I 3 Consulting

August 9, 2014

FDA Medical Device Registration and Listing

Medical devices are classified into Class I, II, and III. All the devices need to register with USFDA before marketing in USA. Most Class I devices are exempt from Premarket Notification 510(k) AND most Class II devices require Premarket Notification 510(k), before registration and Listing The basic regulatory requirements that manufacturers of medical devices distributed in the U.S.A must follow and comply Read More about further activities and Medical Device Establishment Registration
July 9, 2014

Failed to REGISTER with FDA !!!

Failure to register your facility – No entry of listed food and related products to USA. It will be send back to original destination OR destroyed. Food manufactured, processed, packed, received, or held by a registered facility has failed in random inspection of FDA inspectors , It will be send back and suspend the registration. All about Food FACILITY registration
June 9, 2014


A food facility is required to submit an initial registration to FDA only once. further your facility to renew its registration with FDA every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year. IMPORTANT – No further information to be provided during the FDA Food Facility renewal process. The US FDA Agent will take care of the renewal and intimate you on time. US Agent Service
May 9, 2014

FDA Registration for what type of foods

Food Included in the Regulation are the following Dietary supplements and dietary ingredients Infant formula Beverages (including alcoholic beverages and bottled water) Fruits and vegetables Fish and seafood Dairy products and shell eggs Raw agricultural commodities for use as food or components of food Canned and frozen foods Bakery goods, snack food, and candy (including chewing gum) Live food animals Food for animals (e.g., pet food, pet treats and chews, animal feed) To know more […]