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11 of 12 people found the following review helpful:
3.0 out of 5 stars
OK, but I didn't "look inside this book",
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This review is from: Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration (Paperback)
Use the "look inside this book" function to review the table of contents, etc. I thought the book would include some information on FDA device approvals but it does not. This book is about manufacturing, FDA product inspections, when the FDA reviews compliance documentation at your factory, etc. Just be sure that is what you need.
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Inside This Book
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First Sentence:
This chapter of Mastering and Managing the FDA Maze: Medical Device Overview Training and Management Desk Reference discusses FDA laws, regulations, and medical device oversight. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
master verification plan, requirements control matrix, international conformance standard, device listing information, medical device oversight, document control matrix, adverse event report data elements, final acceptance checklist, approval cover sheet, design output specifications, design management oversight, significant additional study, device master record, premarket notification submission, medical device labeling, devices that fail, outpatient diagnostic facility, design history file, quality system role, inspectional strategy, verification test plans, management with executive responsibility, appropriate design controls, designated complaint unit, device history record Key Phrases - Capitalized Phrases (CAPs): (learn more)
Discussion Required, Title Review Manager, Quality System Inspection Technique, United States, Cosmetic Act, Federal Food, Discussion Don't, Office of Operations, Effective Date Note, Modernization Act, Subpart A-General Provisions Sec, Warning Letters, Code of Federal Regulations, Definitions Device, Batch Number, Definitions Design, Discussion Design, Item Number, Office of Compliance, Public Health Service Act, Subpart L-Handling, Subpart N-Servicing, Final Team, Subpart H-Acceptance Activities New!
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
This chapter of Mastering and Managing the FDA Maze: Medical Device Overview Training and Management Desk Reference discusses FDA laws, regulations, and medical device oversight. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
master verification plan, requirements control matrix, international conformance standard, device listing information, medical device oversight, document control matrix, adverse event report data elements, final acceptance checklist, approval cover sheet, design output specifications, design management oversight, significant additional study, device master record, premarket notification submission, medical device labeling, devices that fail, outpatient diagnostic facility, design history file, quality system role, inspectional strategy, verification test plans, management with executive responsibility, appropriate design controls, designated complaint unit, device history record Key Phrases - Capitalized Phrases (CAPs): (learn more)
Discussion Required, Title Review Manager, Quality System Inspection Technique, United States, Cosmetic Act, Federal Food, Discussion Don't, Office of Operations, Effective Date Note, Modernization Act, Subpart A-General Provisions Sec, Warning Letters, Code of Federal Regulations, Definitions Device, Batch Number, Definitions Design, Discussion Design, Item Number, Office of Compliance, Public Health Service Act, Subpart L-Handling, Subpart N-Servicing, Final Team, Subpart H-Acceptance Activities New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
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