Medical Devices
According to FD&C act Title 21 CFR part 807, all domestic and foreign medical device establishments that are involved in the production and distribution of medical devices intended to be used in the United States are required to renew their registration annually between October 1st and December 31st every year. Federal government has authorized FDA to collect an annual establishment fee for medical device establishments. List of establishment that need to renew and pay the fees can be found at https://www.fdahelp.us/Pdf/Drug.pdf . The establishment registration fee is not eligible for a reduced small business fee.
All foreign manufacturers must identify at least one importer in their registration before they send the shipment to the United States. In turn, US importers also need to identify the foreign manufacturer at the time of renewal of registration. FDA will verify the manufacturer registration status at the port of entry by comparing the submitted information with CDRH’s establishment registration and listing database. If the information does not match, FDA will ask for more information and also may detain the product at the port if the firm lacks required registration and listing.
Drugs
As per FD&C act Title 21 CFR part 207, all domestic and foreign drug establishments registered with US FDA must renew their registration every year between October 1st and December 31st. The renewal of registration must be submitted to FDA in SPL format via FDA’s Electronic Submission Gateway (ESG) with the same original set id used in original registration. Drug establishments need to update the registration at the time of renewal if there is any change is company information.
All foreign drug manufacturers must update their registration with US importer information at the time of renewal of registration. FDA will verify the registration status of manufacturer at the port of entry by comparing the submitted documents with CDER Drug Establishments Current Registration Site. FDA may consider the drug products misbranded and detain it at the port, if the firm did not renew the registration.
Drug Listing Renewal
As a new regulation started in FY 2016, FDA will deactivate drug listing records in its database that are not properly listed in accordance with FDA requirements as these drug listings are not certified as being active and up to date or the manufacturing establishment is not registered with FDA. FDA wants the registrants to notify if the drugs are not in commercial distribution and ask them to put an end marketing date in the listings. Also, FDA requires firms to submit drug listings updates if there are any material changes to information previously submitted which includes change in manufacturing establishment(s). Drugs with inactivated listing records cannot be legally marketed or imported in the US. The Blanket listing no change certification must be submitted to FDA between October 1st and December 31st every year.
Liberty Management Group Ltd, a leading FDA consulting group provides assistance with medical device establishment registration renewal, drug establishment registration renewal, drug listing renewal and US agent service to foreign countries.
Sudha S
Regulatory Consultant
Mail: Office@libertymanagment.us
What will be the validity of my medical establishment registration if i pay the fee now?
The registration will be valid till December 31st 2020.
I registered my establishment in August this year, do i need to pay again in October? is there a reduced fee?
Yes, you need to renew the registration between Oct 1st and Dec 31st and pay the fees to FDA to keep the registration active for FY 2020.