REGULATIONS OF MEDICAL DEVICE IN USA

Regulations of medical device plays a very significant role in designing, development and commercializing new medical device and their technologies. Understanding complete regulatory requirements for a medical device will show us essential successful results in innovation. In this article we review about the medical device regulations, classifications and regulatory requirements in United States market. Risk-based classification of medical device is essential for the determination of the medical device regulatory pathway which was implemented by United States Food and Drug Administration (USFDA). At the early stages of development of medical devices we should be cautious about the analysis and consideration significant in the different pathways. Another important aspect of medical device regulation is to outline the specific requirements for testing, production, development and postmarketing surveillance specified by FDA’s QSR (Quality System Regulation). To ensure that the marketed device is safe and effective FDA present its relationship and elements to control the design and operating procedures involved in the manufacturing process. Recent implementations by the USFDA on combination products (combining biologics with devices or drugs with devices) allows for adequate regulations for review purpose. Keywords: PMA, FDA, CDHR, 510(K) process, FD&C,IMDRF, GHTF, IDE, QSR, QM