Tarius SAC Tracker®
Background Analysis: US FDA Advisory Committee to Review Strategies to Control Bacterial Contamination of Platelets for Transfusion; Discuss Potential Reclassification of In Vitro HIV Diagnostics – JUL 18-19, 2018 (BPAC)
The US FDA has scheduled a Blood Products Advisory Committee (BPAC) meeting for Wednesday to Thursday, July 18 to 19, 2018. On the first day of the meeting, the Committee will provide advice regarding bacterial risk control strategies to enhance the safety and availability of platelets for transfusion. On the second day of the meeting, the Committee, supplemented with members from the Microbiology Devices Panel of the Medical Devices Advisory Committee, will function as a medical device panel to provide advice and recommendations to the Agency on classification of nucleic acid and serology-based point-of-care and laboratory-based in vitro diagnostic devices indicated for use as aids in the diagnosis of human immunodeficiency virus (HIV) infection.
Background – Bacterial Contamination of Platelets for Transfusion
Bacterial contamination of platelets for transfusion remains a public health concern. Platelets are associated with a higher risk of sepsis and related fatalities than any other transfusable blood component. The Agency issued a March 2016 Draft Guidance document that provided draft recommendations for controlling the risk of bacterial contamination of platelets under 21 CFR 606.145(a). The guidance proposed secondary testing to improve 5-day platelet safety and extended storage to 7 days, and proposed pathogen reduction methods without secondary testing for 5-day platelets. Since the publication of the draft guidance document and receipt of comments, the FDA became aware of additional strategies for bacterial detection that might reduce the risk of bacterial contamination of platelets and potentially permit extension of platelet dating up to 7 days. On this topic, the BPAC met in December 2017, and the Committee voted as follows:
· A majority of the Committee, 16 of 17 members, with no abstentions, voted that the available data support comparability of 5-day storage of apheresis platelets without secondary testing if platelets are cultured no sooner than 24-36 hours post-collection with a sampling volume of at least 3.8% of the collection.
· The Committee voted unanimously (17 of 17 members) that the available data support comparability of the measure to extend dating to Day 7 with culture of apheresis platelets samples no sooner than 36-48 hours after collection using a test volume of at least 16 mL per split without secondary testing.
· A majority of the Committee, 16 of 16 members, with no abstentions, voted that the available data support comparability of the measures to extend dating to Day 7 with repeat culture on Day 4 using a test volume of at least 16 mL per component divided into aerobic and anaerobic tubes without secondary testing. (Note that Dr. Quillin was not available to participate in this vote.)
· The Committee voted unanimously (17 of 17 members) that primary testing of platelets with large volumes should include both an anaerobic and aerobic culture system.
At the upcoming meeting, the Committee will revisit this topic of strategies to control the risk of bacterial contamination of platelets with 5-day and 7-day dating, including consideration of bacterial testing using culture-based devices and rapid bacterial detection devices and implementation of pathogen reduction technology.
Background – In Vitro HIV Diagnostics (IVDs)
The Committee will discuss and provide advice 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 indicated for use as aids in the diagnosis of HIV infection.
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 are not sufficient to establish safety and efficacy, and they:
· Are used in supporting or sustaining life,
· Are for a use that 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 during the meeting are post-amendment devices 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.
Tarius will send a Briefing Summary after briefing materials are posted to FDA’s website (typically within 2 days of the meeting). This report will provide a summary of the FDA and the Sponsor’s 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: devices, blood products Indication: HIV diagnosis, bacterial testing
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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.