![]() 107-250), established a comprehensive system for the regulation Start Printed 83of medical devices intended for human use. 105-115), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) ( Pub. 101-629), the Food and Drug Administration Modernization Act of 1997 (FDAMA) ( Pub. 94-295), the Safe Medical Devices Act of 1990 (SMDA) (Pub. 301 et seq.), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) ( 21 U.S.C. End Further Info End Preamble Start Supplemental Information SUPPLEMENTARY INFORMATION: I. Sharon Lappalainen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Start Further Info FOR FURTHER INFORMATION CONTACT: FDA is also exempting this device from the premarket notification requirement. The Food and Drug Administration (FDA) is classifying the electrocardiograph electrode, intended to acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram, into class II (special controls). Provide legal notice to the public or judicial notice to the courts.įood and Drug Administration, HHS. Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of The official SGML-based PDF version on, those relying on it for ![]() The material on is accurately displayed, consistent with While every effort has been made to ensure that Regulatory information on with the objective ofĮstablishing the XML-based Federal Register as an ACFR-sanctioned The OFR/GPO partnership is committed to presenting accurate and reliable ![]() Register (ACFR) issues a regulation granting it official legal status.įor complete information about, and access to, our official publications Informational resource until the Administrative Committee of the Federal This prototype edition of theĭaily Federal Register on will remain an unofficial ![]() Each document posted on the site includes a link to theĬorresponding official PDF file on. The documents posted on this site are XML renditions of published Federal Register, and does not replace the official print version or the official It is not an official legal edition of the Federal This site displays a prototype of a “Web 2.0” version of the dailyįederal Register. ![]()
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