Month: September 2019

MEDICAL DEVICE AND DRUG RENEWAL REQUIREMENTS

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

www.fdahelp.us

ANIMAL DRUGS

According to FD&C Act, the term “drug” means articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles other than food intended to affect the structure or any function of the body of man or other animals which also includes articles intended for use a  component of a drug.

 As per FD&C Act “new animal drug” is a drug intended for use in animals which is not in GRASE (Generally Recognized as Safe and Effective) , in other words, if a drug is in GRASE list, then it is not a new animal drug under FDA&C Act.

Unapproved Animal Drugs are new animal drugs that cannot be marketed legally.  FDA does not approve or index them.  It is not legal to market unapproved new animal drugs as they didn’t gone through FDA pre-market review and got legal marketing status under FD&C Act.  Unapproved animal drugs may not meet FDA’s standard for safety and effectiveness and also may not be properly manufactured or labeled.

There are three ways to get a Legal Marketing status of an animal drug.

  1. Approval
  2. Conditional Approval
  3. Indexing

Approval: An approved animal drug has to go through NADA (New Animal Drug Application) process or for an ANADA (Abbreviated New Animal Drug Application) process for an approved generic animal drug. FDA approval means the drug is safe and effective when the drug is used as per the label and also it makes sure that the drug’s strength, quality are consistent for each production and the labeling is correct not misleading.

Conditional Approval: Conditional approval is only for drugs for major species with minor uses.  FDA‘s Conditional approval means the drug is safe to use and has reasonable effectiveness when used as per the label instruction. This approval is valid only for one year. Drug companies can ask FDA to renew the approval for up to four more years.  So during that 5 year period, companies can sell the drug legally and can also collect effectiveness data.  After collecting the data, the company can submit the application to FDA for full approval.

Indexing: An indexed animal drug is a drug listed on the FDA’s Index of Legally Marketed Unapproved New Animal drugs for minor species which is unapproved by FDA but has legal marketing status.  Indexing is allowed for drugs used on minor species such as pet birds, hamsters and ornamental fish which are non-food producing.  Indexing is different from regular drug approval process.  A panel of qualified experts outside FDA will review the drug’s safety and effectiveness in the specific minor species. If FDA agrees with the panel, it will add the drug to the Index.

All domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA and also list all of their drugs that are commercially. Also all the establishments that are registered with FDA are required to renew their registration between October 1st and December 31st every year to keep their registration active.

Liberty Management Group Ltd, a leading FDA consulting firm provides assistance with drug establishment registration, drug listing and US agent service to foreign establishments.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us