Academic Medical Law in the United States

Introduction to Academic Medical Centers

Medical Devices

In the U.S., medical devices are regulated by the Food and Drug Administration (FDA). The FDA posts lots of information about medical devices generally and about reporting on adverse affects of medical devices.

Directories: Medical device suppliers and their products are listed in the Medical Device Register, the Health Devices Sourcebook and MacRae’s Blue Book.

News: Good sources for medical device news include Mealey’s Emerging Drugs & Devices, Mealey’s Litigation Reports / Drugs & Medical Devices and the Gray Sheetwhich cover news about the regulation and marketing of medical devices. It’s also helpful to check the Diogenes FDA Regulatory Updates, the subscription-based FDAWebview and other general news databases. Another good option is the ESPICOM Pharmaceutical & Medical Device News database on ProQuest Dialog.

To get articles from Mealey’s publications, see “Mealey’s Litigation Reports.” The Gray Sheet is available through Pharma & MedTech Business Intelligence (formerly Elsevier Business Intelligence) and some subscription plans on Lexis (SCITEC;GRAY).

The Diogenes FDA Regulatory Updates database is available on available on ProQuest Dialog.

Premarket Notifications & Approvals: Companies are required to notify the FDA and get FDA approval before they can sell a new or significantly modified medical device.

If the device is supposed to be non-critical and substantially equivalent to devices manufactured prior to 1976, the manufacturer notifies the FDA by filing a Form 510(K). The FDA posts a database of summaries of the 510(K)s. Many of the summaries link to a PDF version of the full 510(K). Otherwise, you can get 510(K)s from FOI Services(301-975-9400).

If the device “supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury” then the device may require a full scientific review before it can receive Pre-Market Approval (PMA) from the FDA. The FDA posts a database of PMA approvals. You can get the FDA’s Summary of Safety and Efficacy (SS&E) along with the approval letter and labeling from FOI Services (301-975-9400).

Safety: You can find reports of adverse effects involving medical devices using the private Device Matters web site and the FDA’s MAUDE and MDR databases.

Warning Letters: FDA Warning Letters are available on the FDA Web site and through a number of Thompson subscription products, including the FDA Enforcement Manual. On a related note, you can look up medical devices seized under the 1906 Pure Food and Drug Act between 1906-1963 using the FDA Notices of Judgment Collection.

Resources

See Also

Medical Materials
Mealey’s Litigation Reports

Further Reading

• Information about Academic Medical Law in the Gale Encyclopedia of American Law.