FDA Approval - FDA Registration
"FDA Approved" is a common term used on product labels, especially products marketed on internet sites. Do they are really approved by FDA? FDA approve a product only after review the safety and effectiveness of the product. Most products do not require FDA approval to market in the USA, only FDA registration is required. Also, FDA does not approve manufacturing establishments, FDA may conduct an audit / inspection against GMP compliance, A successful FDA audit / inspection without any non-compliance does not mean FDA approval of the establishment.
FDA Approval for Food
FDA does not approve food or food facility. Food facility must register with FDA and list product categories. FDA will assign 11-digit registration number immediately after successful registration. food label must comply with FDA label requirements, but it is the manufacturer / distributor responsibility to make sure product labels are in full compliance, FDA will not review and approve food labels.
New food additives, new dietary ingredients and some color additives are exemption for the above which require FDA approval to market.
FDA approval for Dietary Supplement
Dietary supplement does not need FDA approval, only new dietary ingredient need FDA approval. Facility registration, GMP, label and ingredient compliance are the requirements.
FDA Approval for Medical Device
Generally, Class I and Class II medical devices do not require FDA approval, Most Class III device require FDA approval to market in the USA. Class II medical device require only a marketing clearance from FDA (510k) which is not an approval. Most class I device have only general controls. All medical device establishments require FDA registration and device listing.
FDA approval for cosmetics
FDA does not approve cosmetics, cosmetic products and establishment even doesn't require a registration or listing to market. Cosmetics must comply with label and ingredient requirements.
FDA approval for Drug
Drug products complying with OTC Monograph does not require FDA approval, other drugs require NDA or ANDA approval. Homeopathic drugs complying with HPUS doesn't need FDA approval. FDA Registration, NDC labeler code, drug listing and label compliance are common requirements for all drugs.
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