June Update: FDA Guidance Issued
Tuesday, June 23, 2015
Medical Device IDE Draft Guidance
FDA announced the availability of the draft guidance entitled, “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs).” This draft guidance document is intended to provide greater clarity for FDA staff, IDE sponsors, and sponsor-investigators regarding the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical study, and also characterizes benefits in the context of investigational research.
When finalized, the guidance will:
- Enhance the predictability, consistency, and transparency of the IDE review process
- Provide a common understanding between the FDA staff and clinical trials sponsors on what information is critical to the benefit-risk assessment of an IDE submission
- Facilitate the incorporation of evidence and knowledge from different domains—clinical, nonclinical and patient—to support a comprehensive, balanced decision-making approach
Also included in the draft guidance is a proposed framework for benefit-risk assessment that we are recommending IDE sponsors provide as part of their application. The framework outlines a preferred approach for summarizing the key considerations in the benefit-risk assessment for the device. The draft guidance also provides examples of hypothetical assessments to provide additional clarity.
Comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions about this document regarding CDRH-regulated devices, contact the Office of Device Evaluation, Office of the Director, Investigational Device Exemptions (IDE) Staff at 301-796-5640. For questions about this document for CBER-regulated devices, contact the Office of Communication, Outreach and Development at 1-800-335-4709 or 240-402-7800.
FDA Issues Guidance on Naming of Drug Products
FDA’s Center for Drug Evaluation and Research (CDER) announced the availability of a guidance for industry entitled, “Naming of Drug Products Containing Salt Drug Substances.” This guidance document is intended to help sponsors understand how prescription drug products with active ingredients that are salts may be affected by CDER’s implementation of the United States Pharmacopeia (USP) policy entitled, “Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations.”