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Overview of Device Regulation | FDA
- https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
- In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions....
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 …
Classify Your Medical Device | FDA
- https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
- The three classes and the requirements which apply to them are: Device Class and Regulatory Controls 1. Class I General Controls With Exemptions Without Exemptions 2. …
Overview of Regulatory Requirements: Medical Devices
- https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript
- It basically says a medical device is “any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate, diagnose disease in man”. Some …
Code of Federal Regulations (CFR) | FDA
- https://www.fda.gov/medical-devices/overview-device-regulation/code-federal-regulations-cfr
- Code of Federal Regulations (CFR) FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & Cosmetic Act …
Hospital Equipment Maintenance Requirements | CMS
- https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-14-07
- • The equipment is a medical laser device; or • New equipment without a sufficient amount of maintenance history has been acquired. • Hospitals electing to …
Medical devices - World Health Organization
- https://www.who.int/health-topics/medical-devices
- A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other …
Medical Electrical Equipment Safety and …
- https://talema.com/medical-electrical-equipment-safety-regulation/
- Medical electrical equipment is provided with no more than one connection to a particular mains supply and is intended to: diagnose the patient treat the patient …
Medical Screening and Surveillance - Standards
- https://www.osha.gov/medical-surveillance/standards
- Respiratory protection, medical surveillance, and training requirements under HAZWOPER (September 24, 2002). Access to employee exposure and medical records (June 07, …
What Can I Bring? Medical - Transportation Security …
- https://www.tsa.gov/travel/security-screening/whatcanibring/medical
- Inform the TSA officer if you have a bone growth stimulator, spinal stimulator, neurostimulator, port, feeding tube, insulin pump, ostomy or other medical device …
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