Medical Devices by Online Compliance Panel

Medical devices are products/devices used by a medical practitioner for diagnosis, surgery or any other type of therapy to cure patients (human or animal). According to Food and Drug Administration (FDA), Medical devices are classified within approximately 1,700 different types and can be broadly summarized within a total of 16 specialties which are described as panels. In order to assure the safety and efficiency of medical devices FDA has assigned three categories. These three classifications are defined by control limits of medical devices, which are, Class I General Controls, Class II General Controls and Special Controls and Class III General Controls and Premarket Approval.  These classifications are based on the intended use of medical devices as well as on their usage indications.

Medical industry today is expanding at a rapid pace and producing enormous opportunities and businesses throughout globe. New technologies and new benchmarks are set almost every day. Manufacturers are adopting sophisticated technologies and using best level of engineering for designing and mass production of these medical devices. Be it a temperature monitoring thermometer or robotics used for complicated heart surgeries. Best strategies and marketing practices are used in positioning these highly evolved medical devices. Innovative technologies and engineering are being used for mass production of such medical devices. Thus have transformed medical field as one of the most demanding industry in the market. 

Due to these increased demands and complexity involved in medical devices it has become essential to maintain a classified system which can ensure regulatory practice in this field. Thus the importance of regulatory practices is essential in order to maintain quality standards in medical devices. FDA has set up a separate department under the name Center for Devices and Radiological Health (CDRH) whose responsibility is to not only to monitor the firms who are involved in manufacturing and packaging the medical devices but also monitors radiation emitting medical devices like x-rays, ultrasound, MRIs, etc.

Medical devices regulatory requirements are broadly followed for Establishment registration, Medical Device Listing, Premarket Notification or Approval, Investigational Device Exemption for clinical studies, Quality System regulation, Labeling requirements and Medical Device Reporting.

These FDA medical device compliance and regulatory practices are only to promote and protect the public health. These practices are enforces through different acts regulator by FDA just to ensure the safety and effectiveness of these devices. Thus these compliance are must and has to be followed by each manufacturer or produces to attain a level or quality standards and maintain their FDA compliance stature.