According to WHO, Medical device is defined as any article, instrument, apparatus or machine that is used in prevention, diagnosis or treatment for detecting, measuring, correcting or modifying the structure or function of body. Medical devices are regulated under Schedule Y of the Drugs and Cosmetics Rules,1945.
Classification of medical devices
Therapeutic Goods Administration (TGA) - Australia classified medical devices into 5 types based on risk level.
Classification Risk Level Examples:
Stages of medical device clinical trials:
CREATION OF PROTOTYPE
It involves four stages: alpha, beta and pilot prototype and a mature product.
Alpha Prototype: Primary step of organizing the device. It is crucial in indulging device limitation and refining the design.
Beta Prototype: Combines the design refinements established in alpha prototype and execute them.
Pilot Prototype: Merging of validation testing and Refinements from beta development verification into design and production method
Mature Product: Refinements from user feedback and production checking are combined
At this stage, investigators assess the prototypes in organized laboratory settings to diminish the risk of harm in humans. It includes:
• Computer stimulations: Computer stimulations affords precise estimates of the device effects in humans
• Bench testing: Laboratory testing to evaluate the performance and safety of medical device
• Technical testing: Engineering and quality testing to measure the reliability and accurateness
• Animal studies: Used to evaluate its toxicology, safety and biocompatibility
Device manufacturers need to apply for Individual Device Exemption (IDE) from FDA Before conducting clinical trial. When US FDA approves IDE, it permits the company to undergo either feasibility study or pivotal study.
Feasibility study: It permits for testing of methods involved and potential trials for example enrollment, approval of use, and further logistics for application
Pivotal study: These are intended to measure the safety and effectiveness of a device for a indicated procedure.
Author: B.RAJESHWARI [PHARM D, CSRPL_INT_ONL_WKD_156/0721] and HEMA DURGASI [PHARM D, CSRPL_INT_ONL_WKD_208/0621]