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 |
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. |
Monthly |
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No longer being updated |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 |
Radiation-emitting Electronic Product Codes |
This database contains product names and associated information developed by the Center for all products, both medical and non-medical, which emit radiation. It includes a three letter product code, a descriptor for radiation type, applicable performance standard(s), and a definition for the code. |
Monthly |
Recalls
of Medical Devices |
This database contains a list of classified medical
device recalls since November 1, 2002 |
Frequently as items become available |
Registration & Listing |
This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution) and listings of medical devices in commercial distribution by both domestic and foreign manufacturers. 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 |
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 |