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Medical Device Knowledgebase

FDA's MDR and General Recall Questions

• What enforcement or administrative actions can the FDA take is a manufacturer is in violation of their laws?

• How has the Human Factors (HF) changed through time?

• Under Medical Device Reporting (MDR) is a manufacturer responsible for notifying the FDA if the incident occurred overseas?

• Does the FDA give you a chance to state your case before initiating report of Criminal Violation?

• What is a “Recall Strategy” as defined by the FDA?

• What is a “recall” as defined by the FDA?

• What is a Medical Device “Stock Recall” as defined by the FDA? 

• What is a Medical Device “Market Withdrawal” as defined by the FDA?

• What are some of the actions that a manufacturer can take to correct a problem with a medical device on the market?

• What is a Medical Device “Correction” as defined by the FDA?

• Do you need to wait for the FDA to approve your Recall Strategy before beginning the recall?

• What does the FDA expect to see in your Health Hazard evaluation (HHE)?

• Who assigns the classification of a recall (Class I, II or III)?

• What are the different recall classifications and how are they defined?