Services to Ease FDA Regulatory Compliance

How To Register With The FDA

18

Oct

2019

The US FDA requires facilities who are engaged in manufacturing, processing, packaging or storing food pharmaceuticals, and medical devices sold in the United States to register with the FDA. Therefore, pharmaceutical and device manufacturers must list their facility and list the products. Companies must annual renew the registration and listings.  FDA US agent is required for foreign facility registration who can also assist for registration and listing. 

The number of laws and oversight can be very overwhelming if you are new to the US market. It’s much better to adopt from the very start instead of trying to fix mistakes after they’ve happened.

FDA Registration and listing   of Medical Devices:

You must register your organisation with the FDA if you are a supplier or initial distributor/importer of medical devices.

  • To register and list your information, log on to FURLS (FDA Unified Registration and Listing System). A user ID and password for accessing the FURLS must be available to the holder or operator. You will need to create one if you don’t have a FURLS account.

An experienced   FDA consultant can offer you services for medical device registration and listing which can save your time and efforts. 

FDA Drug  Establishment Registration  and NDC drug listing  

FDA Drug establishment registration is mandatory requirement for the companies who manufacturer, process , pack or hold the drug. Such facilities are also required to list the products manufactured in their facility. 

Private label distributors are required list the products which they distribute. 

It is mandatory requirement to renew drug establishment registration annually and update the drug listings between 1st October to 31st December  every year. 

Foreign drug establishments are required to appoint US Agent for FDA registration purpose. US Agent acts as point of contact between foreign company and FDA. US Agent plays important role for your business.

Food/drinks and dietary supplements registration requirements 

Each food company (domestic or external) manufacturing, storing, packaging or keeping food for consumption to humans in the United States shall register its company with the FDA. Facilities are also required to renew the food facility every even year such as 2020, 2022 …

FDA examples from “foods” which may be produced in a registration facility, but are not limited to how to Register Food & Diet supplements

  • Raw food products of the farm,
  • Drinks including alcoholic beverages
  • And water bottles of dairy products
  • And eggs dietary supplements 
  • Animal feeding-stuffs

A separate registration number is provided for each food facility. You might need to register and receive separate registration numbers for food facilities if you own or run many facilities. The second facility may also be required to register if your service is transferred to another installation.

Under the Food Safety and Modernization Act (FSMA), the international establishment will provide the FDA with a designated U.S. agent’s name and contact information. Such agents are the contact link between the food plant and the FDA.

FDA Cosmetic Industry Registration:

Cosmetic Registration, Voluntary Program (VCRP) is voluntary. Companies can market cosmetic products by complying with the below requirements. 

  • Cosmetics should not make disease curing or treatment  claim 
  • The product should comply with FDA labelling requirements for cosmetics  
  • The ingredient does not cause the cosmetic to be adulterated or misbrands
  • The product should be safe to use

FDA US agents will work with you to ensure the safety, proper labelling and enforcement of your goods and ingredients.

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