FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
OFFICE OF COMPLIANCE
DIVISION OF ENFORCEMENT A
Effective Date: 07/08/2011
1. DIVISION OF ENFORCEMENT A (DKKWBC)
A. Enforces the Medical Device Amendments of 1976 including the Safe Medical Devices Act of 1990 and 1992 and the Radiation Control for Health and Safety Act of 1972 relating to general surgery; in vitro diagnostic, dental, ear, nose and throat; ophthalmic; urology; gastroenterology; general hospital; and obstetrics/gynecology devices.
B. Manages and coordinates activities associated with administrative and regulatory actions.
C. Develops, interprets, and issues policy guidance in response to specific requests from the medical device and electronic products industries, trade associations, other Federal agencies, other countries, State agencies, and the general public. Develops, reviews, and revises new and amended regulations including good manufacturing practices (GMPs) and standards for electronic products.
D. Plans, initiates, coordinates, and conducts medical device and electronic product inspections and investigations of manufacturers and their products. Reviews and evaluates design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.
E. Identifies the need for and directs the development of Compliance Policy Guides and programs to facilitate compliance by manufacturers. Develops, coordinates, reviews, and revises medical device industry GMP regulations. Develops and implements programs to ensure uniform interpretation and application of GMPs and recommends regulatory action when appropriate.
2. AUTHORITY AND EFFECTIVE DATE
The functional statements for this Division were approved by the Secretary of the Department of Health and Human Services on July 8, 2011.
(I, R, C)
OF CHANGE HISTORY
|Initial||07/08/2011||N/a||CDRH/OMO||Secretary of Health|
and Human Services