--- title: US FDA Releases Guidance on Clinical Investigations for Medical Devices description: US FDA Releases Guidance on Clinical Investigations for Medical Devices --- [![](https://www.complianceandrisks.com/wp-content/themes/compliancerisk/inc/img/general/compliancelogo.svg)](https://www.complianceandrisks.com/) - Products Products - - [C2P](https://www.complianceandrisks.com/c2p-compliance-knowledge-management-platform/) - [Regulations Management](https://www.complianceandrisks.com/solutions/conquering-the-regulatory-avalanche/) - [Standards Management](https://www.complianceandrisks.com/solutions/standards/) - [Requirements Management](https://www.complianceandrisks.com/solutions/heres-the-regulation-whats-next/) - [Regulatory Topics](https://www.complianceandrisks.com/solutions/regulated-areas/) - [WFSGI Compliant Labelling Requirements Database](https://www.complianceandrisks.com/WFSGI/) - Services Services - [Market Access Service](https://www.complianceandrisks.com/solutions/grow-in-new-markets/) - [Regulatory Process Consulting](https://www.complianceandrisks.com/solutions/best-practices-in-compliance-processes/) - [Environmental, Health & Safety (EH&S)](https://www.complianceandrisks.com/solutions/ehs-and-your-legal-registers/) - [Managed Services](https://www.complianceandrisks.com/solutions/solutions-for-every-day/) - [Training and Systems Implementation](https://www.complianceandrisks.com/solutions/training-and-systems-implementation/) - [Ask Our Experts](https://www.complianceandrisks.com/solutions/your-compliance-question) - Resources News & Resources - [Blog](https://blog.complianceandrisks.com/news-resources?__hstc=67571022.c37393069837d66fdddfdab74b5ad3c6.1593078357468.1593078357468.1593078357468.1&__hssc=67571022.1.1593078357469&__hsfp=693435645) - [Commentary & Analysis](https://blog.complianceandrisks.com/commentary-analysis?__hstc=67571022.c37393069837d66fdddfdab74b5ad3c6.1593078357468.1593078357468.1593078357468.1&__hssc=67571022.1.1593078357469&__hsfp=693435645) - [COVID-19](https://www.complianceandrisks.com/covid-19/) - [Webinars](https://www.complianceandrisks.com/webinars/) - [White Papers & eBooks](https://www.complianceandrisks.com/whitepapers/) - [About](https://www.complianceandrisks.com/about/) Compliance & Risks - [About Us](https://www.complianceandrisks.com/about/) - [Industries](https://www.complianceandrisks.com/compliance-requirements-industries/) - [History](https://www.complianceandrisks.com/compliance-and-risks-history/) - [Careers](https://www.complianceandrisks.com/compliance-risks-careers/) - [Knowledge Partners](https://www.complianceandrisks.com/knowledge-partners/) - [Partners & Affiliates](https://www.complianceandrisks.com/becoming-a-compliance-risks-partner/) - [Get in touch](https://www.complianceandrisks.com/contact/) COVID-19 Regulatory Developments [Find Out More](https://www.complianceandrisks.com/covid-19/) - [Book a demo](https://www.complianceandrisks.com/book-a-demo/) - [Eng](https://complianceandrisks.com) - [日本語](http://complianceandrisks.jp/) ![](https://www.complianceandrisks.com/wp-content/themes/compliancerisk/inc/img/general/burger.svg) Search for: # US FDA Releases Guidance on Clinical Investigations for Medical Devices --- ##### 07 November 2013 The US Food and Drug Administration (FDA) has released guidelines covering the “Design Considerations for Pivotal Clinical Investigations for Medical Devices.” This document is intended to provide guidance to those involved in designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements. 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