Fda Medical Device Software Policy

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Policy for Device Software Functions and Mobile Medical …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications

FDA is issuing this guidance to communicate how the Agency intends to apply its regulatory oversight to certain software, including device software functions and mobile medical applications (MMAs ...

Digital Health Policy Navigator | FDA

https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-policy-navigator

The Digital Health Policy Navigator was developed to aggregate the FDA's device digital health guidance documents, including those that interpret the 21st Century …

Device Software Functions Including Mobile Medical …

https://www.fda.gov/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications

The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps. The Policy for …

Software as a Medical Device (SaMD) | FDA

https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd

Changes to Medical Software Policies from Sec3060 of …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/changes-existing-medical-software-policies-resulting-section-3060-21st-century-cures-act

Section 3060(a) of the 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing …

Global Approach to Software as a Medical Device | FDA

https://www.fda.gov/medical-devices/software-medical-device-samd/global-approach-software-medical-device

The FDA issued the Software as a Medical Device: Clinical Evaluation final guidance to describe an internally agreed upon understanding of clinical evaluation and …

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in Software as a Medical Device (SaMD), Interoperability Science and Research CDRH research …

Recognized Consensus Standards - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=38829

Recognized Consensus Standards. IEC 62304:2006+A1:2015 Defines the life cycle requirements for medical device software. The set of processes, activities, and …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.6310

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Subpart G - General Hospital and Personal Use …

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