FDA combination products

The FDA office of combination always adheres to the products that were established on December 24, 2002. It is required by SEC which has been considering by the medical device user free and modernization act of 2002. In fact, the law gives the OCP broad responsibilities which are covering the regulatory life cycle of combination products. This has been evaluated in making a proper decision according to the code of Federal regulations CFR. The combination of products involves a medical device and or a drug acquires biological impacts. It is taking place by combining any two products which have separate categories and sometimes even all three products included.

It has new contrast imaging indication which has been discovered with approved drug and biological products. This should discover with a process to lead with human cells, tissues, and cellular and tissue-based products. It is evaluating under early development considerations for innovative combination products. This is capable of arranging with the right devices and means to carry out approved drugs for overall biological products. Moreover, combination products are developed in accordance with the life cycle of combination products. It is covering based on the regulatory life and carry out by premarket pathways.

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