Hillebrenner Elaborates on Diagnostics

The Alliance held a webinar with Elizabeth Hillebrenner, CDRH Associate Director for Scientific and Regulatory Programs on Wednesday, February 15.  This educational webinar highlighted FDA’s role in the current regulatory landscape for diagnostics and underscore why regulation in the diagnostics space remains so complicated.  She provided an overview of her responsibilities, explained different kinds of diagnostics, the outlook for the VALID Act, and a number of other topics.

Ms. Hillebrenner said that she works with other parts of the agency, particularly the Commissioner’s Office or other agencies.   She is involved in cross-cutting work, including strategic priorities, implementation of the Moldova 5 agreement, implementation of recommendations from the, independent assessments by OIG, RAO. She also serves in an advisory capacity on some of employee engagement activities, communications, both internal and external.  She has been with CDRH for over 20 years

Per the definition of the Food, Drug, and Cosmetic Act, she said a device is an item intended for use in the diagnosis of diseases or conditions or in the care and mitigation treatment or prevention of disease, with  many different types of devices used for these diagnostic purposes.  Per regulations, she said in-vitro diagnostics are reagents, instruments, and systems used in the collection, preparation, and examination of specimens taken from the human body.  She went on to say that diagnostic technologies have evolved significantly over the past several decades, where pathologists used to look at a patient’s cells under a microscope and know how next-generation sequencing can identify hundreds or more potential genetic variances.

In 1976, FDA was tasked with pre-market review of medical devices through the Medical Device Amendments. At that time laboratory-developed tests or LDTs, were generally simple were made and run in the same lab, and were run in small volumes, with relatively low risk.   LDTs are more widely used today, and the overall risk profile of LDTs has grown. 

Eight years ago, several stakeholders suggested creating a new framework specifically tailored to diagnostics rather than the device framework.   The latest iteration of this framework was called the Verifying Accurate, Leading-edge IVCT Development Act, or VALID Act. It was considered for inclusion in the December omnibus but was not enacted. It would have taken in-vitro diagnostics out of the medical device definition and created a new medical product called in-vitro clinical tests or IBCTs.  LDTs in use today would be grandfathered. FDA could also ask for information to address a specific credible concern when needed. There would be exemptions for low-risk tests, custom and low volume tests, and manual tests. She claimed FDA sees VALID as an important element of preparedness.

When asked if FDA might attempt to implement VALID using existing authorities, she said FDA will move forward with all options on the table.  But they are constrained and there are resource implications.  She also identified the costs to patients who take tests that do not work, and then encounter additional medical expenses. 

Ms. Hillebrenner addressed several additional topics during a question-and-answer period, including:

·       Diagnostics as combination products;

·       Other regulatory authorities that maintain oversight of the performance of LDTs;

·       FDA’s resource needs to implement VALID;

·       Most challenging issues for diagnostics developers;

·       How many tests might exist;

·       Outreach to stakeholders;

·       Opportunities for conversations to clear misunderstandings about VALID; and

·       Resources proposed in VALID.

A transcript of this webinar will be available in a future edition of the Friday update.

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3/2       Dr. Janet Woodcock              3:00     Woodcock event registration

3/23     Dr. Shuren, CDRH                  11:00   Shuren event registration

3/29     Ms. McMeekin, ORA               2:30   McMeekin event registration

3/31     Dr. Mayne, CFSAN                 11:00   Mayne event registration

4/04     Dr. Marks, CBER                      3:30   Marks event registration

4/05     Dr. Cavazzoni, CDER              2:00   Cavazzoni event registration

4/10     Ms. Forfa, CVM                       3:00   Forfa event registration

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