Clinical OMICs - Volume 3, Issue 9 - 16
FDA Seeks Methods
to Better Regulate
NGS Products
Jeffrey N. Gibbs
N
ext generation sequencing (NGS) is playing an increasingly important role in clinical research and clinical diagnostics. This expanding
utilization has largely occurred outside of the U.S. Food and Drug Administration's (FDA's) regulatory process. In part, this is due to the lack of
clear regulatory guidance as to how tests using NGS would undergo regulatory review; NGS-based tests do not neatly fit within the current regulatory model. The lack of clarity makes it difficult for FDA to articulate
expectations, and deters companies from submitting applications. Unclear
regulatory requirements and pathways make the review process more unpredictable and risky for applicants.
Another thorny issue is product change. While in vitro diagnostic (IVD) tests tend
to change over time, NGS tests are far more elastic. Obtaining clearance for an NGS
product that is static, e.g., cannot be updated to reflect new data or genetic insights, is
not commercially viable. To FDA's credit, the agency has been working for a number of
years to develop clearer guidance on NGS assays, and has solicited substantial public
input. On July 8, FDA released two draft guidances. One addresses the acceptability of
curated data bases, and the other data requirements for IVDs for germline mutations. Both
JEFFREY N. GIBBS
documents are important not only for their
is Director of Hyman, Phelps & McNamara, P.C.
(jgibbs@hpm.com)
impact on NGS tests, but also the insights they
offer into FDA regulation of other kinds of IVDs.
16
Clinical OMICs September 2016
www.clinicalomics.com
http://www.clinicalomics.com
Table of Contents for the Digital Edition of Clinical OMICs - Volume 3, Issue 9
Contents
Clinical OMICs - Volume 3, Issue 9 - Cover1
Clinical OMICs - Volume 3, Issue 9 - Cover2
Clinical OMICs - Volume 3, Issue 9 - Contents
Clinical OMICs - Volume 3, Issue 9 - 4
Clinical OMICs - Volume 3, Issue 9 - 5
Clinical OMICs - Volume 3, Issue 9 - 6
Clinical OMICs - Volume 3, Issue 9 - 7
Clinical OMICs - Volume 3, Issue 9 - 8
Clinical OMICs - Volume 3, Issue 9 - 9
Clinical OMICs - Volume 3, Issue 9 - 10
Clinical OMICs - Volume 3, Issue 9 - 11
Clinical OMICs - Volume 3, Issue 9 - 12
Clinical OMICs - Volume 3, Issue 9 - 13
Clinical OMICs - Volume 3, Issue 9 - 14
Clinical OMICs - Volume 3, Issue 9 - 15
Clinical OMICs - Volume 3, Issue 9 - 16
Clinical OMICs - Volume 3, Issue 9 - 17
Clinical OMICs - Volume 3, Issue 9 - 18
Clinical OMICs - Volume 3, Issue 9 - 19
Clinical OMICs - Volume 3, Issue 9 - 20
Clinical OMICs - Volume 3, Issue 9 - 21
Clinical OMICs - Volume 3, Issue 9 - 22
Clinical OMICs - Volume 3, Issue 9 - 23
Clinical OMICs - Volume 3, Issue 9 - 24
Clinical OMICs - Volume 3, Issue 9 - 25
Clinical OMICs - Volume 3, Issue 9 - 26
Clinical OMICs - Volume 3, Issue 9 - 27
Clinical OMICs - Volume 3, Issue 9 - 28
Clinical OMICs - Volume 3, Issue 9 - 29
Clinical OMICs - Volume 3, Issue 9 - 30
Clinical OMICs - Volume 3, Issue 9 - 31
Clinical OMICs - Volume 3, Issue 9 - 32
Clinical OMICs - Volume 3, Issue 9 - 33
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