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CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.415
- (1) In such a manner that it generates ozone at a level in excess of 0.05 part per million by volume of air circulating through the device or causes an accumulation of ozone in excess of 0.05 part...
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=172&showFR=1
- (4) Heavy metals as lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. (c) …
Safety of Metals and Other Materials Used in Medical …
- https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices
- The FDA accepted feedback through August 18, 2021 in a public docket FDA-2021-N-0334 . Numerous types of materials, including metals, polymers and …
FDA Issues Recommendations for Certain High-Risk …
- https://www.fda.gov/news-events/press-announcements/fda-issues-recommendations-certain-high-risk-groups-regarding-mercury-containing-dental-amalgam
- The FDA has found that certain groups may be at greater risk for potential harmful health effects of mercury vapor released from the device.
Medical Device Safety | FDA - U.S. Food and Drug …
- https://www.fda.gov/medical-devices/medical-device-safety
- Medical Device Safety | FDA Medical Device Safety The FDA monitors reports …
Dental Amalgam Recommendations for Certain High …
- https://www.fda.gov/medical-devices/safety-communications/recommendations-about-use-dental-amalgam-certain-high-risk-populations-fda-safety-communication
- The U.S. Food and Drug Administration (FDA) is providing recommendations about the use of dental amalgam in certain groups of people who may be at greater risk …
Class I and Class II Device Exemptions | FDA
- https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions
- A device may be exempt from 510 (k) requirements if the FDA determines that a 510 (k) is not required to provide reasonable assurance of safety and effectiveness …
Mercury and Methylmercury | FDA
- https://www.fda.gov/food/metals-and-your-food/mercury-and-methylmercury
- FDA/EPA Advice and Questions & Answers Quantitative Assessment of the Net Effects on Fetal Neurodevelopment from the Eating Commercial Fish (As Measured by IQ and also …
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 …
External Penile Rigidity Devices Special Controls Guidance
- https://www.fda.gov/medical-devices/external-penile-rigidity-devices-class-ii-special-controls-guidance-document-industry-and-fda-staff
- The Food and Drug Administration (FDA) is designating this guidance as a special control guidance for external penile rigidity devices and is exempting this device from the …
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