| Database |
Comments |
| 510(k)s--Premarket
Notifications |
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 are available via the web interface for more recent records. The
database is updated monthly. |
| Approved
PMAs--Premarket Approvals |
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.
This database may be searched by a variety of fields and is updated on a monthly basis. |
| Device
Listing Database |
This database contains a listing of medical devices in commercial
distribution by both domestic and foreign manufacturers. |
| Establishment
Registration Database |
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. |
| Good Guidance
Practice Documents (GGP) |
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.
|
| HHS Employee
Directory |
This directory includes all FDA employees. You may search by
title, first name, last name, organization, keywords, etc. |
| MAUDE
(Manufacturer and User Facility Device Experience) Database |
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. |
| Medical Device
Reports (Search) |
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. |
| Product
Classification Database |
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. |
| FDA
Recognized Consensus Standards Database |
This database allows you to search the Recognized Consensus
Standards by organization, standard type, product code, and
category. |
| Warning
Letters |
Because this page is under construction some of the links are incorrect,
if you want to search by company use Company
Warning Letters Index. |
