Department of Health and Human Services October 17, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: External Pacemaker Pulse Generator.'' This draft guidance document describes a means by which external pacemaker pulse generators may comply with the requirement of special controls for class II devices. This draft guidance is not final nor is it in effect at this time.
Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices
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).
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
