REPORT ON CERTAIN DEVICES.

SEC. 205. REPORT ON CERTAIN DEVICES. Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall report to the appropriate committees of Congress on the timeliness and effectiveness of device premarket reviews by centers other than the Center for Devices and Radiological Health. Such report shall include information on the times required to log in and review original submissions and supplements, times required to review manufacturers’ replies to submissions, and times to approve or clear such devices. Such report shall contain the Secretary’s recommendations on any measures needed to improve performance including, but not limited to, the allocation of additional resources. 116 STAT. 1613Such report also shall include the Secretary’s specific recommendation on whether responsibility for regulating such devices should be reassigned to those persons within the Food and Drug Administration who are primarily charged with regulating other types of devices, and whether such a transfer could have a deleterious impact on the public health and on the safety of such devices.