United States
The article highlights the critical points of the regulatory approach concerning specific medical devices intended to be marketed and used in the Philippines.
United States
The article provides an overview of the reclassification process commenced by the US medical device regulatory agency.
Also, it outlines the specifics of such a process in the context of high-risk in vitro diagnostic medical devices.
United States
The article describes in detail the approach to be applied with respect to non-clinical bench testing medical devices should undergo in order to collect necessary safety data to support the relevant claims included in the premarket submission.
United States
The article addresses specific aspects to be taken into consideration concerning premarket submissions for orthopedic devices with metallic or calcium phosphate coating, including the ones related to clinical testing, labeling, and modifications.
United States
The article provides additional recommendations related to the description of devices to be included in premarket submissions to ensure the authority has the comprehensive information it needs to complete the review.
United States
The present article outlines the key points related to the existing legal framework and explains the basics of the approach to be followed.
