification from Class III to Class II of nucleic acid and serology-based point-of-care and laboratory-based in vitro diagnostic devices (IVDs) indicated for use as aids in the diagnosis of HIV infection.

In the afternoon session, the Committee will hear presentations on the research programs of the Laboratory of Emerging Pathogens, the Laboratory of Bacterial and Transmissible Spongiform Encephalopathy Agents, and the Laboratory of Molecular Virology in the Division of Emerging Transfusion-Transmitted Diseases, Office of Blood Research and Review, within the Center for Biologics Evaluation and Research (CBER).

After the open session, from 4:40 p. to 5:15 pm, the meeting will be closed to the public to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6).

On March 22, 2018, the Joint Committee will discuss and make recommendations regarding the reclassification from Class III to Class II of nucleic acid and serology-based IVDs indicated for use as aids in diagnosis of HCV infection and/or for use as aids in the management of HCV infected patients.

Regulatory Background

In Vitro Diagnostic (IVD) Classification

IVDs are classified into one of three classes by the US FDA, the same as other medical devices, based on the potential risk associated with the use of the device.

Class I devices are subject to the least regulatory control. Several IVDs are Class I devices, e.g., positive/negative-result pregnancy tests and most reproductive hormone tests.

Class II devices are those devices for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide assurance of safety and effectiveness. Most IVDs are Class II devices.

Class III devices are those devices for which general and special controls alone is not sufficient to establish safety and efficacy, and they:

·      Are used in supporting or sustaining life,

·      Are for a use which is of substantial importance in preventing impairment of human health, or

·      Present a potential unreasonable risk of illness or injury.

Postamendment Device Reclassification

The devices that will be discussed by the Committee are post-amendment IVDs that currently are classified into Class III under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)). A postamendment device is a type of medical device that was not in commercial distribution prior to May 28, 1976, with no substantially equivalent preamendment device (medical devices that were in commercial distribution before May 28, 1976) predicate, and that has not been previously classified or reclassified. All such device types are automatically classified under Section 513(f)(1) into Class III without any FDA rulemaking process. These devices remain in Class III and require premarket approval (PMA), unless and until the device is classified through the de novo process under 513(f)(2) of the FD&C Act, reclassified into Class I or II, or the FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval (PMA).

Under Section 513(f)(3), for a postamendment device classified into Class III under Section 513(f)(1), the FDA may initiate a reclassification or respond to a petition from an interested person who requests reclassification of the device type to either Class I or II. In addition to the 513(e) reclassification activities described above, in order to change the classification of the device type, the device must meet the definition of devices that belong in that class. If FDA receives a petition requesting a reclassification, the FDA reviews the petition for any deficiencies that prevent the FDA from making a decision on it. If the FDA determines that the petition contains no such deficiencies, the FDA may, for good cause, refer the petition to an appropriate device classification panel to review the information and make a recommendation on the petition. Once the information has been considered, the FDA will approve or deny the petition. If the FDA approves the petition, an order will be issued describing the reasons for approving the petition and identify the risks to health, if any, presented by the device to which the order applies.

What’s Next?

Tarius will send a Briefing Summary after briefing materials are posted to the FDA’s website (typically within 2 days of the meeting). This report will provide a summary of the FDA and the Sponsor’s (if applicable) briefing materials.

Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.

METADATA: Sponsor: none Drug Name: none Drug Class: HIV and HCV diagnostics Indication: diagnosis of HIV and HCV

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DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.