Research Guides: Biomedical Engineering: FDA Regulations

Classifying Your Device

Image from Arena Solutions, "How to Classify Your Medical Device for FDA Approval,"
https://www.arenasolutions.com/resources/articles/how-to-classify-your-medical-device-for-fda-approval/, accessed Aug 25, 2023.

The CDRH and the FDA provide guidelines for determining the classification of a medical device. There are three classes - I, II, and III - which are determined by risk and potential harm. Here's a video from the CDRH about classifying medical devices:

Most medical devices can be classified by finding the matching description of the device in Title 21 of the Code of Federal Regulations (CFR), Parts 862-892. FDA has classified and described over 1,700 distinct types of devices and organized them in the CFR into 16 medical specialty "panels" such as Cardiovascular devices or Ear, Nose, and Throat devices. These Classification Panels are listed by the FDA.

FDA Regulations

Unlike other areas of engineering, biomedical engineers often need to consider regulations from the United States Food & Drug Administration (FDA) that must be followed in order to move a product from the design phase to actual use on the market. On the FDA webpage for medical devices, which falls under the Center for Device and Radiological Health (CDRH), you can find lots of useful information, including the following:

CDRH News and Updates
Comprehensive List of Latest CDRH Updates
Medical Device Webinars and Stakeholder Calls
The FDA's Center for Devices and Radiological Health (CDRH) hosts webinars and calls to educate stakeholders on guidances, to answer technical questions on the development and validation of certain tests, and other topics related to the regulation of medical devices and radiation-emitting products. These forums provide the medical device industry and others with the chance to interact with FDA officials and have their questions answered.
Search for FDA Guidance Documents
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.
Search for Products and Medical Procedures
This webpage includes links to Recently-Approved Devices, 510(k) Premarket Notification Clearances, Premarket Approvals (PMA) for Class III Devices, and Humanitarian Device Exception (HDE) Approvals. Devices can also be found by purpose and specialty.
Search for Recognized Consensus Standards: Medical Devices
This database provides the most up-to-date list of voluntary consensus standards to which FDA will accept a Declaration of Conformity for medical devices.
Search the Releasable 510(k) Database
You can search the releasable 510(k) database by Panel, 510(k) Number, Product Code or Device Name.

UAB Libraries Holdings Related to Medical Devices

The UAB Libraries have many different kinds of information related to medical devices, including eBooks, peer-reviewed journal articles, regular publications like newsletters, etc. Below are a few examples of each - you can find more by searching on the library website or asking your Engineering Librarian for help!

eBooks Related to Medical Devices

Medical Device Technologies: A Systems Based Overview Using Engineering Standards by Gail Baura
Call Number: Electronic Book (Knovel)
Medical Device Technologies introduces undergraduate engineering students to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices.
Regulatory Affairs for Biomaterials and Medical Devices
by Stephen F. Amato (Editor); Robert M. Ezzell Jr (Editor)
Call Number: Electronic Book (Elsevier - unlimited user access | DRM-free)
All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world.
Medical Devices: Regulations, Standards and Practices
by Seeram Ramakrishna; Lingling Tian; Charlene Wang; Susan Liao; Wee-Eong Teo
Call Number: Electronic Book (Elsevier - unlimited user access | DRM-free)
Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards.
Medical Device Design: Innovation from Concept to Market
by Peter J. Ogrodnik
Call Number: Electronic Book (Elsevier - unlimited user access | DRM-free)
Medical Device Design: Innovation from Concept to Market, Second Edition provides the bridge between engineering design and medical device development. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace.
Class 1 Devices: Case Studies in Medical Devices Design
by Peter J. Ogrodnik
Call Number: Electronic Book (Elsevier - unlimited user access | DRM-free)
The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. This book is designed to complement Ogrodnik's Medical Device Design and will assist engineers with applying the theory in practice.

Peer Reviewed Journals Related to Medical Devices

European Medical Device Technology
Formerly "Medical Device Technology," this is a triannual peer-reviewed publication providing a comprehensive source of technical information on all aspects of the design, production and manufacture of finished medical devices and in vitro diagnostic (IVD) products. With in-depth applications-orientated articles and extensive product news, MDT magazine is a practical resource that helps European medical product designers, and manufacturing, regulatory and management staff do their jobs more effectively.
International Journal of Medical Device and Adjuvant Treatments
IJMDAT constantly publishes peer-reviewed, up-to-date results of basic and clinical research (basic research, prevention, public health, pharmacology and pharmacogenomics aspects, treatments, innovative aspects regarding diagnosis, pathology, pre-clinical and clinical experimental studies) related to the development and use of medical devices and adjuvant treatments.
Journal of Medical Devices
Published by ASME, the Journal of Medical Devices presents papers on medical devices that improve diagnostic, interventional and therapeutic treatments focusing on applied research and the development of new medical devices or instrumentation.
Medical Device Business Week
A weekly newsletter covering news, opinion, and commentary on medical equipment and technology.

UAB Resources for Research

If you are working on developing a medical device, you can reach out to the UAB Office of Research to discuss how they can help guide and manage your FDA-Regulated Research!

The UAB Center for Clinical and Translational Science may also be able to discuss regulatory issues and clinical research with your device.

Biomedical Engineering FDA Regulations

Classifying Your Device

FDA Regulations

UAB Libraries Holdings Related to Medical Devices

UAB Resources for Research