Title 21 of the Code of Federal Regulations

Based in Teaneck, New Jersey, John Klein leads Cambridge Therapeutics as chairman. John Klein has strategically guided Cambridge Therapeutics in this role since 2011, relying in part on his knowledge of the Code of Federal Regulations put out by the US Food and Drug Administration (FDA). 

In order to enforce federal requirements governing medical devices and products that emit radiation, the FDA develops and implements regulations for the industry. These regulations are first published online in the Federal Register and ultimately printed in the Code of Federal Regulations (CFR), which is published annually. 

The CFR comprises 50 titles that cover a broad spectrum of regulations. Title 21 (Parts 800-1299), which applies to medical devices and radiation-emitting products, includes specifications for the design, clinical evaluation, manufacturing, packaging, labeling, and after-sale tracking of medical devices. Title 21 also covers relevant standards and required reporting for products that emit radiation.