FDA 510K CONSULTANTS, LLC
Clients hire us mainly to clear medical devices through FDA's 510(k) program. This often leads to help with related issues, such as registering with FDA and importing devices into the country. We generally provide such extras at no charge.
Establishment registration and device listing
Medical device manufacturers and importers must register with FDA and pay an annual licensing fee. In addition, they must list all medical devices to be marketed in the United States. We handle this service at no charge after clearing your 510(k).
IMPORT AND EXPORT ACTIVITIES
Getting devices into the country... or out
The U.S. allows you to import medical devices duty free. That's the good news. But if shipments are not labeled properly, customs agents impound the goods and cause insufferable delays. In addition, FDA recently implemented a new system for radiation-generating devices, which must carry unique "accession" numbers. We help clients overcome these import hurdles. We further help you obtain Certificates to Foreign Governments (CFGs) when exporting to markets that rely on FDA "approval" for regulatory responsibility.
UNIVERSAL DEVICE IDENTIFIER
Compliance with new UDI regulations
FDA's new Universal Device Identifier system began phasing in during 2014. Class 2 devices, which generally include those under the 510(k) umbrella, face a significant labeling and reporting deadline in September 2016. FDA 510k Consultants offers free guidance on this significant new regulatory burden on medical device manufacturers and importers.
OTHER MEDICAL DEVICE REGULATIONS
Small business designation; US agent
The first step with a new engagement is to file for Small Business Designation (SBD), which takes about 45 days. This saves the client $2,345 (50% of FDA's review fee).
Foreign companies must name a domestic person or corporation its US Agent for notices from the agency. We often serve this function for foreign clients.