Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices
Information
Type
Proposed Rule
Regulated products
Medical Devices
Published
June 20, 2012
Last updated
June 20, 2012
Description
Document number 2012-15024. The Food and Drug Administration (FDA) is proposing to reclassify the implanted blood access device preamendments class III device into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)