Legal Resources for the Health Sciences Guide
Resources and tools available to health sciences faculty, students, and staff.
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Legal Resources
Please note: UW Libraries staff are unable to provide legal advice.
This guide is intended as a starting place for researching legal topics related to the health sciences.
Regulations & Policies
Medical Devices
- Federal Drug Administration (FDA): Medical DevicesNavigate to the Device Registration and Listing Database, 510(k) Premarket Notification Database, Product Code Classification Database, and more.
- FDA: Overview of Device Regulation"The FDA issued the Quality Management System Regulation (QMSR) Final Rule, which amends the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes."The final rule is the latest action taken by the FDA to promote consistency in the regulation of devices. This action is intended to harmonize the FDA’s CGMP regulatory framework used by other regulatory authorities.
"The rule is effective February 2, 2026, two years after publication. Until then, manufacturers are required to comply with the QS regulation."
Drugs
- FDA: DrugsLinks to Drug Shortages database, National Drug Code Directory Search, Orange Book, and more.
Vaccines, Blood, and Biologics
- FDA: Vaccines, Blood & BiologicsLinks to Allergenics, Blood and blood products, Cellular and gene therapy products, Tissue products, and more.
Clinical Trials
- FDA: Good Clinical Practice and Clinical TrialsLinks to FDA Regulations relating to good clinical practice and clinical trials.
- See Institutional Review Board (IRB) section below
Health Insurance Portability and Accountability Act (HIPAA)
- UW Research: Policies, Procedures, and Guidance: HIPAA"This document provides guidance about the research use of protected health information (PHI), as governed by federal HIPAA regulations, WA state laws, and UW institutional policies."
- U.S. Department of Health and Human Services: Health Information PrivacyConsumer health guidance for HIPAA from the U.S. Department of HHS.
Institutional Review Board (IRB)
- UW Research: Human Subjects DivisionToolkit and guidance for conducting studies involving humans. Applies to surveying students as well as patients.
Institutional Animal Care and Use Committee (IACUC).
- UW Office of Animal WelfareLinks to grants and protocols, training, FAQs, and more related to animals as study subjects.
- National Institutes of Health (NIH): Office of Laboratory Animal WelfareDescribes the responsibilities of the IACUC.
State and Federal Laws
- Revised Code of Washington"Compilation of all permanent laws now in force" in Washington State.
- Federal Laws and Regulations"Research federal laws and the lawmaking process."
- Government PublicationsGuides and collections of government publications at the local, state, and federal levels. For help locating specific policies or other governmental proceedings, ask a Government Publications Librarian.
- Westlaw Campus ResearchFederal and state court cases, statutes, & regulations; law reviews & journals; legal research encyclopedias; and some international legal resources, company information, and news. Campus Research is not available to the law school or the office of the general counsel.
UW Libraries Resources
Health Sciences Resources
- EmbaseDatabase of biomedical literature with excellent drug and device search tools; includes information beyond journal articles, like conference proceedings.
Law Guides
Law Resources
- A-Z Law DatabasesUW Libraries-curated list of databases related to law.
- UW Gallagher Law LibraryHealth sciences students, faculty, and staff may visit the Law Library by appointment only.