Welcome to LMG. This is the place for asking questions regarding US FDA registration (drug and medical devices ) and to find previous answers to your questions
by Liberty Management Group Ltd.
Welcome to LMG. This is the place for asking questions regarding US FDA registration (drug and medical devices ) and to find previous answers to your questions
what is US FDA Registration ?
FDA Registration section for each product is different, if you are looking for a food facility registration, as per 21 cfr part 1 subpart H, the owner, operator, or agent in charge of a domestic or foreign facility, who is engaged in the process of manufacturing/processing, packing, or holding of food for consumption in the United States must register with FDA, this process of registering the facility is known as US FDA registration. Domestic facilities must register with FDA whether or not the food from the facility enters interstate commerce
can i get FDA Certificate immediately after registration ? is this certificate issued by US FDA ? how much is the fees for FDA certificate ?
FDA will not issue any certificate after registration, LMG will issue FDA Registration certificate after successfully completing the registration as a proof of registration. LMG issue free fda registration certificates to our clients.
Can i use Benzethonium chloride as an active in antiseptic hand sanitizer ?
As per FDA final rule, Benzethonium chloride is in the list of ineligible active ingredients, you can not market a hand sanitizer with this active ingredient. if you already have a product listed with FDA, you need to de-list it or change the formulation with FDA approved active ingredient.
what is an FDA OTC Monogrpah ?
FDA OTC Monograph is a database of active ingredients and its intended purpose, it also define the safety, effectiveness, and labeling of OTC active ingredients. If a drug is in OTC final monograph, companies can manufacture and market that OTC Drugs without FDA pre-approval.
when i want to renew my drug establishment registration ?
All Drug Establishments must renew their FDA registration every year between October 1st and December 31st. if not renewed FDA may remove the establishments from its registration database, and may consider the products of these establishments as misbranded.
hi,
we are the manufacturer of “Chitosan wound dressing” based in South Korea, do we need US FDA Registration to market this product in the USA ? if yes what are the FDA requirements for this product ?
YES, Chitosan wound dressing require US FDA Registration, Chitosan wound dressing is regulated as a medical device by US FDA. The FDA product code is “FRO“. Chitosan wound dressing require a FDA 510K Clearance to market in the USA. The 510 k notification need a comparison with predicate device and need to submit all required test requirements including bio-compatibility testing. a typical Chitosan wound dressing 510 k notification require the below testings.
Hi,
we are the leading latex examination glove manufacturer from Malaysia, we are on the process of exporting to US and Canada. Is there any specific labeling
requirements for latex glove for USA and Canada ? thanks in advance.
Yes, there is specific FDA labeling requirements for latex examination and surgical gloves. Which includes Caution statement for Natural Rubber Latex and Protein contents.
how long it takes to complete drug establishment registration with US FDA ?
We will complete FDA registration within one week. if you need a labeler code also, it may take upto 2 weeks