미, 2013년 3월 이전에 베리칩 시행?

미, 2013년 3월 이전에 베리칩 시행?

대법원 위헌 소송 중!

아래는 "오바마 헬스케어 법"이라고 불리우는

"New Health Care Law" 에 임플란트 칩이 규정된 부분,

이 헬스케어 법은 2010년 3월 21일 통과되고, 23일 싸인, 발효되었음.

헬스케어 법은 발효후 36개월 안에 시행될 것을 규정.

그렇다면, 2013년 3월 23일 안에 시행되어야 함,

그래서 2013년에 베리칩이 심어진다는 말이 있는 듯.

아래 헬스케어 법안에 임플란트 칩을 다룬 부분이 있는 것은 사실, 

그렇다고 2013년에 미국이 꼭 시행하게 될런지 어떨런지는 모르겠습니다.

현재 법안 전체에 대해 대법원에 위헌 소송중, 

New Health Care Law

H.R. 3200 section 2521, Pg. 1001, paragraph 1.

The Secretary shall establish a national medical device registry (in this subsection

referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data

on each device that? ‘‘is or has been used in or on a patient; ‘‘and is? ‘‘a class III device;

or ‘‘a class II device that is implantable, life-supporting, or life-sustaining.”

"Not later than 36 months after the date of the enactment"

a class II device that is implantable --> 여기에 베리칩이 포함됨, 자료 2) FDA 안내 참고,

자료 1) 2012년 3월 28일 / 헬스케어 법안, 미 대법원 위헌 소송중

대법원 오디오 (John Roberts/ Supreme court chief justice) 

지난 수요일 몇몇의 대법원 판사들은

오바마의 헬스 케어 법의 근간이 위헌이라고 판정을 해도,

법의 일부는 살아남을 수 있을 것이라고 전망하는 내용, 

전체를 위헌 판정하기 보다는, 부분 부분 쪼개서 조사해야한다는 입장.

Several Supreme Court justices seemed receptive Wednesday to the idea

that portions of President Barack Obama's health care law can survive even if the court declares the centerpiece unconstitutional. (March 28)

자료 2) "class II device" 에 대한 FDA 안내

아래 FDA 자료에서,

Implantable Radiofrequency Transponder System = RFID = Radio-frequency identification = 베리칩

즉, "class II device"라는 용어에 베리칩이 들어있습니다.

FDA 원문 : http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072141.htm

Guidance for Industry and FDA Staff

Class II Special Controls Guidance Document:Implantable Radiofrequency Transponder System for Patient Identification and Health Information

This guidance document was developed as a special control guidance to support the classification of the implantable radiofrequency transponder system for patient identification and health information into class II (special controls). The device is intended to enable access to secure patient identification and corresponding health information in humans . This guidance is issued in conjunction with a Federal Register notice announcing the classification of implantable radiofrequency transponder system for patient identification and health information.

This guidance document describes a means by which implantable radiofrequency transponder systems for patient identification and health information may comply with the requirement of class II special controls. Designation of this guidance document as a special control means that manufacturers of implantable radiofrequency transponder systems for patient identification and health information who follow the recommendations listed in this document, before introducing their device into commercial distribution in the United States, will also be able to market their device without being subject to the premarket notification requirements of section 510(k) of the Act.

Section 510(m) of the Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of this generic type of device if the manufacturer follows the recommendations in this special controls guidance or equivalent measures to address the risks identified in this guidance. Thus, persons who intend to market a device of this type do not need to submit a premarket notification to FDA and receive agency clearance prior to marketing the device, but as a class II device, the device must comply with the other applicable general and special controls (Section 513(a)(1)(B)).

Following the effective date of a final rule exempting the device, manufacturers of implantable radiofrequency transponder systems for patient identification and health information will need to address the issues covered in this special control guidance. The firm must show that its device addresses the issues of safety and effectiveness identified in this guidance, either by meeting the recommendations of this guidance or by some other means that provides equivalent assurances of safety and effectiveness.