The US Food and Drug Administration (FDA) has announced a list of 1,003 class II device types that it believes are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.
In an attempt to decrease regulatory burdens on the medical device industry and reduce private costs and expenditures required to comply with federal regulation, the FDA is exempting or partially exempting (exempting with limitations) the listed devices from the premarket notification [510(k)] requirements.
Medical device types that are exempt from 510(k) are not exempt from other regulatory controls, except in instances when such exemption is explicitly provided by order or regulation. Every medical device must be manufactured under current good manufacturing practice requirements, be suitable for the intended use, be adequately packaged and properly labeled, and have current establishment registration and device listing with the FDA. Contact us
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