Tag: FDA Medical Device registration renewal

WHO NEEDS TO REGISTER, LIST AND PAY FOR MEDICAL DEVICE REGISTRATION

Companies including foreign and domestic establishments that are engaged in manufacturing and marketing medical devices including export only devices are required to register yearly with US FDA. Registered establishments are required to list the devices along the activities made on the devices too.

  The following are the businesses that are required to register and list the devices.

Manufacture: Establishments that makes by chemical, physical, biological, or other procedures, any article that meets the definition of “device”.

Contract Manufacture: Establishments that manufacture the device as per other establishment specifications.

Specification Developer: Companies that develop specifications for a device that is distributed under the establishment’s own name but performs no manufacturing.

Contract Sterilizer: Provides a sterilization service for another establishment’s devices.

Repackage- Establishments that package the finished devices into different containers excluding shipping containers.

Relabel- Establishments that change the content of the labeling that they have received from the original manufacturer for distribution under the establishment’s own name.

Foreign Export: Establishments that export the devices from a foreign country including the devices manufactured in the United States.

Re-manufacture: A person or establishment who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.

Export only device: Companies who manufactures the devices that are sold only in foreign countries and manufactured in the United States.

Complaint file establishment: Establishments that manage only complaints.

Initial Importer: Any company who furthers the marketing of a device from a foreign manufacturer to the person who makes final sale of the device to the consumer but does not perform any other action on the device.

Establishments that are registered with US FDA must renew their registration every year between October 1st and December 31st every year by paying FDA’s MDUFA fees.

Liberty Management Group, as a leading FDA consultant, helps with MDUFA payment, FURLS account creation, medical device establishment registration, device listings and renewals.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

FDA REGISTRATION RENEWAL TIMELINE

FDA registration renewal process is applicable to various FDA regulated products, including food facilities, medical devices, drugs, and more. However, specific renewal requirements and processes are needed based on the type of product or establishment.

Below are the timeline for FDA registration renewals.

Food Facilities: Food facilities must renew their FDA registrations every two years. The renewal period usually opens in October of even-numbered years. Registered food facilities need to submit a renewal registration between October 1st and December 31st of each even-numbered year.

Medical Devices: Owners or operators of establishments that manufacture, repackage, relabel, or remanufacture medical devices for commercial distribution must renew their registration annually with the FDA. This registration must be renewed between October 1st and December 31st each year and pay FDA fee.

Drug Establishments: Establishments involved in the manufacture, repackaging, relabeling, or salvaging of drugs must register with the FDA. Drug establishment registrations must be renewed annually between October 1st and December 31st every year.

Drug listings: All drug establishments must renew or certify their drugs listed in the previous fiscal years, between October 1st and December 31st every year. During this renewal period companies must inform FDA about any update or changes in their drug listings. If they no longer market the drugs, it must be de-listed with marketing end date.

Liberty Management Group , as a leading FDA consultant will provide assistance  with food registration biennial registration renewal, drug establishment registration renewal, medical device registration renewal and drug listing renewal.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us