The FDA Group’s CEO, Nick Capman, sits down with Regulatory Consultant Trey Thorsen, MS, RAC, to answer some of the most frequently asked questions about navigating the 510(k) premarket notification process.
Trey brings experience in Class I, II, and III devices, such as active implantables with MRI functionality, external therapeutic devices indicated for pain, devices that have software functionality, transvaginal catheter systems that evaluate fallopian tube patency, sterile and non-sterile wound care devices, compression devices, surgical booms, surgical lights and devices indicated for incontinence. He also has experience with 513(g)s, Pre-Subs and CFGs, UDI/GUDID implementation, as well as EU MDR technical file development and remediation.
Some of the questions Trey tackles include:

"I would like to distribute a manufacturer's product under my own company name. Do I need to submit a 510(k)?"
"Can foreign companies submit a 510(k)?
"Besides the fees for paying a consultant to help me put this together, are there any other fees I should be aware of?
"How much does a U.S. Agent typically cost?"
"Do I need to register my facility before I submit a 510(k)?"
"Do I need to provide documentation that my facility complies with the quality system in my 510(k)?"
"Do I need to have my facility inspected to the Quality System Regulations before I submit a 510(k)?"

Need expert 510(k) assistance? At The FDA Group, we help you move through the 510(k) submission process quickly and efficiently. Our regulatory affairs consultants, many of whom are former FDA personnel, have years of experience working with and within the agency. Learn more about our 510(k) consulting services and get in touch with us to access the industry's best regulatory affairs consultants.
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