Regulatory Preparedness Medical Devices

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 - World Health Organization

https://www.who.int/health-topics/medical-devices

In order to increase access to appropriate, safe, affordable, effective medical devices of quality for all; the WHO Medical Devices has enable the WHO Global Fora …

The Role of Regulatory Affairs in the Medical Device …

https://www.northeastern.edu/graduate/blog/regulatory-affairs-in-medical-device-industry/

Regulatory Controls | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls

General controls are regulatory requirements authorized by the FD&C Act, under sections 501, 502, 510, 516, 518, 519, and 520. General controls apply to all medical devices, …

Emergency Preparedness Program: Research on …

https://www.fda.gov/medical-devices/medical-device-regulatory-science-research-programs-conducted-osel/emergency-preparedness-program-research-medical-devices-emergencies

The Emergency Preparedness Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure …

Quality System (QS) Regulation/Medical Device Good …

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

The QS regulation applies to finished device manufacturers who intend to commercially distribute medical devices. A finished device is defined in 21 CFR 820.3 (l) …

Overview of Regulatory Requirements: Medical Devices

https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript

Currently, in the Code of Federal Regulations, there are about 1700 devices that have been classified by the FDA. They can be found in 16 medical specialties or device …

Medical Device Regulatory Changes Occurring in 3 Key …

https://www.certara.com/blog/medical-device-regulatory-changes-geographics/

Class C devices have until May 2026. Class B and Class A Sterile devices have until May 2027. Class A Non-Sterile devices are under IVDR regulations as of …

Managing Regulatory Intelligence for …

https://www.raps.org/news-and-articles/news-articles/2019/1/managing-regulatory-intelligence-for-medical-devic

In the last 10 to 15 years, FDA also has implemented a number of regulations for medical devices, including one of the major and most recent ones, the …

6 Regulatory Pathways to Bring Your …

https://blog.sierralabs.com/6-regulatory-pathways-to-bring-your-medical-device-to-market

Here are the 6 Regulatory Pathways for Medical Devices: Pre-Market Notification 510 (K) Pre-Market Approval (PMA) Product Development Protocol (PDP) De Novo …