Technical considerations for medical devices with physiologic closed-loop control technology: guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Devices and Radiological Health (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Equipment Design Equipment Safety Government Regulation Medical Device Legislation Monitoring, Physiologic United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- A physiologic closed-loop controlled (PCLC) device is a system consisting of sensors, actuators, and control algorithms that adjusts or maintains a physiologic variable through automatic adjustments to delivery or removal of energy or article (e.g., drugs, or liquid or gas regulated as a medical device) using feedback from a physiologic-measuring sensor(s). PCLC technology can enable automation in a variety of medical device types. Such devices have the potential to deliver timely, accurate and consistent therapy and can play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care including, for example, during emergency response and medical surge situations. Ensuring patient safety is an important consideration while evaluating the potential benefits of PCLC devices. This document highlights technical considerations for the development of medical devices employing PCLC technology to ensure safe and effective use and provides recommendations for the content of premarket submissions (i.e., premarket notifications (510(k)s), De Novo requests, premarket approval applications (PMAs), Humanitarian Device Exemptions (HDEs)) for such devices. For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” Throughout this guidance, the terms “FDA,” “the Agency,” “we,” and “us” refer to the Food and Drug Administration and the terms “you” and “yours” refer to medical device manufacturers. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (31 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918716783906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918716783906676