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Preparation of 510(k) Applications for Exercise …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-document-preparation-premarket-notification-510k-applications-exercise-equipment
- Intended UseIdentify the specific intended use(s), including the specific diagnostic and/or th…Device Description1. Provide a written device description (e.g., mechanical, electrical, mate… See more
Recent Final Medical Device Guidance Documents | FDA
- https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-guidance-documents
- Jan 12, 2023
GUIDANCE DOCUMENT FOR THE …
- https://www.fda.gov/media/72390/download
- If your device uses controlling software, you should refer to the FDA document entitled"Reviewer Guidance for Computer Controlled Medical Devices Undergoing …
CDRH Final Guidance 2-Page Cover Sheet …
- https://www.fda.gov/media/72617/download
- Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review (August 29, 1991) ODE Guidance for the Content of Premarket Submission Containing …
Guidance for Industry - COMPUTERIZED SYSTEMS …
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/guidance-industry-computerized-systems-used-clinical-trials
- Computerized systems should be designed: (1) So that all requirements assigned to these systems in a study protocol are satisfied (e.g., data are recorded in metric units, …
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
- Act as wireless remote controls or synchronization devices for computed tomography (CT) or X-Ray machines. Possible product code: JAK (21 CFR 892.1750), …
Reviewer Guidance for Computer Controlled Medical …
- https://books.google.com/books/about/Reviewer_Guidance_for_Computer_Controlle.html?id=cO81GwAACAAJ
- Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510 (k) Review Center for Devices and Radiological Health (U.S.). Office of Device Evaluation …
Reviewer Guidance For Computer Controlled Medical Devices
- https://dayofdifference.org.au/r-medical/reviewer-guidance-for-computer-controlled-medical-devices.html
- Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review. Center for Devices and Radiological Health (U.S.). Office of Device Evaluation. Federal …
Guidance on the Content of Premarket Notification …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-notification-510k-submissions-clinical-electronic-thermometers
- Provide the following information for the device. The applicant may refer to relevant standards. a. Physical Specifications (1) Components: Identify and describe all major …
Reviewer Guidance for Nebulizers, Metered Dose …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reviewer-guidance-nebulizers-metered-dose-inhalers-spacers-and-actuators
- This reviewer guidance document suggests the importance of environmental testing, performance evaluations, and labeling information for aerosol delivery devices. It is …
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