Additional information and resources for the Orange Book| www.accessdata.fda.gov
Note: The revision of this Import Alert (IA) dated 03/01/2023 updates the import alert name to include the country of China. Additional updates are also made to the reason for alert section, the guidance section, product description, and countries section. Changes to the import alert are bracketed by asterisks (***).| www.accessdata.fda.gov
Keyword Search allows you to search and retrieve narrowed search results based on the predefined search criteria fields.| www.accessdata.fda.gov
Note: The revision of this Import Alert (IA) dated 04/12/2024 updates the IA name, reason for alert, guidance section including agency contacts and countries section. Changes to the import alert are bracketed by asterisks (***).| www.accessdata.fda.gov
The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last ten years. Reports older than ten years are provided on the FDA's MDR Data Files webpage. | www.accessdata.fda.gov
Links on this page:| www.accessdata.fda.gov
Links on this page:| www.accessdata.fda.gov
Keyword Search allows you to search and retrieve narrowed search results based on the predefined search criteria fields.| www.accessdata.fda.gov
Select a Report:| www.accessdata.fda.gov
The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.| www.accessdata.fda.gov
Note: The revision of this Import Alert (IA) dated 10/4/2021 updates the reason for alert section, guidance section, product description, and charge section. Changes to the import alert are bracketed by asterisks (***).| www.accessdata.fda.gov
Links on this page:| www.accessdata.fda.gov
Health professionals, consumers and patients can voluntarily report observed or suspected adverse events for human medical products to FDA. Voluntary reporting can help FDA identify unknown risk for approved medical products. Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (Health Professional) or 3500B (Consumer/Patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.| www.accessdata.fda.gov
U.S. Food & Drug Administration| www.accessdata.fda.gov
The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last ten years. Reports older than ten years are provided on the FDA's MDR Data Files webpage. | www.accessdata.fda.gov
U.S. Food & Drug Administration| www.accessdata.fda.gov
Health professionals, consumers and patients can voluntarily report observed or suspected adverse events for human medical products to FDA. Voluntary reporting can help FDA identify unknown risk for approved medical products. Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (Health Professional) or 3500B (Consumer/Patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.| www.accessdata.fda.gov