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2 of 3 people found the following review helpful:
4.0 out of 5 stars
Excellent resource for medical device regulation,
By A Customer
This review is from: Fda Regulation of Medical Devices (Hardcover)
FDA Regulation of Medical Devices is an excellent overview of the history of medical device regulation and serves as an excellent training tool for regulatory professionals. It provides how-to instructions on filing IDE's 510(k)'s and PMA's with a checklist for all required components. Since the book was published in 1995, it does lack updated information regarding FDAMA and new FDA initiatives.
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Fda Regulation of Medical Devices by Bradley Merrill Thompson (Hardcover - July 1995)
Used & New from: $250.00
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