FDA Clearance & FDA Registration are two separate processes associated with the US FDA.
FDA clearance is a process specific to medical devices. It is applicable to low or moderate risk devices that are categorized by FDA as Class I or Class II. This process is also called 510(k) clearance.
When a manufacturer intends to market a new medical device, they may submit a 510(k) premarket notification to the FDA. This submission demonstrates that the new device is substantially equivalent to an FDA cleared device. In FDA clearance, FDA evaluates whether the new device is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance. If the FDA determines that the device is substantially equivalent, it is cleared for marketing.
FDA registration is required for for various FDA Regulated products, including medical devices, food, drug and cosmetics. FDA registration is for facilities or establishments that are involved in the manufacturing, processing, packing, or holding of FDA regulated products.
Companies engaged in above activities must register their facilities with the FDA. This includes providing information about the types of products manufactured, processes used, and other relevant details. Registration is a requirement for companies involved in the production and distribution of FDA Regulated products. It helps the FDA keep track of facilities and facilitates inspections to ensure compliance with regulatory standards. Upon successful registration, the facility is assigned an FDA registration number.
Liberty Management Group Ltd. can help you with FDA clearance for medical devices and FDA registration for Drugs, Cosmetic, Medical Devices & Food.
Namrata
Regulatory Consultant
support@libertymanagement.us