Department of Health and Human Services August 31, 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 6 of 6
Electronic Study Data Submission; Data Standards; Support for Version Update of the Medical Dictionary for Regulatory Activities
The Food and Drug Administration (FDA or Agency) is announcing support for the most current version of Medical Dictionary for Regulatory Activities (MedDRA), end of support for earlier versions of MedDRA, and an update to the FDA Data Standards Catalog (Catalog) for study data provided in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
Policy Clarification and Premarket Notification (510(k)) Submissions for Ultrasonic Diathermy Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy DevicesDraft Guidance for Industry and Food and Drug Administration Staff.'' When final, this draft guidance will clarify FDA's policy related to compliance with applicable performance standards and conformance to International Electrotechnical Commission (IEC) consensus standards for ultrasonic diathermy devices. This draft guidance will also provide recommendations for information to provide in 510(k) submissions for ultrasonic diathermy devices. This draft guidance is not final nor is it in effect at this time.
Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.'' FDA is issuing this guidance to clarify how we evaluate real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices. The guidance describes the circumstances when real-world evidence can be used, and the scientific criteria that must be fulfilled in order to have confidence in the data. Finally, the guidance describes some examples of actual uses of real-world evidence that have already led to FDA decisions.
Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry; Availability
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.'' This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk- based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' The newly available draft chapter is entitled ``Chapter SixUse of Heat Treatments as a Process Control.''
Peer Review of Draft NTP Approach to Genomic Dose-Response Modeling; Availability of Documents; Request for Comments; Notice of Expert Panel Meeting
The National Toxicology Program (NTP) announces an expert panel meeting and is obtaining comment on a proposed approach to genomic dose-response modeling. Prior to the expert panel meeting, NTP will host four webinars that present other approaches to genomic dose- response modeling. The expert panel meeting and four webinar presentations leading up to the meeting are open to the public. Registration is requested for both in-person meeting attendance and oral comment; registration is required to access the meeting webcast. URLs for live and archived pre-meeting webinars will be available at https://ntp.niehs.nih.gov/about/org/ntpexpertpanel/.
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