FDA Registration

December 9, 2013

How to register facilities and products, and how to update registrations

Food Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA. Read more about fees >
November 9, 2013

Registration of Food Facilities

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring that: Food facilities register […]
November 9, 2013

Drug Master File

The information contained in the Drug Master File (DMF) may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application or amendments and supplements to any of these. The US DMF contains factual and complete information on a drug product chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product.
February 9, 2013

Combinations of Medical Devices with CE Marking

According to CE Marking MDD article 9.1 and the “Essential Requirements” in annex 1 of the Directive 93/42/EEC, when a medical device is intended for use in combination with another medical device or other equipment, the combination, including the connection system, must be safe, and must not impair the specified performance of the individual devices. To ensure safety when putting into service and during use, article 13.6.c and annex 1 of CE Marking Directive 93/42/EEC […]