Biomedical Engineering

A list of engineering data repositories evaluated according to the National Science and Technology Council "Desirable Characteristics of Data Repositories for Federally Funded Research", in association with the article "Engineering Data Repositories and Open Science Compliance: A Guide for Engineering Faculty and Librarians" presented at ASEE 2024 Conference.

Organizations such as the American Cancer Society, American Heart Association and many others support patients, their families and caregivers with information about the diseases, conditions, symptoms, treatments and background information. Searching Associations Unlimited or conducting a Google search will lead you to those resources.

Large Database for Marketing Research Studies with heavy emphasis in biotechnology, pharmaceuticals, healthcare, energy and other related sectors. Highly recommended.

Federal tracking agency for diseases, epidemics, pandemics, and health care for the general population.

Compiled by CDC to provide national and state level data and statistics on major medical conditions, including physician office visits and emergency department visits by diagnosed condition; also offers health care services, insurance cost & coverage and expenditures.

Searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other research institutions, maintained by the National Institutes of Health.

The CDRH is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products.

Federal regulatory commission for drugs and pharmaceuticals and medical devices.

Offers information about the NASA Space Biology Program and the Human Resource Program and related information sources including datasets, documents, biospecimens & other resources.

The NIH is the federal focal point for biomedical research in the U.S. Their web site includes funding opportunities and scientific resources and contact information for their offices and affiliates.

Provides outputs of scientific and engineering research in different categories.

Annual surveys conducted through 2004 that summarize a variety of issues important to like and work in Orange County, California

(UCI Access Only)
Business, economic and trade data from the U.S. Department of Commerce. Includes National Trade Data Bank (NTDB) and its foreign market research reports.

Also can be found in LL, Latest in Ref, HA 202 .U5.

Describes permits process for genetically-modified agricultural plants and animals.

Concordance of sources about different surgical practices from trusted sources of medical publishing.

Database contains mechanical, physical & biological responses as well as drug compatibility properties for the materials & coatings used in medical devices for cardiology/thoracic, orthopedics, neurological, and general surgery plus some coverage for urological, dental & anesthesiology. Includes FDA Emergency Use Authorized Devices ( including FDA EUA directives for latest COVID-related devices; Emergency Guidance Documents from FDA: EUAs, UK Medicines & Healthcare products Regulatory Agency, Australia's Therapeutic Goods Administration & Health Canada; latest FDA Approved devices (510(k) and PMA with links to associated materials, coatings & drugs noting producers, recalls and guidance documents.

Data USA is a comprehensive website and visualization engine of public US Government data and includes Viz Builder, and data about most sectors, industries, business, population/census, education, social indicators with allowances for maps and visualizations.

this agency is responsible for the regulatory passage of pharmaceuticals and medical devices.

Chapter 21 - Food and Drugs
Chapter 42 - Public Health
This is the official compilation of federal regulations.
Full print: LL REF KF 70 A3

GAO, 2009

The table contained in this link lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

This feature is provided to give a convenient way to search for all FDA guidance documents from a single location.

If you cannot find the document you’re looking for here, you can browse separate collections of guidance documents by topic.

Review of Regulatory Basics that includes videos on different aspects including Regulatory Pathways, Guidance for Mobile Medical Applications, and Regulatory Expertise.

Searches across multiple FDA Databases, including the device listing database,510(k) and PMA databases. Recommended for device classification coverage.

Lists the medical specialties used to review medical devices.

Enables users to classify a device based on the device name, review panel, regulation number, producy code, submission type, third-party eligibility and device class.

Database contains mechanical, physical & biological responses as well as drug compatibility properties for the materials & coatings used in medical devices for cardiology/thoracic, orthopedics, neurological, and general surgery plus some coverage for urological, dental & anesthesiology. Includes FDA Emergency Use Authorized Devices ( including FDA EUA directives for latest COVID-related devices; Emergency Guidance Documents from FDA: EUAs, UK Medicines & Healthcare products Regulatory Agency, Australia's Therapeutic Goods Administration & Health Canada; latest FDA Approved devices (510(k) and PMA with links to associated materials, coatings & drugs noting producers, recalls and guidance documents.

covers strategies for surgical gowns and masks, medical glove conservation, and ventilator supply mitigation

Reviews 4-step review process for pre-market approval.

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device.

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.

The 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.

This database includes:

medical device manufacturers registered with FDA and
medical devices listed with FDA

Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.

Database contains mechanical, physical & biological responses as well as drug compatibility properties for the materials & coatings used in medical devices for cardiology/thoracic, orthopedics, neurological, and general surgery plus some coverage for urological, dental & anesthesiology. Includes FDA Emergency Use Authorized Devices ( including FDA EUA directives for latest COVID-related devices; Emergency Guidance Documents from FDA: EUAs, UK Medicines & Healthcare products Regulatory Agency, Australia's Therapeutic Goods Administration & Health Canada; latest FDA Approved devices (510(k) and PMA with links to associated materials, coatings & drugs noting producers, recalls and guidance documents.