Regulatory Procedures to be followed by Medical Devices Testing for Approvals in the U.S.
Medical device tests are performed in two phases, i.e., inhouse and outsourced. In-house testing is wherein all tests are carried out by the manufacturer at their facility. Outsourced testing is the one where the contract for testing is given to a third party, and they further update the manufacturer with the feedback. These are basically tests which medical device manufacturers undergo to fulfill certain unique testing requirements enforced by various regulatory bodies across the globe in order to commercialize their medical devices.
In the recent past, the global medical devices testing services market has undergone enormous growth. There has been an extensive technological advancement in specifications of medical devices for various procedures. A rise in the procedural volume of different types of surgeries and a rise in the prevalence of chronic diseases has led to preferences for minimally invasive surgeries.
As per the market intelligence published by BIS Research, the global medical devices testing services market, by test revenue, generated $1,328.2 million in 2018 and is expected to grow at a CAGR of 10.81% during the forecast period from 2019 to 2029. The market growth can be accredited to the increasing innovations and technological advancements in the medical device industry.
Medical devices in the U.S. are defined under three categories, Class I, Class II, and Class III by the U.S. FDA. Class I devices require the least amount of regulatory control are exempt from the premarket notification, and these devices include tongue depressors, hand-held surgical instruments, and arm slings.
Class II medical devices require pre-market notification by submission, should comply with both General Controls and Special Controls and include X-Ray systems, surgical drapes, pumps, and physiologic monitors, among other things.
Lastly, class III medical devices are subjected to the most stringent regulatory controls. Pre-Market Approval (PMA) submission to FDA is required to allow the marketing of these devices, and they include devices related to breast implants, implantable pacemakers, and surgical robots.
The market study also highlights the strategies adopted by the companies in the past four years from January 2016 to February 2020 in the global medical devices testing services market. The global medical devices testing services market is dominated by juggernauts, including Eurofins Scientific Group, Charles River Laboratories International, Inc., Bureau Veritas S.A., and other medium and small-medium enterprises. Among the different key developments, mergers and acquisitions and service expansions constitute the largest share.
For the purpose of the study, the global medical devices testing services market is segmented on the basis of test type and region. The test types included are device sterility assurance & microbiology testing, device biocompatibility testing, device stability testing, and device stability testing, among others.