A medical device can be “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory”. Medical devices can be simple tongue depressor and bedpan to complex machines such as laser surgical devices and programmable pacemakers with micro-chip technology. These can also include general purpose lab equipments, test kits and reagents that encompass monoclonal antibody technology. Electronic radiation emitting products such as medical lasers, x-ray machines and diagnostic ultrasound products also come under this category. These medical devices are subjected to premarketing and post-marketing regulatory controls.
Medical Devices and FDA
Medical devices as recognized by the FDA are intended for use in disease diagnosis or to cure, treat, mitigate or prevent diseases in man or animals. There is a clear distinction between a medical device and a drug. Medical device manufacturers are increasingly becoming innovative and introducing powerful products in the market. When production and marketing are so rampant, there needs to be a full-proof system to ensure regulatory obligations.
CDRH or Center for Devices and Radiological Health of the FDA regulates firms that manufacture, repackage, re-label and import medical devices that are sold in the country. These regulatory stipulations include FDA GXPs and reporting mandates, cross-industry compliance requirements as per laws such as Sarbanes Oxley Act (SOX) and international device safety standards and marketing laws. Regulatory requirements are defined as per the classification of medical device: Class I, II and III.
Medical device manufacturers in the United States must adhere to fundamental regulatory requirements such as establishment registration, medical device listing, premarket notification 510(k) or premarket approval, investigational device exemption, quality system regulation, labeling requirements and medical device reporting.