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What are examples of Software as a Medical Device? | FDA
- https://www.fda.gov/medical-devices/software-medical-device-samd/what-are-examples-software-medical-device
- Software as a Medical Device may be interfaced with other medical devices, including hardware medical devices, and other software as a medical device software, as well as general...
Content of Premarket Submissions for Software …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices
- Center for Devices and Radiological Health This guidance document is intended to provide information to industry regarding the documentation that we recommend you include in …
Examples of Device Software Functions the FDA Regulates
- https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-device-software-functions-fda-regulates
- Software functions that are used in active patient monitoring or to analyze patient-specific medical device data and therefore are the focus of the FDA's regulatory …
FDA Issues Draft Guidance for Software Contained in Medical …
- https://www.jdsupra.com/legalnews/fda-issues-draft-guidance-for-software-1347381/
- The draft guidance is intended to cover: firmware and other means for software-based control of medical devices, stand-alone software applications, …
Guidance for the Content of Premarket Submissions …
- https://www.fda.gov/files/medical%20devices/published/Guidance-for-the-Content-of-Premarket-Submissions-for-Software-Contained-in-Medical-Devices---Guidance-for-Industry-and-FDA-Staff.pdf
- accessories to medical devices when those accessories contain or are composed of software. This guidance applies to software devices regardless of the …
FDA Issues Draft Guidance for Software Contained in Medical …
- https://knobbemedical.com/medicaldeviceblog/article/fda-issues-draft-guidance-for-software-contained-in-medical-devices/
- The draft guidance pertains to software in a medical device (“SiMD”) and software as a medical device (“SaMD”). The Regulatory Affairs Professional Society …
Premarket Submissions - Cybersecurity in Medical …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-management-cybersecurity-medical-devices
- The need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network- …
Content of Premarket Submissions for Device Software …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions
- 2 See FDA website on " Software as a Medical Device (SaMD) ." 3 As a reminder, manufacturers of device software must create and maintain software-related …
510 (K) Submission for Software-Contained Medical Devices
- https://emmainternational.com/510k-submission-software-contained-medical-devices/
- According to the FDA guidance ‘ Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices’ the content of your pre …
Content of Premarket Submissions for Software …
- https://cacmap.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices
- Center for Devices and Radiological Health This guidance document is intended to provide information to industry regarding the documentation that we recommend you include in …
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