FDA Advisory Committee on Microbiology Devices on HBV Assays
September 7, 2023
I am Dr. Diana Zuckerman, president of the National Center for Health Research. Our nonprofit public health think tank was founded in 1999 and we focus on the safety and effectiveness of medical products. We do not accept funding from companies that make the products that we evaluate so I have no conflicts of interest.
My expertise is in epidemiology and public health and I previously was a researcher at Harvard and Yale and a Congressional investigator in the U.S. House of Representatives and Senate evaluating the impact of FDA policies. I’ve published numerous articles regarding the impact of FDA policies and I am a founding board member of the Alliance for a Stronger FDA, a coalition of industry and nonprofits that works to ensure sufficient resources for FDA to support its very important work.
I want to thank all of you for your important work today.
I will speak briefly this morning about your goals at this meeting.
These assays have been designated as high risk Class III devices that patients depend on for accuracy – sensitivity and specificity. I have conducted numerous studies on device recalls, and have found that Class II devices are much more likely to be recalled than Class III devices, because the standards for getting them on the market is much lower. In fact, the FDA does not refer to Class II devices as approved – they are referred to as cleared for market. There is a good reason for that distinction and that is what concerns me today.
I am not an expert on the assays being discussed today but I have spoken with experts from medical schools and the NIH and learned that — as you’ve already heard today — good HBV assays already exist, so what is the need for changing the category to Class II? Lowering the standards in an effort to get them to market more quickly without the data needed to know how accurate they are is potentially very harmful to patients – either false positives or false negatives would result in inappropriate treatment. You’ve already heard this morning about the importance of accuracy in sensitivity and specificity.
These assays are very important and will have an enormous impact on treatment decisions for patients. Inaccurate results will result in inappropriate treatment decisions. Special controls for Class II devices will be helpful, but will not result in the higher standards required for Class III devices.
These are the 3 types of products that would have lower standards:
- Qualitative HBV antigen assays, qualitative HBV antibody assays, quantitative assays that detect anti-HBs [antibodies to HBV surface antigen (HBsAg)], quantitative HBV molecular assays, hereafter referred to as HBV assays,
- Qualitative parvovirus B19V antibody assays, and
- Qualitative Mycobacterium tuberculosis (TB) cell mediated immune reactivity/Interferon Gamma Release Assays (IGRA).
I respectfully urge this Advisory Committee to consider how lowering the standards could have a harmful impact on patients.
Thank you for the opportunity to speak to you today.