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General FAQs

Why has Congress authorized user fees for medical devices?
Why has Congress authorized third-party device establishment inspections?
Why did the FDA ask the Transmissible Spongiform Encephalopathy Advisory Committee (TSEAC)and the Vaccines and Related Biological Products Advisory Committee(VRBPAC) to meet on July 27th, 2000?
Who can be accredited to conduct third-party inspections?
Which establishments are eligible for inspection by a third-party?
Where can I search for a clinical trial?
Where can I find a list of current licensed products and establishments regulated by CBER?
When will FDA require premarket reports for class III reprocessed single-use devices?
When does MDUFMA expire?
When did FDA begin MDUFA user fees?
What types of medical countermeasures are currently available in the event of a terrorist attack?
What were the FY 2003 MUDFMA user fees?
What regulations or guidance documents exist that would help with investigation and development of safe and effective new products that might be used in countering bioterrorism?
What is the Medical Device User Fee and Modernization Act of 2002?
What can happen if an establishment does not pay a MDUFMA fee that is due?
What are my responsibilities as an importer of biological specimens that are intended for testing in a clinical laboratory or for basic scientific research only?
Under what circumstances will FDA refund part of a MDUFMA fee that has been paid for a premarket application, premarket report, or supplement?
If a reprocessed single-use device was 510(k) exempt before the new law, is it still exempt?
I am trying to import biological specimens (e.g. blood, tissue, DNA) for testing in a clinical laboratory or for basic scientific research. Does the FDA regulate biological specimens intended only for testing in a clinical laboratory or use for basic scientific research?
How will FDA show that medical device review performance is improving under MDUFMA?
How much does an inspection cost under MDUFMA, and who pays for it?
How does MDUFMA strengthen device postmarket surveillance?
How do I file a request under the Freedom of Information Act (FOIA)?
How do I file a request under the Freedom of Information Act (FOIA)?
How can I facilitate the entry of my biological specimens?
How can a small business qualify for reduced MDUFMA fees?
How are reprocessed single-use devices regulated under MDUFMA?
Has the Center for Biologics Evaluation and Research had any involvement in countering bioterrorism?
Has CBER approved any new biologics under the Animal Rule so far?
Does FDA regulate organ donation?
Does CBER publish a list of all current Investigational New Drugs (IND) and Biologics License Applications (BLA)? Does CBER post presentation that are given by CBER staff?
Can an Establishment pay MDUFMA fees elctronically?
Are there fee waivers, exemptions, or reductions to MDUFMA user fees?
Are there effective controls to prevent possible conflicts of interest in the third-party device inspection program?
What is the contact information for CBER's Manufacturers Assistance Branch?
Which tissues are regulated by CBER?
What are Current Good Manufacturing Practice (CGMP) regulations?

Last revised: March 29, 2007