Title |
Description |
Updated |
Advisory
Committee/Panel Meetings - CDRH |
This database contains information about upcoming
CDRH Advisory Committee and Panel meetings. Historical information
and links to summaries and/or transcripts are provided for recent past meetings. |
Frequently as items become available |
|
Good
Guidance Practices (GGP) |
The GGP database contains the current comprehensive
list of all CDRH guidance documents with links to the documents. The term
guidance document refers to documents prepared for CDRH
staff, regulated industry and the public that relate to the processing,
content, and evaluation of regulatory submissions; the design, production,
manufacturing, and testing of regulated products; or to the inspection
and enforcement procedures. |
Frequently as items become available |
|
CFR
Title 21 - Food and Drugs |
This database contains the most recent
revision from the Government Printing Office (GPO) of the Code of Federal
Regulations (CFR) Title 21 - Food and Drugs. You can search CFR Title 21
by entering a part and section number, selecting a CFR part number from
a drop down list, or by using a full text search. |
Annually |
|
Clinical
Laboratory Improvement Amendments (CLIA) |
This database contains the commercially
marketed in vitro test systems categorized by the FDA since January 31,
2000 and test categorized by the Centers for Disease Control and Prevention
(CDC) prior to that date. |
Monthly |
|
Device
Listing |
This database contains a listing
of medical devices in commercial distribution by both domestic and foreign
manufacturers. |
Monthly |
|
FDA
Certified Mammography Facilities |
A searchable listing by state and zip code of
all mammography facilities certified by the Food and Drug Administration
(FDA) as meeting baseline quality standards for equipment, personnel and
practices under the Mammography Quality Standards Act of 1992 (MQSA). |
Weekly |
|
IVD
Home Use Lab Tests (Over The Counter) Tests |
Searchable listing of Over-the-Counter tests (OTC) and collection
kits that have been cleared or approved by the FDA |
Monthly |
|
MAUDE
(Manufacturer and User Facility Device Experience) |
MAUDE data represents reports of adverse events
involving medical devices. The data consists of all voluntary reports since
June, 1993, user facility reports since 1991, distributor reports since
1993, and manufacturer reports since August, 1996. |
Quarterly |
|
MDR
(Medical Device Reporting) |
This database allows you to search the CDRH's
database information on medical devices which may have malfunctioned or
caused a death or serious injury during the years 1992 through 1996. |
No longer being updated |
|
NHRIC
(National Health Related Items Code) |
The National Health Related Items Code (NHRIC)
is a system for identification and numbering of marketed device packages
that is compatible with other numbering systems such as the National Drug
Code (NDC) or Universal Product Code (UPC). Those manufacturers who
desire to use the NHRIC number for unique product identification may apply
to FDA for a labeler code. This database contains NHRIC data retrieved
from records that date back 20 years. |
Annually |
|
Premarket
Approvals (PMA) |
Premarket approval by FDA is the required process
of scientific review to ensure the safety and effectiveness of all devices
classified as Class III devices. An approved Premarket Approval Application
(PMA) is, in effect, a private license granted to the applicant for
marketing a particular medical device. This database may be searched
by a variety of fields and is updated on a monthly basis. |
Monthly |
|
Premarket
Notifications (510(k)s) |
Medical device manufacturers are required to
submit a premarket notification or 510(k) if they intend to introduce a
device into commercial distribution for the first time or reintroduce a
device that will be significantly changed or modified to the extent that
its safety or effectiveness could be affected. This database of releasable
510(k)s can be searched by 510(k) number, applicant, device name or FDA
product code. Summaries of safety and effectiveness information is
available via the web interface for more recent records. The database
is updated monthly. |
Monthly |
|
Product
Classification |
This database contains medical device names and
associated information developed by the Center. It includes a three
letter device product code and a Device Class that refers to the level of
CDRH regulation of a given device. |
Monthly |
|
Establishment
Registration |
This is a searchable database of establishments
engaged in the manufacture, preparation, propagation, compounding, assembly,
or processing of medical devices intended for human use and commercial distribution.
Foreign establishments that export to the U.S are also required to register.
Note: This database is updated once a month. |
Monthly |
|
FDA
Recognized Consensus Standards |
This database consists of those national and
international standards recognized by FDA which manufacturers can declare
conformity to and is part of the information the Center can use to make
an appropriate decision regarding the clearance or approval of a submission.
Information submitted on conformance with such standards will have a direct
bearing on safety and effectiveness determinations made during the review
of IDEs, HDEs, PMAs, and PDPs. Conformance with recognized consensus
standards in and of itself, however, may not always be a sufficient basis
for regulatory decisions. |
Quarterly |
|
United
States Agents for Devices |
This database acts as an "electronic bulletin
board" for any person wishing to provide service as a United States
agent. The potential US Agent may enter his/her name, address, contact information
and area(s) of speciality. Foreign manufacturers many then search the information
to find a potential US Agent. The information in the database will not be
reviewed by FDA and should not be interpreted as endorsing any person on
the list, or as suggesting that the person is particularly trained or qualified
to act as a United States agent. |
Frequently as items become available |
|
X-Ray
Assembler Data |
Federal regulations require that an assembler
who installs one or more certified components of a diagnostic x-ray system
submit a report of assembly. This database contains the releasable
information submitted including Equipment Location, General Information
and Component Information. Note: Data does not include dental system installations. |
Annually |