clinical evaluation plan

1. Follow Us: ENQUIRY@I3CGLOBAL.COM       SEARCH US FDA HOME US FDA CERTIFICATE  US FDA Certificate The US FDA Certi?cate generally means that companies registered with the US Food and Drug Administration are often asked by their customers and suppliers to verify their FDA registration number and validity date, especially in the case of food manufacturers and exporters.   Manufacturers, Exporters, and Traders across the globe are curious to have the word “FDA Certi?ed” in the name of the company. But this is not possible! The US FDA will not issue any kind of certi?cate to any organization other than domestic manufacturing companies. IMPORTANT TOPICS  COSMETIC REGISTRATION DRUG REGISTRATION FOOD REGISTRATION FDA LABEL  DRUG REGISTRATION FORM REVIEW Are you looking for FDA certi?cation for your medical devices, food, drugs, or cosmetics? Our expert team is here to assist you through the registration and listing process, ensuring your products meet all FDA requirements.  FOOD REGISTRATIONFORM Quick Contact  DEVICE REGISTRATION FORM NAME * COSMETIC REGISTRATION FORM  PHONE * US FDA Agent and FDA Certificate EMAIL * I'AM LOOKING FOR * Domestic ?rms exporting products from the United States are often asked by their foreign customers or foreign governments to supply a “US FDA Certi?cate” for products regulated by the food and Drug Administration. An FDA Certi?cate is a document prepared by the U.S. Food and Drug Administration, containing information about a product’s regulatory or marketing status.   We are US FDA Agents and regulatory consultants having of?ces in the USA, UK, Germany, and India. We provide a certi?cate that acts as a third-party veri?cation of your registration status. Third-party certi?cates will not possess legal validity, and the US FDA does not acknowledge these issued certi?cates of registration. To obtain a certi?cate, please write to us or ?ll out the quick contact form on the left side. Select YOUR ASK * What is the pr MESSAGE Submit FDA Food Facility Registration FDA Food Label Review US FDA Certificate Validity US FDA Certi?cate issued by US Agent is valid for 1 year from the date of issue. The validity of the certi?cate can be increased based on request and payment. FDA food facility registration is con?dential. FDA never discloses registrant information

2. to the public. Due to this reason, your potential buyer from the USA can ask for additional information such as login details or FDA Agent issued US FDA Certi?cate. Our US FDA Certi?cation fees start at 350 USD depending upon the product and type. We will organize the certi?cate in six hours’ time on working days.  CONTACT US FDA Certificate Vs FDA Approval FDA certi?cation generally refers to formal documentation issued by the FDA or any third party that certi?es compliance with speci?c standards or regulations. whereas FDA approval is a formal document after a rigorous process to evaluate the safety, ef?cacy, and quality of drugs, biologics, and high-risk medical devices.   Across the globe, many manufacturers use the word “FDA Approved” on their primary labels, secondary packages, and websites. This is NOT correct! It is added only for commercial promotions. The U.S. Food and Drug Administration never accepts the statement.   FDA doesn’t approve manufacturers of any kind of activity. FDA approves new medical devices and certain high-risk medical devices. FDA doesn’t approve Food, Cosmetics, OTC Drugs, and Compound drugs. FDA approves new drugs and biologicals before companies can market those items. Frequently Asked Questions What is FDA Color Certificate?  All colour additives, except coal tar hair dyes, need prior FDA Approval before being used in food, drugs, or cosmetics. The FDA Color Certi?cate is for the batches of colour manufactured to use in/on humans and animals. It is issued after thorough analysis at designated facilities by the FDA. FDA issues colour certi?cates based on the test result. Can I advertise my facility is FDA Certified?  FDA will NOT issue any certi?cate, so you cannot say your facility is FDA Certi?ed. How much does it cost to get FDA approval?  The cost of FDA Approval depending on the products. Contact us for more details. What is the validity of US FDA Certificate?  The FDA certi?cate issued by a US FDA Agent is valid for 1 year from the date of the initial issue. To obtain a US FDA Certificate?  The US FDA will not issue any certi?cate. We FDA Agents issue certi?cates soon after the facility or establishment registration with the FDA using our US Agent Service. What is an FDA Certificate?  An FDA Certi?cate is issued to domestic manufacturers by the Food and Drug Administration for the smooth acceptance of US products in other countries. Application Forms

3. Quote Request Forms Recent Post Templates for Sale FDA Food Registration  FDA Drug Registration  Document Control  FDA Medical Device  May 17, 2024  FDA 510(K) Risk Analysis   Registration Validation of Software Used  MDR CE Marking MDR Technical File   Cosmetic Product Listing  in QMS IVDR CE Marking MDR QMS   Cosmetic Facility  May 10, 2024  Registration Clinical Evaluation Report Clinical Evaluation   IVDR Transition Timeline  European Representative Periodic Safety Update   December 21, 2023  Reports Biocompatablity Testing  510k Certi?cate  Post-Market Clinical Follow-  ISO 13485  March 18, 2023  Up 21 CFR 820  Biological Evaluation  UK Responsible Person  Post Market Surveillance  GMP Certi?cation  ISO 13485:2016  US FDA DMF       I3CGLOBAL © 2024 All Rights Reserved