Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices
Information
Type
Proposed Rule
Regulated products
Medical Devices
Published
October 17, 2011
Last updated
October 17, 2011
Description
Document number 2011-26625. The Food and Drug Administration (FDA) is proposing to reclassify the external pacemaker pulse generator 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)