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Medical Device Manufacturer Databases

 

The following databases are helpfull and can be of interest to medical device manufacturers:

 

Releasable 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.

 

Releasable PMAs : 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.

 

Releasable Establishment Registrations : 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.

 

Releasable Device Listings : This database contains a listing of medical devices in commercial distribution by both domestic and foreign manufacturers.

 

Product Codes : 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.

 

Topic Index : 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.

 

Good Guidance Practices : 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.

 

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.

 

Medical Device Reporting (MDR) : 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.

 

MAUDE : 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.

 

NHRIC (National Health Related Items Code) Database : 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.

 

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.

 

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.

 

Useful Sites

 

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