Comments

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

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 response to a 2011 request for information, ASHG submitted comments on the Advanced Notice of Proposed Rule Making for “Human Subjects Research Protection: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” The Society proposed adjustments to the review, approval, and follow-up for studies that will facilitate research and improve... Read More

In a 2010 commentary in The American Journal of Human Genetics, an ASHG task force analyzed key scientific and non-scientific aspects of genetic ancestry inference in academia and industry, and provided recommendations to advance discussion and facilitate the development of guidelines concerning the use of these technologies. The commentary built upon a previous statement by... Read More

After GINA’s passage in May 2008, ASHG responded to a Federal Register Request for Information on issues related to the law’s implementation. ASHG provided comment on definitions that would ensure the regulations keep pace with scientific and clinical advances, and clarified that data collected prior to GINA’s passage should still be covered by the law.... Read More