Reglera publishes handy reference booklets for the medical device and tissue industries. These reference booklets provide the updated regulations for each industry in an organized format. They are compiled to help answer questions and guide you through the details of FDA compliance. Our clients have found that this is a great desk reference and we would be glad to send one or more your way.

Send in the form below to order copies of the following booklets:

• 21 CFR Parts 210 & 211 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals
• 21 CFR Part 820 - Quality System Regulation
• 21 CFR 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
• Process Validation - Guidance on General Principles of Process Validation
• Design Control - Design Control Guidance for Medical Device Manufacturers
• 21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue- Based Products
• Eligibility Determination for Donors of HCT/Ps - Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue- Based Products (HCT/Ps)
• Current Good Tissue Practice - Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

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