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U.S. Government

The Code of Federal Regulations

When you need to check FDA regulations, this site, also from the House of Representatives, allows you to search by title and section number, word, and topic, among other alternatives.

The Federal Register For a variety of regulatory communications from FDA, from announcements of public meetings to publication of final regulations (such as the revised GMP), this searchable version of the Federal Register provides the complete text for volumes published after 1994.
U.S. Patent & Trademark Office Database Covers the period from January 1, 1976 to the most recent weekly issue date. The database consists of the full text of US patents (including utility, design, reissue, plant and SIR patents). The full text of a patent includes all bibliographic data, such as the inventor's name, the patent's title, and the assignee's name, as well as the abstract, the full description of the invention, and the claims.

Legislative

Thomas: U.S. Legislative Information

This site offers the fully searchable text of House and Senate bills as well as the full text of the Congressional Record.

The United States Code This browseable version of the U.S. Code from the House of Representatives gopher offers a quick way to find U.S. laws covering the device industry by title and section numbers (you'll generally want Title 21). If you need to do a search by keywords, the Cornell University Law School provides a searchable version.

FDA

The Food and Drug Administration's Home Page

The parent site of CDRH offers general agency information and access to other FDA centers and to the Office of Regulatory Affairs. And if you need titles and contact information for staff members, you can try searching the Health and Human Services directory.

FDA Warning Letters A searchable database of warning letters with results offered in .pdf format. To read these files, you must have Adobe Acrobat.
FDA's Electronic Reading Room Contains an index of frequently requested FDA documents (rendered here to cut down on the number of FOI requests the agency gets). Categories include compliance policy guides, enforcement reports, inspectors' technical guides, medical devices reports (MDRs), product approval listings, and warning letters.
 

CDRH

FDA's Center for Devices and Radiological Health The CDRH site is clearly the first stop for regulatory information. It includes a center overview, recent CDRH federal register notices, blue book memoranda, and much more. Contact information for each department and program area is provided on the CDRH Referral List.
Device Advice A self-help service from CDRH, is perhaps the best source of information for anyone entering the medical device market. The interactive program takes you step by step through everything you need to know and do to get your product on the market.
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.
Medical Device Approvals The majority of medical devices are cleared through the premarket notification process, a less rigorous process. Some devices are exempt from both processes. Only devices that have gone through FDA’s premarket approval process and were approved after May 12, 2000 are listed on this page.
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.
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.
Devices eligible for third-party review
 		This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program.
This database contains a listing of medical devices in commercial distribution by both domestic and foreign manufacturers.
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.
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.
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.
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.
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 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.
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.
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.
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.
Wireless Medical Telemetry Service Sets aside the frequencies of: 608 to 614 MHz, 1395 to 1400 MHz, and 1429 to 1432 MHz for primary or co-primary use by eligible wireless medical telemetry users.
 

Nongovernmental

NSSN: A National Resource for Global Standards

Provides US, foreign, regional, and international standards and regulatory documents for purchase or free download, when possible. Users can subscribe to the Standards Tracking and Automated Reporting (STAR) service, which notifies them via e-mail whenever a particular standard gets updated or altered.

RegSource Features links to regulatory news of interest to medical device manufacturers. A device industry directory offers information ranging from upcoming conferences and meetings to standards and GMPs. Links to FDA's Federal Register and Title 21 of the U.S. Code are also available. A searchable database of Federal Register notices, as well as information on regulatory forms and warning letters, is provided.