DEVICE TRACKING.

SEC. 211. DEVICE TRACKING. Effective 90 days after the date of the enactment of this Act, section 519(e) (21 U.S.C. 360i(e)) is amended to read as follows: 111 STAT. 2346 “Device Tracking “(e)(1) The Secretary may by order require a manufacturer to adopt a method of tracking a class II or class III device— “(A) the failure of which would be reasonably likely to have serious adverse health consequences; or “(B) which is— “(i) intended to be implanted in the human body for more than one year, or “(ii) a life sustaining or life supporting device used outside a device user facility. “(2) Any patient receiving a device subject to tracking under paragraph (1) may refuse to release, or refuse permission to release, the patient’s name, address, social security number, or other identifying information for the purpose of tracking.”.