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El. knyga: Mastering and Managing the FDA Maze: Medical Device Overview

  • Formatas: 501 pages
  • Išleidimo metai: 18-Jul-2014
  • Leidėjas: ASQ Quality Press
  • Kalba: eng
  • ISBN-13: 9781636940465
Kitos knygos pagal šią temą:
Mastering and Managing the FDA Maze: Medical Device OverviewDidesnis paveikslėlis
  • Formatas: 501 pages
  • Išleidimo metai: 18-Jul-2014
  • Leidėjas: ASQ Quality Press
  • Kalba: eng
  • ISBN-13: 9781636940465
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A core book for a limited audience, this is the second edition of a comprehensive desk reference guide for those who need to do the complex paperwork of US Food and Drug Administration regulations on medical devices. The new edition reflects growth and change of regulation. It includes a new chapter addressing the newest FDA regulation, Part 830-Unique Device Identification. This regulation came in fall 2013 and will affect almost all device manufacturers over the next few years. Another new chapter looks at Part 806-Medical Devices; Reports of Corrections and Removals and what makers will need to do to comply with reporting requirements. Appendices have been updated to give current copies of a number of regulations, the References and List of FDA Offices have been updated to be current as of early 2014, and the acronym list and glossary has been expanded. Annotation ©2014 Ringgold, Inc., Portland, OR (protoview.com)
Figures and Tables
ix
Acknowledgments xi
What is New? xiii
Introduction xv
1 FDA Laws, Regulations, and Medical Device Oversight
1(30)
Scope
2(1)
FDA Laws
2(4)
FDA Regulations
6(7)
FDA Medical Device Oversight
13(18)
2 FDA Inspections
31(28)
Scope
32(1)
FDA Inspections
32(27)
3 Quality System Requirements, Management Responsibilities, and Personnel
59(16)
Scope
60(1)
Quality System
60(11)
Subpart B---Quality System Requirements
71(3)
FDA Inspection of Quality System Requirements
74(1)
4 Design Controls
75(50)
Scope
76(1)
Design Controls
76(41)
FDA Inspections of Design Controls
117(8)
5 Document Controls
125(10)
Scope
126(1)
Document Controls
126(7)
FDA Inspection of Document Controls
133(2)
6 Purchasing Controls
135(10)
Scope
136(1)
Purchasing Controls
136(3)
FDA Inspection of Purchasing Controls
139(6)
7 Identification and Traceability
145(6)
Scope
146(1)
Identification and Traceability
146(3)
FDA Inspection of Identification and Traceability
149(2)
8 Production and Process Controls
151(16)
Scope
152(1)
Production and Process Controls
152(12)
FDA Inspection of Production and Process Controls
164(3)
9 Acceptance Activities
167(8)
Scope
168(1)
Acceptance Activities
168(6)
FDA Inspection of Acceptance Activities
174(1)
10 Nonconforming Product
175(6)
Scope
176(1)
Nonconforming product
176(3)
FDA Inspection of Nonconforming product
179(2)
11 Corrective and Preventive Action
181(8)
Scope
182(1)
Corrective and Preventive Action
182(3)
FDA Inspection of Corrective and Preventive Action
185(4)
12 Statistical Techniques
189(6)
Scope
190(1)
Statistical Techniques
190(4)
FDA Inspection of Statistical Techniques
194(1)
13 Device Master Record (DMR)
195(10)
Scope
196(1)
Device Master Record (DMR)
196(7)
FDA Inspection of the Device Master Record
203(2)
14 Labeling and Packaging
205(16)
Scope
206(1)
Labeling
206(1)
Device Labeling
207(5)
Subpart K---Labeling and Packaging Control
212(4)
FDA Inspection of Labeling
216(1)
Packaging
217(2)
FDA Inspection of Packaging
219(2)
15 Handling, Storage, and Distribution
221(8)
Scope
222(1)
Handling
222(1)
FDA Inspection of Handling
223(1)
Storage
224(1)
FDA Inspection of Storage
225(1)
Distribution
226(1)
Subpart L---Distribution
226(1)
FDA Inspection of Distribution
227(2)
16 Installation and Servicing
229(8)
Scope
230(1)
Installation
230(2)
FDA Inspection of Installation
232(1)
Servicing
232(4)
FDA Inspection of Servicing
236(1)
17 Records---General Requirements, Device History Record (DHR), and Quality System Record (QSR)
237(14)
Scope
238(1)
Records
238(1)
Subpart M---General Requirements
239(3)
FDA Inspection of Records---General Requirements
242(1)
Subpart M---Device History Record (DHR)
243(2)
FDA Inspection of the Device History Record
245(1)
Quality System Record
246(4)
FDA Inspection of the Quality System Record
250(1)
18 Complaint Files
251(12)
Scope
252(1)
Complaint Files
252(9)
FDA Inspection of Complaint Files
261(2)
19 Unique Device Identification (UDI) System Including Applicable Parts of 21 CFR 830 and 21 CFR 801
263(42)
Scope
264(3)
Unique Device Identification
267(17)
FDA Inspection of Unique Device Identification
284(15)
FDA Inspection of Labeling
299(2)
FDA Accredited UDI Organizations
301(4)
20 Medical Device Reporting
305(18)
Scope
306(1)
Medical Device Reporting
306(17)
21 Medical Devices---Reports of Corrections and Removals
323(14)
Scope
324(1)
Reports of Corrections and Removals
324(10)
FDA Inspection of Corrections and Removals
334(3)
22 Quality Audit
337(14)
Scope
338(1)
Quality Audit
338(12)
FDA Inspection of Auditing
350(1)
Appendices
351(84)
A Part 820 -- Quality System Regulation
353(14)
B Part 801 -- Labeling
367(16)
C Part 830 -- Unique Device Identification
383(10)
D Part 803 -- Medical Device Reporting
393(18)
E Part 806 -- Medical Devices; Reports of Corrections and Removals
411(6)
F Part 807 -- Establishment Registration and Device Listing for Manufacturers and Distributors of Device
417(18)
References and List of FDA Offices 435(8)
Acronym List 443(6)
Glossary 449(18)
Index 467
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