|
Canada-0-ABRASIVES ไดเรกทอรีที่ บริษัท
|
ข่าว บริษัท :
- Products and Medical Procedures | FDA
General Hospital Devices and Supplies Devices used by health care professionals to support patient care, such as hospital beds, infusion pumps, medical device connectors, medical device data
- How to Determine if Your Product is a Medical Device | FDA
The FDA considers a product to be a device, and subject to FDA regulation, if it meets the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act
- Overview of Device Regulation | FDA
Device Advice Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling and reporting requirements
- Coronavirus (COVID-19) and Medical Devices | FDA
Medical devices used to diagnose or treat COVID-19 include diagnostic tests, masks, gowns, gloves, sterilizers, and ventilators
- Classify Your Medical Device | FDA
Medical devices are assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device The three classes are: Class I
- Medical Device Reporting (MDR): How to Report Medical Device Problems
Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk
- Safety of Metals and Other Materials Used in Medical Devices
On May 20, 2021, the FDA published a discussion paper, Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework, intended to
- Device Approvals and Clearances | FDA
A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that
- An Introduction to FDA’s Regulation of Medical Devices
Medical Device, defined • Instrument, apparatus, machine, implant, in vitro reagent, including component, part, or accessory • Diagnoses, cures, mitigates, treats
- Medical Device Supply Chain Vulnerabilities and the Public Health . . .
Hospitals struggled to procure basic equipment like ventilators and personal protective equipment These medical devices are specifically used for life-saving procedures in neonates and
|
|