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FDA Comes Through on Promise to Release NGS Device Draft Guidelines Expeditiously

Building on last year’s public workshops related to Next-Generation Sequencing (NGS) and expanding its efforts to advance the Obama Administration’s Precision Medicine Initiative, late last week, FDA released two draft guidance documents on different aspects of NGS-based diagnostic tests. NGS is a term used to describe new technologies that allow rapid sequencing of large segments of an individual’s DNA or entire genomes, as we have described previously.  The Agency’s stated goal is “to create a flexible and adaptive regulatory approach to the oversight of NGS-based tests,” given the rapid and innovative advancements being made in the technologies.

Of the two new policies, the first draft guidance describes an approach to allow test developers to rely on clinical evidence from FDA-recognized public genome databases to support claims for their tests and to provide assurance of accurate clinical interpretation of genomic test results, potentially offering a streamlined path to approval. The second document provides recommendations for designing, developing and validating NGS-based tests for rare hereditary diseases and addresses the potential for using FDA-recognized standards to show analytical validity. For a more in-depth look at each guidance document, please see our full client alert.

Perhaps what is most telling in the draft guidance documents is what is missing or what is specifically carved out. Neither addresses how these policies will intersect with FDA plans for laboratory developed tests (LDTs).  Although we previously described FDA’s plans for a final LDT policy in early 2016, nothing has been finalized to date. Certainly there will be an intersection because the FDA policy set forth in these two guidance documents specifically focuses on the recommendations for preparing a premarket submission, leaving open the specific question of when enforcement discretion will be exercised, if at all, for NGS-based tests.

We will be posting further analysis and commentary on these proposed policies, and we plan to provide recommendations to potentially affected stakeholders who may want to submit their feedback to FDA. Public comments on these two NGS draft guidances are being accepted until October 6, 2016.  A list of specific questions from the Agency to interested parties about the policies and regulatory approaches laid out in each document can be viewed in the July 8 Federal Register notices of availability – available here for “Use of Databases” and here for “Use of Standards.”

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Joanne S. Hawana counsels global Mintz clients on regulatory and distribution-related considerations for new FDA-regulated products. She also advises clients on the business impacts of new federal and state actions on food, drugs, cosmetics, electronic nicotine systems, and medical devices.