iMTATs FDA Compliance

The US Food and Drug Administration (FDA) now regulates over 22% of all goods sold at retail in the USA, amounting to over $2.8 Trillion of products sold at retail per year.

This includes:

• Foods, Beverages, and Supplements

• Medical Supplies and Devices

• Pharmaceutical Drugs

• Cosmetics

• Biologics

• Blood and DNA products

• Anything that comes into contact with the human body, such as bandages or suntan lotion.

• Anything used in the manufacture or packaging of any of the above items

As a result, an ever increasing number of manufacturers and distributors are finding themselves coming under the jurisdiction of the FDA, as some or all of the products they sell end-up being used in FDA regulated applications.

The purpose of iMATs is to provide an affordable solution, to enable manufacturers and distributors to comply with the materials tracking and traceability, barcode labeling, and supply chain data exchange requirements of the following acts and regulations:

• The Federal Food, Drug, and Cosmetic Act (FFDCA)
• The Fair Packaging and Labeling Act (FPLA)
• The Food Safety Modernization Act (FSMA)
• The Drug Supply Chain Safety Act (DSCSA)
• The Modernization of Cosmetics Regulation Act (MoCRA)
• Safe Quality Foods Certification (SQF)
• Hazard Analysis and Critical Control Point (HAACP)
• Bioterrorism Act of 2002

iMTATs is CFR 21 Part 11 compliant and can be used for materials tracking and traceability in the manufacture of medical devices and supplies, as well as pharmaceuticals and in laboratories.

Please click here to download a PDF a copy of "iMTATs Compliance with CFR 21 Part 11"

iMTATs is compliant with the Global Standards One (GS1) data collection and supply chain data exchange architecture. Please click here to learn about iMTATs GS1 compliance.