We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. We refer to these devices as postamendments devices because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).įDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by placing the device into a lower device class than the automatic class III assignment. Upon request, FDA has classified the spore test strip as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. 4506, Silver Spring, MD 20993-0002, End Further Info End Preamble Start Supplemental Information SUPPLEMENTARY INFORMATION: I. Start Further Info FOR FURTHER INFORMATION CONTACT:Ĭlarence Murray III, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. The classification was applicable on March 30, 2012. This order is effective February 14, 2022. We believe this action will also enhance patients' access to beneficial innovative devices. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. The special controls that apply to the device type are identified in this order and will be part of the codified language for the spore test strip's classification. The Food and Drug Administration (FDA, the Agency, or we) is classifying the spore test strip 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.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |