FDA Resources
FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.
- Center for Devices and Radiolgoical Health (CDRH)Responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.
- Devices@FDAsort by: Approval Date Device Name
Devices@FDA is a catalog of cleared and approved medical device information from fda. it includes links to the device summary information, manufacturer, approval date, user instructions, and other consumer information. - FDA Science and Research - Medical DevicesCDRH's Regulatory Science Program
- General Controls for Medical DevicesGeneral Controls are the basic provisions (authorities) of the May 28, 1976 Medical Device Amendments (hereafter referred to as the Amendments) to the Food, Drug and Cosmetic Act, that provide the FDA with the means of regulating devices to ensure their safety and effectiveness.
- MAUDE - Manufacturer and User Faciltiy Device ExperienceThe MAUDE database houses medical device reports submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
- Premarket NotificationEach person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).
- Product Classification DatabaseThis database includes:a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory information.
- Products and Medical ProceduresMedical devices range from simple tongue depressors and hospital gowns to complex programmable pacemakers and robotic surgical systems.
- Recognized Consensus StandardsThis database provides the most up-to-date list of voluntary consensus standards to which FDA will accept a Declaration of Conformity.
- TPLC - Toal Product Life CyclePremarket and Postmarket data about medical devices. It includes information about Device Classification Product Codes, Premarket Approvals (PMA), Premarket Notifications (510[K]), MAUDE Medical Device Adverse Event Reports, and CDRH Medical Device Recalls.
Industry and Market Information
- BCC Research This link opens in a new windowBCC Research provides objective, unbiased measurement and assessment of market opportunities with detailed market research reports.
- Emerging Markets Information Service (EMIS) This link opens in a new windowFormerly known as ISI Emerging Markets. Multilingual collection of news and information sources about the emerging markets of selected countries in Latin America, Europe, Asia, the Middle East, and North Africa. Includes full-text primary news sources, financial data, statistics, and legal information. U of I users may click the "Go" button under Guest Access to start using the database, OR register a personal account for a more customized experience.
- Market Research and American Business, 1935-1965 This link opens in a new windowCollection of proposals, pilot studies, advertisements, reports, memorandums, letters, and supporting material created by Ernest Dichter and the Institute for Motivational Research.
- IBISWorld This link opens in a new windowBusiness reports in five categories: industry market research, industry risk ratings, company research, global industry research, and economic and demographic data.
- Business Source Ultimate This link opens in a new windowProvides bibliographic and full text content, including indexing and abstracts for scholarly business journals back as far as 1886 and full text journal articles in all disciplines of business, including marketing, management, MIS, POM, accounting, finance and economics. The database full text content includes financial data, books, monographs, major reference works, book digests, conference proceedings, case studies, investment research reports, industry reports, market research reports, country reports, company profiles, SWOT analyses and more. Use Business Source Ultimate in the NEW EBSCO user interface.
No Institutional Licenses for these
- BiomedtrackerSource for real-time tracking of drug development
- MDDI QmedMedical Device + Diagnostic Industry (MD+DI) is a resource exclusively for original equipment manufacturers of medical devices and in vitro diagnostic products. The goal of MD+DI is to help industry professionals develop, design, and manufacture medical products that comply with complex and demanding regulations and market requirements.
Regulation
- Clinical Trials and Human Subject ProtectionFDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations.
- ClinRegsClinRegs is an online database of country-specific clinical research regulatory information designed to assist in planning and implementing international clinical research. Countries are included based on NIAID's international clinical research priorities.
- Health Canada Medical Device PortalFrom the Canadian Government.
- FDA Medical Devices Portaldirectory of databases covering all aspects of medical device development.
- EC Medical DevicesFrom the European Commission.