Drug GMPs
820 Quality Systems
Biological-Blood-Cell
Food Industry
Clinical Industry
Part 11 Systems
GMP Combos
Medical Device
Misc Parts
Combination Products
ICH Handbooks
Cosmetics
Laboratory
EU GMPs
Gift Certificates


Search

Medical Device Industry Handbooks

FDA Food and Drug Administration
FDA Code of Federal Regulations Mini-Handbooks!
Or Call 856-810-7331  Fax: 856-810-7339

Select below which handbook is right for you, and if not sure, please call our Regulatory Department at 856-810-1825 or email at sales@gmppublications.com

CFR Rule Changes by GXPNews
Medical Device Combination - Standard
1-933734-58-2

Good Clinical Practices (GCP) Regulations for Medical Devices

21 CFR and ICH Parts:

  • 11 - Electronic Records; Electronic Signatures
  • 50 - Protection of Human Subjects
  • 54 - Financial Disclosure by Clinical Investigators
  • 56 - Institutional Review Boards
  • 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
  • 812 - Investigational Device Exemptions
  • 814 - Premarket Approval of Medical Devices
  • 820 - Quality Systems Regulations
  • The 510k & Premarket Approval (PMA) Guidance Document

Quantity   1 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.80 $9.70 $8.90 $7.90
Quantity   
Part 50 - Protection of Human Subjects
1-933734-11-6
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $3.00 $2.90 $2.75
5 Book Minimum
Quantity   
Part 54 - Financial Disclosure by Clinical Investigators
1-933734-12-4
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $3.00 $2.90 $2.75
5 Book Minimum
Quantity   
Part 56 - Institutional Review Boards
1-933734-13-2
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $3.00 $2.90 $2.75
5 Book Minimum
Quantity   
Part 801 - Labeling - Medical Device
1-933734-42-6
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $3.00 $2.90 $2.75
5 Book Minimum
Quantity   
Part 803 - Medical Device Reporting
1-933734-43-4
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $3.00 $2.90 $2.75
5 Book Minimum
Quantity   
Part 806 - Medical Devices; Reports of Corrections and Removal
1-933734-44-2
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $3.00 $2.90 $2.50
5 Book Minimum
Quantity   
Part 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
1-933734-45-0
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $3.00 $2.90 $2.50
5 Book Minimum
Quantity   
Part 809 - In-Vitro Diagnostic Products
1-933734-46-9
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $3.00 $2.90 $2.50
5 Book Minimum
Quantity   
Part 810 - Medical Device Recall Authority
1-933734-47-7
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $3.00 $2.90 $2.50
5 Book Minimum
Quantity   
Part 812 - Investigational Device Exemptions
1-933734-48-5
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $3.00 $2.90 $2.50
5 Book Minimum
Quantity   
Part 814 - Premarket Approval of Medical Device
1-933734-49-3
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $3.00 $2.90 $2.50
5 Book Minimum
Quantity   
Part 820 - Quality System Regulations
1-933734-50-7
Quantity   1 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $3.20 $3.10 $3.00 $2.90 $2.70
Quantity   
Part 11 and 820
1-933734-06-X
Quantity   1 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $5.95 $5.85 $5.75 $5.45 $4.95
Quantity   
Part 11, 210/211 & 820
1-933734-52-3
Parts 11, 210/211 & 820 - The GMP Predicate Rules
Quantity   1 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $6.90 $6.80 $6.70 $6.50 $5.90
Quantity   
PMA and 510k Guidelines
978-1-935131-94-6
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $5.95 $5.85 $5.75 $5.45 $4.95
5 Book Minimum
Quantity   
Medical Device Quality Systems Manual with Part 820 and Audit Checklist
978-1-935131-06-9
Medical Device Quality System Manual with 21 CFR Part 820 and QSR Audit Check List
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $13.90 $13.80 $13.70 $12.90 $10.90
Quantity   
   
Medical Device QSIT Manual with Parts 11, 803, 806, 820 & 821
$9.90
978-1-935131-10-6
Medical Device QSIT Manual includes 21 CFR Parts 11, 803, 806, 820, 821, & QSIT Manual.
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $9.90 $9.70 $9.40 $8.50 $7.95
   
Part 820 US and Chinese Combination
$5.95
1-933734-78-7
Quantity
Quantity   1 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $5.95 $5.85 $5.75 $5.50 $4.95
   
Basic Medical Device QSIT with 820
$6.90
978-1-935131-17-5
Medical Device QSIT Manual includes 21 CFR Part 820 QSR
Quantity
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $6.90 $6.75 $6.25 $5.50 $4.50
Medical Device Quality Systems Manual with 11 & 820
978-1-935131-19-9
Medical Device Quality System Manual with 21 CFR Parts 11 & 820
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $12.90 $11.80 $11.70 $10.90 $8.90
Quantity   
Medical Device Quality Systems Manual with 820
978-1-935131-05-2
Medical Device Quality System Manual with 21 CFR Part 820
Quantity   2 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $11.90 $11.80 $11.70 $10.90 $8.90
Quantity   
Medical Device Quality Systems Manual with 11, 210/211 & 820
978-1-935131-07-6
Medical Device Quality System Manual with 11, 210/211 & 820 QSR
Quantity   5 - 99    100 - 249    250 - 499    500 - 999    1000+  
Price $15.90 $15.80 $15.70 $14.90 $10.90
Quantity   
Copyright©1998 - 2009 GMP Publications, Inc., FDA.COM and GXPNews
GMP Publications, Inc. P.O. Box 335, Medford, NJ 08055   856-810-7331   sales@gmppublications.com