Library Guides: Biomedical Engineering: Medical Devices & FDA Regulations

FDA Regulatory Process

FDA - Center for Devices & Rediological Health
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.

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:

Device Class and Regulatory Controls

1. Class I General Controls

With Exemptions
Without Exemptions

2. Class II General Controls and Special Controls

With Exemptions
Without Exemptions

3. Class III General Controls and Premarket Approval

Device classification depends on the intended use of the device and also upon indications for use. Most Class I devices are exempt from Premarket Notification 510(k) (with the exception of Reserved Devices); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval (PMA).

FDA Product Classification Database
To find the classification of your device, as well as whether any exemptions may exist, you need to find the regulation number that is the classification regulation for your device. You can search for a part of a device name.
Device Classification Panels
To find the classification of your device, as well as whether any exemptions may exist, you need to find the regulation number that is the classification regulation for your device. If you know the medical specialty of your device, information on the corresponding regulations can be found here.

Medical Device Databases

510(k) Clearances
Monthly listings of new devices that have been shown to be "substantially equivalent" to devices that are already marketed legally for the same use.
Establishment Registration & Device Listing
This database includes medical device manufacturers registered with FDA and medical devices listed with FDA.
Evaluation of Automatic Class III Designation (De Novo) Summaries
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a "not substantially equivalent" (NSE) determination in response to a premarket notification [510(k)] submission.
MAUDE - Manufacturer and User Facility Device Experience
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.
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The data is also available in zipped files for downloading. The data in zip files is updated on a monthly basis.
Medical Device Databases
A list of all FDA Device Databases, such as: De Novo, Devices@FDA, Premarket Approvals, etc.
Medical Device Recalls
This database contains Medical Device Recalls classified since November 2002. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the FDA.
PMA Approvals
An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device.
Recently-Approved Devices
For each product, you can find information about what the device is, how it works, when it can be used, and when it should not be used.

Additional Resources

Journal of Medical Devices
Online Access to the Journal. Available since March 2007.
Engineering 360
Contains information on supply costs related to medical devices.
American Academy of Medical Ethics
The mission of the Academy of Medical Ethics is to promote the interests of medical educators, medical practitioners and scientists, the care and well-being of patients, the protection of public health, and the betterment of the medical profession, as well as to protect and promote the historical values that have provided the longstanding foundation for Western healthcare.
BMC Medical Ethics
BMC Medical Ethics is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies.

Penn State University Libraries

Biomedical Engineering

Finding Medical Devices Standards

Clinical Trials

Books on Medical Devices

FDA Regulatory Process

Medical Device Databases

Additional Resources