Originally Published MDDI January 2002
NEWS & ANALYSIS
A monthly review of new and notable additions to FDA's Web site.
This site provides information on the Medical Device Establishment Registration Master File, which contains the required information submitted by owner/operators of medical device establishments in accordance with Section 510 of the Federal Food, Drug and Cosmetic Act. A search mechanism is now available for Establishment Registration information and Device Listing information.
This site provides Powerpoint, PDF, and text versions of a presentation at the 2001 FDA Science Forum: Science Across the oundaries,Washington, DC, February 15–16, 2001. The presentation discussed nine changes to the U.S. Performance Standard for Diagnostic X-Ray Equipment intended to reduce unnecessary radiation emitted during fluoroscopy.
In May of 2001, FDA's Division of Mammography Quality and Radiation Programs (DMQRP) contracted with SciComm of Bethesda, MD, to conduct a nationwide survey of randomly selected mammography facilities. This survey was a follow-up to the one conducted in 1997 under the Interim Regulations. This site discusses the results of the survey.
FDA/CDRH Recommendations for EMC/ EMI in Healthcare Facilities
CDRH receives many inquiries from healthcare organizations, medical device manufacturers, clinicians, and the public seeking information about experiences with and prevention of electromagnetic interference (EMI) with medical devices. Of particular interest is the safe use of cellular and wireless communications equipment in the vicinity of medical devices. This site discusses CDRH's recommendations for minimizing the risks associated with medical device EMI and and promotes electromagnetic compatibility in healthcare facilities.
Regulations mandate that any establishment engaged in the manufacture, prep-aration, propagation, compounding, or processing of a drug or device imported into the United States must register with FDA and identify the name and address of the establishment and the name of the United States agent for the establishment. FDA is making this Web page available to help foreign device establishments identify potential United States agents. Persons wishing to make their services as a United States agent available may voluntarily enter information about themselves directly on the Web page. That information should be limited to: the name of person offering service as a United States agent; address; telephone or fax number; e-mail address; and information pertaining to any particular product lines or areas of interest (e.g., contact lens manufacturers, cardiovascular devices, etc.).
This site describes FDA's final rule that establishes the notification and recordkeeping requirements for persons exporting human drugs, biological products, devices, animal drugs, food, and cosmetics that may not be marketed or sold in the United States. These regulations implement recent changes in the statutory requirements applicable to certain exports, and also codify recordkeeping requirements for exports of products that cannot be marketed or sold in the United States generally. This rule is effective March 19, 2002.
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