Hello...A Query About Books on FDA regulation of Medical Devices

Hasit Seth

Advocate-Counsel at Bombay High Court - India

February 2018

Hello…A Query About Books on FDA regulation of Medical Devices

< 1 min reading time

I need the group’s help in recommending a few books that describe the FDA medical device regulation process as basic introductory to intermediate level of material. I have done an Amazon search, but I didn’t find very convincing options.

source: https://www.linkedin.com/groups/78665/78665-6372867812284723203

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Posted by Hasit Seth

Asked on February 23, 2018 12:00 am

319 views

like 15 comments

	Private answer Jason Sharkey You might get more responses if you are more specific about what part of the regulation you want to learn about. Do you want to learn about device classification? Types of approvals? Quality System Requirements? Marked as spam 1 like Report spam
	Private answer The FDA website is a very useful tool in itself. Marked as spam like Report spam
	Private answer Hasit Seth Thank you Jason. I need a book that gives an overview of the whole regulatory process. Later on would like to consider the aspects you mentioned in detail like classification, quality and types of approvals. I believe each of them deserves a book of their own. Marked as spam like Report spam
	Private answer Christopher Wood The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices https://g.co/kgs/PGueoQ or anything by Kim Trautman. Also look for FDA Guidance on Design Controls from FDA website. Marked as spam like Report spam
	Private answer Alberto Paduanelli FDA website is good enough, and if you are after CFR 21 part 820 it's all there.. Marked as spam 1 like Report spam
	Private answer Barry Fitch Also you may find the Quality System Compendium 3rd edition useful http://www.aami.org/productspublications/ProductDetail.aspx?ItemNumber=917 Marked as spam like Report spam
	Private answer Robert Christensen Read my book, FDA You Were WRONG! By Tate Publishing Co, 2012 Marked as spam like Report spam
	Private answer With all of the MDR-focused changes across the industry, you might consider not only spending time on the FDA website, but also adding a BSI or RAPS course to supplement your education. The FDA site isn't a particularly exciting read, but it will tell you what you need to know--and for free. Good luck! Marked as spam like Report spam
	Private answer I recommend looking at the many guidance documents on FDA’s web site. They are a bit wordy but very helpful. Marked as spam like Report spam
	Private answer You may want to start with CDRH Learn https://www.fda.gov/training/cdrhlearn/default.htm Marked as spam like Report spam
	Private answer Please have a look on CDRH Learn from FDA website, where you can get information from presentations that are posted. If you a good material of book, then please purchase the latest edition of US medical device regulation from RAC-RAPS. Marked as spam like Report spam
	Private answer Hasit Seth Thank you very much everyone. All your inputs are helpful and deeply appreciated. Marked as spam like Report spam
	Private answer Consider RAPS Fundamentals of US Regulatory Affairs Marked as spam like Report spam
	Private answer Robin C. Hart, Ph.D. The RAPS website has excellent reference books Marked as spam like Report spam
	Private answer If your interested and gainingFDA clearance is your goal message me and I’ll connect you with a sketch to launch group that has had exceptional success, in unheard of short time frames, executing clearance on medical devices. Marked as spam like Report spam

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