Device Approval

FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

I. Glenn Cohen, Holly Fernandez Lynch

Medical device quality assurance and regulatory compliance

Richard C. Fries.

Pharmaceutical Regulatory Documents: A Reference of Federal Documents Pertaining to Major Pharmaceutical, Medical Device, Sales, Manufacturing, Electronic ... Included, As An Aid to Compliance

Daniel Farb

Static and dynamic spinal implants: are we evaluating them appropriately?

guest editors, Laura M. Jensen ... [et al.].

Redirecting Innovation in U.S. Health Care: Options to Decrease Spending and Increase Value

Christopher Lau, Susan M. Gates, Mary E. Vaiana, Andrew W. Mulcahy, Arthur L. Kellermann, Emmert B. Keeler, Steven Garber

Development and control of medicines and medical devices

Robin J. Harman

Medical product regulatory affairs: pharmaceuticals, diagnostics, medical devices

by John J. Tobin and Gary Walsh

The regulation of medical products

edited by J.P. Griffin and J. O'Grady.

Medical device safety: the regulation of medical devices for public health and safety

Gordon R. Higson.

Guide to medical device registration in Japan

Yakuji Nippōsha