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How to Determine if Your Product is a Medical Device | FDA
- https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
- Is your product a Device Software Function?The FDA refers to software functions that are device functions as “device softw…What to do if your product is not a medical deviceIf your product does not meet the definition of a medical device, it may … See more
Medical Devices | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/Medical-Devices
- Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …
Overview of Regulatory Requirements: Medical Devices
- https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript
- FDA has classified all medical devices into either Class I, II, and III. Currently, in the Code of Federal Regulations, there are about 1700 devices that have been classified by the …
Remanufacturing and Servicing Medical Devices | FDA
- https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/remanufacturing-and-servicing-medical-devices
- Servicing is the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.3
- (p) Manufacturing material means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=803.3
- (i) Hospital means a distinct entity that operates for the primary purpose of providing diagnostic, therapeutic (such as medical, occupational, speech, …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.72
- (a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=211.67
- (a) Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals …
Equipment | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/equipment
- (a) Equipment shall be adequately inspected, cleaned, and maintained. Equipment used for the generation, measurement, or assessment of data shall be adequately tested, …
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