Explain FDA's role in regulating medical devices. • Define a medical device and review basics about device classification. • Describe five steps to get a ...

Guidance documents are prepared for the FDA's staff, regulated industry, and the public to describe the FDA's interpretation of or policy on a regulatory issue.

4 янв. 2023 г. · This report describes (1) FDA's authority to regulate medical devices; (2) medical device classification panels and regulatory classes; (3) ...

This publication explains label and labeling regulations and requirements for medical devices. The Food and Drug Administration has many labellfig-related.

This list contains the most recent final medical device guidance documents. For a complete listing, please see the Guidance Documents homepage.

This guidance document does not address medical devices subject to licensure as a biological product. Please direct questions concerning those devices to ...

1. Establish guidelines for manufacturers of home use devices;. 2. Develop a home use device labeling repository;. 3. Partner with home health accrediting ...

14 сент. 2016 г. · Under the Federal Food, Drug, and Cosmetic Act (FFDCA), all medical device manufacturers must register their facilities and list their devices ...

8 нояб. 2016 г. · This guidance document describes and explains the Food and Drug Administration's. (FDA, we, us) current regulation that addresses reporting and ...

12 мая 2016 г. · FDA has determined that certain types of medical devices are exempt from GMP requirements. – These devices are exempted by FDA ...