Manufacturers and distributors of FDA regulated products always ask this question. FDA approval is not required for all regulated products, FDA approval is required for High-risk products like class III medical device and Drugs (non-OTC Monograph). FDA approval pathway for Drugs is NDA (New Drug Application) and ANDA (Abbreviated New Drug Application).
FDA approval is not required for food or dietary supplement products. Food and supplement product manufacturers must register their facility with FDA, if a manufacturer has more than one facility, they need to register each facility with FDA and FDA will assign a unique 11 digit FDA registration number for each facility location.
Cosmetic products do not require FDA approval or FDA registration, the label and ingredients must comply with FDA cosmetic regulations.
FDA requirement for a medical device depends on its classification, most class III and some Class II medical devices require FDA approval called PMA (Pre-Market Approval). Class II and some Class I device (like examination and Surgical Gloves) require FDA clearance, often referred to as FDA 510K Clearance. If your device is 510k exempted – most class I device comes under this category – you don’t need FDA Clearance or approval. All medical device manufacturers and processors including importer must have FDA establishment registration. LMG can assist you to find out whether your device requires FDA approval, FDA clearance or FDA registration, please contact us at info@fdahelp.us
