Medical Devices Guidelines

Recent Final Medical Device Guidance Documents | FDA

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-guidance-documents

Jan 12, 2023

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

CDRH 2022 Annual Report. Accomplishments for 2022, including the Pandemic Response, MDUFA V, Device Innovation, over-the-counter (OTC) hearing aid final rule, and device …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling …

Medical Device Safety | FDA

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety. The FDA monitors reports of adverse events and other …

Devices Guidances | FDA - U.S. Food and Drug …

https://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances

Medical devices - World Health Organization

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

Without medical devices, common medical procedures – from bandaging a sprained ankle, to diagnosing HIV/AIDS, implanting an artificial hip or any surgical …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal …

Disinfection & Sterilization Guidelines | Guidelines Library ...

https://www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html

Indications for sterilization and disinfection: by ID number and category. # Recommendation Category; 3.a. Before use on each patient, sterilize critical medical and surgical devices …

Guidance - MDCG endorsed documents and other guidance

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro …

Ultimate List of ISO Standards for Medical Devices

https://www.greenlight.guru/blog/iso-standards

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical …