Life Therapeutics Private Limited

Medical Device Establishment Registration

Any foreign medical device establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a United States (U.S.) FDA agent for that establishment. Information about a foreign establishment's US FDA agent is submitted electronically using the FURLS system and is part of the establishment registration process. Each foreign establishment may designate only one FDA agent. The foreign establishment may also designate its US FDA agent as its official correspondent. The US FDA agent has no responsibility to report adverse events under the Medical Device Reporting regulation.

The responsibilities of the US FDA agent are limited and include:

Establishment Registration and Listing Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA.

As your U.S. FDA Agent, Life Therapeutics will assist you in:

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. Drug products that are not properly listed as required are misbranded and may be subject to regulatory action.

Foreign establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the United States must register with the FDA and identify a U.S. agent. All drugs imported into the United States must be listed by the foreign firm or its designated U.S. agent.

Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label distributors). Changes in the Act, resulting from the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA), require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted.

As your US FDA Agent, Life Therapeutics will assist you in:

A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandular substances, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, soft gels, gel caps, liquids, or powders.

Under Dietary Supplement Health and Education Act, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate scientific evidence to show that claims are not false or misleading. Also, manufacturers need to register themselves pursuant to the Bioterrorism Act with FDA before producing or selling dietary supplements.

Life Therapeutics can help you to:

As your US FDA Agent, Life Therapeutics will assist you in:

United States FD&C Act defined a food-contact substance as "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food."

The U.S. Food and Drug Administration (FDA) established the Division of Food Contact Notification and Review within the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition's (CFSAN), to ensure components of food contact articles, including food packaging and processing equipment, are safe for their intended use. These articles are composed of food contact materials that contain or are made of food contact substances (FCSs). FCSs typically include coatings, plastics, paper, adhesives, colorants, antimicrobials, and antioxidants. FCSs are evaluated primarily through the food contact notification (FCN) program; Food contact notifications are required only for new uses of FCSs that are food additives. A notification is not required for a food contact substance that is Generally Recognized as Safe or prior sanctioned for its intended use in contact with food.

It is the responsibility of the manufacturer of an FCS to ensure that food contact materials comply with the specifications and limitations in all applicable authorizations. Life Therapeutics could help chemical, and food contact substance manufacturers to register their product with U.S. FDA.

Life Therapeutics can help you to:

Foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. are required to have an FDA agent. The US FDA agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. FDA agent cannot use a post office box as an address. U.S. FDA agent must be available to answer the phone or have an employee available to answer the phone during normal business hours. The FDA agent acts as a communications link between US FDA and the food facility for both routine and emergency communications, unless the facility designates a different emergency contact.

As your US FDA Agent, Life Therapeutics regulatory consultant will assist you in:

Voluntary Cosmetic Registration Program (VCRP)

The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Included in this definition are products such as skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colors, toothpastes, deodorants, and any material intended for use as a component of a cosmetic product. Cosmetics are not subject to FDA premarket approval or mandatory establishment registration or ingredient reporting. It is the firm's responsibility to assure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the law.

US FDA agent is not mandatory for Cosmetic establishments, US FDA agents cannot open VCRP accounts on behalf of the manufacturer, but US FDA agents can assist the manufacturer in filing product ingredients with US FDA.

As your US FDA Agent, Life Therapeutics will assist you in:

Cosmetic Facility establishment registration with the US FDA

Cosmetic Product Ingredient Statements (CPIS) Filing with the US FDA