Testing Oversight

Two new FDA guidances on next generation sequencing-based tests aim to spur innovation in these tests and streamline their regulatory review. Read More

In 2018, the U.S. Food and Drug Administration (FDA) invited comments on its intention to exempt a list of class II devices from premarket notification requirements, including tests assessing genetic health risks. ASHG responded to this request for comment by outlining its support for regulation that brings scientifically valid, evidence-based tests to market, and expressing... Read More

Many geneticists are unfamiliar with the FDA's investigational device exemption regulation and its relevance for genomics research. Read More

In 2015 and 2016, ASHG submitted comments to the U.S. Food and Drug Administration (FDA) on two related proposed regulations for Next Generation Sequencing (NGS)-based in vitro diagnostics. Appreciative of being engaged in the process, ASHG submitted comments to further inform and clarify the issue. Related: Comments on “Use of Standards in FDA Regulatory Oversight... Read More

In 2015, the U.S. Food and Drug Administration (FDA) invited comment on its draft guidance for the regulatory oversight of laboratory-developed tests (LDTs). With a focus on genetic and genomic testing, ASHG submitted comments on the proposed regulatory oversight of such tests. Related: Comments Submitted in Response to FDA’s Draft Guidance: Framework for Regulatory Oversight... Read More