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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. |
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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. |
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This is a searchable database of domestic establishments engaged in the
manufacture, preparation, propagation, compounding, assembly, or processing
of medical devices intended for human use and commercial distribution. Foreign
establishments may also register, but are not required to do so. |
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This
database contains a listing of medical devices in commercial distribution
by both domestic and foreign manufacturers. |
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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. |
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This
is a database of documents and their associated topics on the CDRH webpages.
You can search the database by a word in a document title or display a list
of documents sorted alphabetically by topic. |
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The
GGP database contains the current comprehensive list of all CDRH guidance
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. Links to the actual document are available for most
entries. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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