Month: January 2024

CERTIFICATE TO FOREIGN GOVERNMENT (CFG) – NE (Certificates to Foreign Government for Device Not Exported from the United States.)

Certificates to Foreign Government for Device Not Exported from the United States (CFG-NE) is document issued by FDA issued for legally marketed devices in the U.S that are manufactured by the companies located outside of the United States and are in compliance with the regulations of FD&C act.

Certificates to Foreign Government for Device Not Exported from the United States (CFG – NE) is a self-certification process. By completing the required form, a firm confirms that it is registered with FDA and listed their device with FDA, that each product is legally marketed in the U.S. and is not the subject of an open recall, that all facilities involved in the manufacturing process are complying with the FDA’s regulations, and that each product is not being exported from the U.S.

Requirements to get the Certificates to Foreign Government for Device Not Exported from the United States (CFG – NE)

  1. The manufacturing facility must have a valid medical device establishment registration and must be located outside of the United States.
  2. All devices must be listed with the FDA.
  3. The devices must have cleared Premarket notification (510K) or Premarket Approval (PMA) unless it is exempted by the regulation.
  4. The device should meet all the medical device labelling requirements as of 21 CFR 801 and 809.
  5. The device should be manufactured in accordance with 21CFR 820 also known as Good Manufacturing practice unless it is exempted by the regulation.
  6. Each device(s) identified is not the subject of an import alert, recall, seizure, injunction, or the subject of any other FDA enforcement action.
  7. Manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process, if applicable, have been identified

Certificate to Foreign government can be requested through CECATS system. It is a voluntary electronic system that allows the manufacturers to request export documents online. CECATS can be accessed by logging into the FDA Furls account.

The fees for export certificate from CDRH are $175 for the first certificate and $85 each for additional certificate upon the request from the customer.

Liberty Management Group, a leading FDA consulting firm provides assistance with FDA Medical device registration, device listing and certificate to foreign government application.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

REGISTRATION DE-ACTIVATION

The consequences of not renewing US FDA registration can be significant, depending on the type of facility that operates and the products they manufacture.

Food facilities:

Expired registration: If your registration expires, the FDA will consider it a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Seizure of products: The FDA may seize the products if they believe that the products are manufactured in an unregistered facility or pose a public health risk.

Injunctions: The FDA may seek a court order to prevent from continuing to operate your facility until you come into compliance.

Loss of business: Potential customers and suppliers may be hesitant to do business with a facility that is not in good standing with the FDA.

Medical device establishments:

Expired registration: Like food facilities, an expired registration for a medical device establishment is a violation of the FD&C Act and can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Refusal to approve marketing applications: The FDA may refuse to approve marketing applications for medical devices manufactured in unregistered establishments.

Import restrictions: The FDA may restrict the import of medical devices manufactured in unregistered establishments.

Drugs

Expired registration: Like other registration, an expired registration for drug establishments is also violation of FDA&C Act and can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Refusal to approve marketing applications: The FDA may refuse to approve marketing applications for drugs manufactured in unregistered establishments. They will consider the drug as misbranded and de-activate all the drugs listed FDA.

Import restrictions: The FDA may restrict the import of drugs manufactured in unregistered establishments. Also, they may seize the products if they believe they are manufactured in an unregistered facility or pose a public health risk.

Liberty Management Group, as a renowned FDA consulting firm can help the companies in renewing the food establishment, drug establishment and medical device establishments in a timely manner.

Sudha

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us