title: Regulation of next generation sequencing.
abstract: Next generation sequencing raises new questions within the context of an existing and still evolving regulatory landscape for device manufacturers and clinical laboratories. FDA cleared the first NGS sequencing platform in November 2013, but it is unclear what lies ahead for this technology. NGS will require new types of training and expertise to interpret the vast quantities of genetic data so as to provide meaningful clinical information to physicians and patients. This paper will describe the current regulatory landscape for NGS technologies, identify the regulatory challenges they present, and consider whether new regulatory paradigms are needed to accommodate NGS technologies and services.
authors.affiliation: Counsel in Sidley's Food and Drug Regulatory practice, where she focuses on FDA regulation of medical devices, biological products, and pharmaceuticals and on regulations of clinical laboratories under CLIA.
authors.forename: Gail H
authors.initials: GH
authors.lastname: Javitt
authors.forename: Katherine Strong
authors.initials: KS
authors.lastname: Carner
mesh_terms: D064790:Clinical Laboratory Services / Q000331:legislation & jurisprudence; D015894:Genome, Human; D033161:Government Regulation; D059014:High-Throughput Nucleotide Sequencing; D006801:Humans; D017422:Sequence Analysis, DNA; D014481:United States; D014486:United States Food and Drug Administration