Originally Published MDDI January 2002
NEWS & ANALYSIS
FDA Web Site Update
A monthly review of new and notable additions to FDA's Web site.
Center
for Devices and Radiological Health (CDRH) Freedom of Information (FOI) Releasable
Establishment Registration and Device Listing Files
http://www.fda.gov/cdrh/comp/estregls.html#files
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.
Estimated
Benefits of Proposed Amendments to the FDA Radiation-Safety Standard for Diagnostic
X-Ray Equipment
http://www.fda.gov/cdrh/radhlth/021501_xray.html
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.
Mammography
Facility Satisfaction Survey Highlights
http://www.fda.gov/cdrh/mammography/facsatsurv.html
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
http://www.fda.gov/cdrh/emc/emc-in-hcf.html
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.
United
States Agents for Devices Database
http://www.fda.gov/cdrh/usagent/
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.).
Exports:
Notification and Recordkeeping Requirements; Final Rule
http://www.fda.gov/OHRMS/DOCKETS/98fr/121901a.htm
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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