Instruct: Classify the given Amazon review into positive or negative sentiment.
Query: Insufficient detail to be of much use

The typesetting of this book makes it very difficult to read. It appears to be a scan of a typed page. In any event, although it does summarize some of the basics of medical device design such as design controls, the design file, submission of an IDE/510(k)/or PMA, it does not give enough detail to be of any use. The reader can get all of the information in this book from FDA guidance documents, which are free.