Code of Federal Regulation Handbooks by the FDA

Food & Drug Administration (FDA)

Code of Federal Regulations & ICH Handbooks

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Medical Device handbooks - Quantity Discounts Apply

801 Medical Device Labeling - $3.20 ea.
803 Medical Device Reporting - $3.20 ea.
806 Medical Device Reports of Corrections - $3.20 ea.
807 Estab. Registration and Device Listing... - $3.20 ea.
809 In-Vitro Diagnostic Products for Human Use - $3.20 ea.
810 Medical Device Recall Authority - $3.20 ea.
812 Investigational Device Exemptions - $3.20 ea.
814 Premarket Approval of medical Devices - $3.20 ea.

Medical Device handbooks in various combinations...

	Standard Medical Device Combination Handbook - 21 CFR Parts 11, 50, 54, 56, 807, 812, 814, 820, PMA & 510k - $9.90 each
	Custom Med. Dev. Combo. Handbook 1 - 21 CFR Parts 11, 50, 54, 56, 801, 803, 806, 807, 812, 814, 820, PMA & 510k Guidance Document & EU Medical Device Directive - 12.95 each
	Custom Med. Dev. Combo. Handbook 2 - 21 CFR Parts 11, 50, 54, 56, 801, 803, 806, 807, 812, 814, 820, PMA & 510k Guidance Document, & Canadian Medical Device Regulations & EU Medical Device Directive - 14.95 each
	EU - US Medical Device Handbook 3 - - 21 CFR Parts 11, 50, 54, 56, 801, 803, 806, 807, 812, 814, 820, EU Medical Device Directive, - 14.95 each

	Custom Med. Dev. Combo. Handbook 4 - 21 CFR Parts 11, 50, 54, 56, 801, 803, 806, 807, 812, 814, 820, PMA & 510k Guidance Document, Canadian Medical Device Regulations, EU Medical Device Directive & Inspection of Medical Device Manufacturers 7382.845 - 16.95 each

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