US FDA explains e-registration process for device firms
This article was originally published in SRA
The US Food and Drug Administration has issued a guidance document explaining how medical device companies can register their establishments and list their products electronically with the agency1,2.
The requirement for electronic registration was made mandatory under the FDA Amendments Act of 2007. The statute was signed into law on 27 September 2007, and became effective on that date for device establishments registering with the FDA for the first time (ie initial registration), and on 1 October 2007 for device establishments completing their annual registration.
Companies unable to submit the required information electronically must seek a waiver from the FDA, by submitting a written request offering a complete explanation.
The guidance document, which applies with immediate effect, also describes the information that owners/operators of device establishments are required to submit as part of the registration process. Additionally, it identifies the rates for user fees for each fiscal year through FY 2012 that certain types of device establishments are required to pay in connection with their initial or annual registration.
For FY 2010, medtech companies have until 31 December to complete the registration process, which got under way on 1 October.
The electronic registration programme is designed to allow the FDA to more effectively gather information on who is manufacturing medical devices and where. Having this information, the FDA said, increases the nation’s ability to prepare for, and respond effectively to, bioterrorism threats and other public health emergencies.
No affiliate agencies
The FDA said it is aware that various firms may be offering their services to assist domestic and foreign medical device manufacturers to register with the FDA3.
The agency clarified that these firms are not affiliated with the FDA in any way. “FDA does not use any outside contractors to notify or bill regulated industry about the need to register,” the agency said, adding that it does not require medtech companies to hire someone to complete the online registration process.
References
1. Federal Register, 8 October 2009, 74(194), 51864-51865, http://edocket.access.gpo.gov/2009/pdf/E9-24349.pdf
2. FDA, Guidance for Industry and FDA Staff: Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007, Issued on 8 October 2009, www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM185877.pdf
3. FDA, Important Reminders about Registration and Listing, Page last updated 17 September 2009, www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm153205.htm