Thursday, January 12th, 2012 - FDA
The noteworthy story of how the FDA’S Medical Device Amendment of 1976 forced a company out of business, leaving patients afflicted with Temperomandibular Joint Disorder without a much needed facial implant, can now be downloaded at no cost to the public.

Dr. Robert W. Christensen and Lynn M. Watwood, Esq. are releasing to the public their book, “FDA, You Were Wrong!” as a free download exclusively to the Kindle Owners’ Lending Library. Currently available on Amazon as a download, the book explains how, after a 40 year proven track record and success of a device to help patients with Temperomandibular Joint Disorder, section 510(k) of the 1976 Medical Device Safety Amendment prevented Dr. Christensen from continuing to produce the device and assist patients for 20 months during a protracted FDA review of a pre-amendment devices. An unclear interpretation of a rule allowed the FDA to penalize the company with a $630,000 Civil Money Penalty, which in effect caused the company to shut down operations.

The new rules put Dr. Christensen’s company out of business. After 40 years of successfully implanting the device, the regulations imposed on U.S. businesses have hampered growth and left many patients without any access to receive the surgery and obtain the device that would assist in alleviating the pain associated with the joint disease.

As the current political climate brings about debate regarding the role of government regulating, Dr. Christensen has said, “This has profound consequences for the future of medical device regulation.”

Go to Amazon to read Dr. Christensen’s eye-opening documentary. For an interview to discuss his controversial court battle and innovative medical devices, visit drbobchristensen.com or call 303-549-6674.

CONTACT:
Dr. Robert Christensen
P.O.BOX 80001-0443
303-549-6674

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Dr. Robert Christensen

P: 845-856-6852
W: www.drbobchristensen.com/index.html

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FDA, You Were Wrong

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