Contents

SUBCHAPTER 1020 - SPECIAL REGULATORY BY PRODUCT CATEGORY

1021 - FOOD AND COLOR ADDITIVES

1021.01 - Food Additives Status List

The Food Additives Status List in the IOM Appendix A is a quick look up of a number of food additives and their use limitations as specified in regulations 21CFR 170-199 and 21 CFR 570-589 promulgated under the FD&C Act, under Sections 401 (Food Standards) 409 (Food Additives) and 512 (Animal Drugs). You may encounter additives which are not in the IOM Appendix A but are still acceptable because they are:

1. Obviously safe substances although not on the list of items generally recognized as safe (GRAS), and not published in the regulations;
2. Synthetic flavoring substances because of their indefinite status;
3. Those pending administrative determination;
4. Substances granted prior sanction for specific use prior to enactment of the Food Additives Amendment;
5. Food contact substances (including secondary direct additives) that are the subject of an effective notification. For the inventory of effective notifications for food contact substances, see http://www.cfsan.fda.gov/~dms/opa-fcn.html

In addition to the IOM Appendix A, there are several FDA additive databases available on the FDA website. The FDA has published the EAFUS (Everything Added to Food in the United States) database. This list of substances contains ingredients added directly to food that FDA has either approved as food additives or listed or affirmed as GRAS. Nevertheless, it contains only a partial list of all food ingredients that may in fact be lawfully added to food, because under federal law some ingredients may be added to food under a GRAS determination made independently from the FDA. The list contains many, but not all, of the substances subject to independent GRAS determinations. For information about the GRAS notification program, consult the Inventory of GRAS Notifications.

See also food additive publications available from the FDA/CFSAN/Office of Food Safety.

1021.02 - Color Additives Status List

The Color Additives Status List in Appendix A provides the current status and use limitations of most colors likely to be found in food, drug, device, or cosmetic establishments. To access Color Additives for Medical Devices (11/95), see http://www.fda.gov/cdrh/ode/575.pdf. To access the FDA Color Additives web page see http://www.cfsan.fda.gov/%7Edms/col-toc.html.

1022 - FOOD

For up to date references on food, food additive and cosmetic requirements and guidance, periodically check the Center for Food Safety and Applied Nutrition's web site. See http://vm.cfsan.fda.gov/list.html.

For food and cosmetic guidance documents, see http://www.cfsan.fda.gov/~dms/guidance.html.

1022.01 - Food - General

1. Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed(Revised 8/00): Lists action levels for unavoidable poisonous or deleterious substances, which are established by the FDA to control levels of contaminants in human food and animal feed.
2. Allergens: CPG 555.250 FDA Statement of Policy on Labeling and Preventing Cross-Contact of Food Allergens (4/01)
3. BSE: Guidance for Industry: The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA Regulated Products for Human Use (9/97)
4. Botanicals: Letter to Manufacturers Regarding Botanicals and Other Novel Ingredients in Conventional Foods (1/01)
5. Defect Action Levels(Revised 5/98) - Lists levels of natural or unavoidable defects in foods that present no health hazards for humans
6. Filth in Food - Sec. 555.600 - Filth from Insects, Rodents, and Other Pests in Foods (CPG 7120.18) (12/02).
7. Food Code(Revised 2001): a compendium of model food safety guidelines for retail operations and institutions that is based on the latest science. The Food Code is used as a reference by the more than 3,000 state and local regulatory agencies that oversee food safety in restaurants, grocery stores, nursing homes, and other institutional and retail settings.
8. Fruits and Vegetables: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables; (10/98)
9. Frozen Dessert Processing Guidelines (10/89) - Available from CFSAN/Office of Field Programs/ Division of Cooperative Programs/Milk Safety Branch (HFS-626), Bob Hennes at 301-436-2175.
10. Health Claims: Guidance for Industry: Qualified Health Claims in Labeling of Conventional Foods and Dietary Supplements (12/02)
11. Labeling: Food Labeling Guide (6/99update)
12. Labeling: Food Labeling Questions and Answers Volume 1
13. Labeling: Food Labeling Questions and Answers Volume 2
14. Labeling: NLEA Small Business Exemption Criteria
15. Pesticides: Glossary of Pesticide Chemicals (10/01) lists Title 40 CFR tolerances of pesticide chemicals in food and animal feed -
16. Pesticides: Pesticide Residues in Food and Feed - Enforcement Criteria Sec. 575.100 (CPG7141.01) (Rev. 3/95)
17. Registration of Food Facilities
18. Security: Guidance for Industry -- Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance (3/03)
19. Security: Guidance for Industry -- Importers and Filers: Food Security Preventive Measures Guidance (3/03)
20. Security and Safety: FDA publications on CFSAN Food Safety and Security web page

1022.02 - Hazard Analysis Critical Control Points (HACCP)

1. Hazard Analysis and Critical Control Point (HACCP) Principles and Application Guidelines (8/97) See http://vm.cfsan.fda.gov/~comm/nacmcfp.html#execsum
2. HACCP Overview CFSAN web page http://www.cfsan.fda.gov/~comm/haccpov.html
3. Juice HACCP regulation - Questions and Answers, (8/01)See http://www.cfsan.fda.gov/~comm/juiceqa.html
4. Juice HACCP regulation - Additional Questions and Answers (9/03)
5. Juice HACCP Regulator Training (9/02) See http://www.cfsan.fda.gov/~comm/juiceman.html
6. Juice - Draft Guidance for Industry: Standardized Training Curriculum for Application of HACCP Principles to Juice Processing (6/03) See http://www.cfsan.fda.gov/~dms/juicgui5.html
7. Juice - Guidance for Industry: Bulk Transport of Juice Concentrate and Certain Shelf Stable Juices (4/03)
8. Draft Guidance for Industry: Juice HACCP Hazards and Controls Guidances, First Edition (9/02) See http://www.cfsan.fda.gov/~dms/juicgui3.html
9. Guidance for Industry: Exemptions from the Warning Label Requirements for Juice - Recommendations for Effectively Achieving a 5-Log pathogen Reduction (updated 10/02) See http://www.cfsan.fda.gov/~dms/juicgui6.html
10. Juice HACCP Small Entity Compliance Guide (4/03)
11. Juice HACCP CFSAN web page: for additional FDA juice HACCP publications, see http://www.cfsan.fda.gov/~comm/haccpjui.html#regulation
12. Seafood HACCP Guidance Fish and Fisheries Products Hazards and Controls Guidance, Third Edition, see http://www.cfsan.fda.gov/~comm/haccp4.html
13. Seafood HACCP Questions and Answers: HACCP Regulations for Fish and Fishery Products, See http://www.cfsan.fda.gov/~dms/qa2haccp.html
14. Seafood HACCP Transition Guidance (12/99) See http://www.cfsan.fda.gov/~comm/seaguide.html
15. Seafood HACCP Refusal of Inspection or Access to HACCP Records Pertaining to Safe and Sanitary Processing of Fish and Fishery Products Guidance (7/01) See http://www.cfsan.fda.gov/~comm/seaguid3.html
16. Seafood HACCP Domestic Seafood HACCP report, See http://www.cfsan.fda.gov/~dms/sea3501a.html
17. Seafood HACCP CFSAN web page See http://www.cfsan.fda.gov/~comm/haccpsea.html
18. Seafood Information and Resources: CFSAN web page >http://www.cfsan.fda.gov/seafood1.html#haccp

1022.03 - Bioengineered Foods

1. Center for Food Safety and Applied Nutrition, Biotechnology Home Page, See http://vm.cfsan.fda.gov/~lrd/biotechm.html
2. Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering - Draft Guidance (1/01) See http://vm.cfsan.fda.gov/~dms/biolabgu.html
3. Federal Register of 1/18/01, Premarket Notice Concerning Bioengineered Foods (1/01) See http://www.cfsan.fda.gov/~lrd/fr010118.html
4. Federal Register of 5/29/92, Statement of Policy: Foods Derived From New Plant Varieties, pp. 22984-23005 (10/00) See http://vm.cfsan.fda.gov/~lrd/bio1992.html
5. FDA's Policy for Foods Developed by Biotechnology; CFSAN Handout 1995 see http://www.cfsan.fda.gov/~lrd/biopolcy.html
6. FDA's Statement of Policy: Foods Derived from New Plant Varieties Questions & Answers 6/92 see http://vm.cfsan.fda.gov/~lrd/bioqa.html

1022.04 - Seafood

1. Seafood HACCP Guidance Fish and Fisheries Products Hazards and Controls Guidance, Third Edition (6/01) See http://www.cfsan.fda.gov/~comm/haccp4.html
2. Questions and Answers: HACCP Regulations for Fish and Fishery Products (1/99) See http://www.cfsan.fda.gov/~dms/qa2haccp.html
3. Seafood HACCP Transition Guidance (12/99) see http://www.cfsan.fda.gov/~comm/seaguide.html
4. Seafood HACCP Refusal of Inspection or Access to HACCP Records Pertaining to Safe and Sanitary Processing of Fish and Fishery Products Guidance (7/01) See http://www.cfsan.fda.gov/~comm/seaguid3.html
5. Domestic Seafood HACCP Report, Revised Instructions FDA Form 3501 (2/01) see http://www.cfsan.fda.gov/~dms/sea3501a.html
6. For more information on seafood HACCP see http://www.cfsan.fda.gov/~comm/haccpsea.html
7. Guidance Document for Trace Elements in Seafood -Arsenic, Cadmium, Chromium, Lead, Nickel (1993) see http://www.cfsan.fda.gov/~frf/guid-sf.html
8. National Shellfish Sanitation Program Model Ordinance (11/00): represents the Agency's current thinking on the safe and sanitary control of the growing, processing, and shipping of molluscan shellfish for human consumption, see http://vm.cfsan.fda.gov/~ear/nsspotoc.html
9. Interstate Certified Shellfish Shippers List, see http://vm.cfsan.fda.gov/~ear/shellfis.html
10. Seafood HACCP CFSAN web page: See http://www.cfsan.fda.gov/~comm/haccpsea.html
11. Seafood Information and Resources: CFSAN web page http://www.cfsan.fda.gov/seafood1.html#haccp

1022.05 - Food Inspection Guides

Food inspection guides are available from DFI. Also, see http://www.fda.gov/ora/inspect_ref/igs/iglist.html. They include:

1. Guidance on Inspections of Firms Producing Food Products Susceptible to Contamination with Allergenic Ingredients (8/01) See http://www.fda.gov/ora/inspect_ref/igs/allergy_inspection_guide.htm
2. Food Allergen Inspection Training for Regulators (10/01) see http://www.cfsan.fda.gov/~dms/alrgtrn.html
3. Guide to Nutritional Labeling and Education Act (NLEA) Requirements (2/95) See http://www.fda.gov/ora/inspect_ref/igs/nleatxt.html
4. Guide to Inspections of Computerized Systems in the in the Food Processing Industry (3/98) See http://www.fda.gov/ora/inspect_ref/igs/foodcomp.html
5. Guide to Inspections of Grain Product Manufacturers (7/03)
6. Guide to Inspections of Interstate Carriers and Support Facilities (4/95) See http://www.fda.gov/ora/inspect_ref/igs/icsf.html
7. Guide to Inspections of Miscellaneous Food Products Volume I (5/95) See http://www.fda.gov/ora/inspect_ref/igs/foodsp.html
8. Guide to Inspections of Manufacturers of Miscellaneous Food Products, Volume II (9/96) See http://www.fda.gov/ora/inspect_ref/igs/foodsp2.html
9. Guide to Inspections of Dairy Product Manufacturers (4/95) See http://www.fda.gov/ora/inspect_ref/igs/dairy.html
10. Guide to Inspections of Acidified Food Manufacturers (5/98) See http://www.fda.gov/ora/inspect_ref/igs/acidfgde.htm
11. Guide to Inspections of Low Acid Canned Food Manufacturers, Part 1 (11/96) Administrative Procedures and Scheduled Processes See http://www.fda.gov/ora/inspect_ref/igs/lacfpt1/lacfpt101.html
12. Guide to Inspections of Low Acid Canned Food Manufacturers, Part 2 Processes and Procedures (4/97) See http://www.fda.gov/ora/inspect_ref/igs/lacfpt2/lacfpt201.html
13. Guide to Inspections of Low Acid Canned Food Manufacturers, Part 3 Containers/Closures (11/98) http://www.fda.gov/ora/inspect_ref/igs/iglist.html
14. Guide to the Inspection of Aseptic Processing and Packaging for the Food Industry (02/01), currently only available in hardcopy
15. Guide to Trace Back of Fresh Fruits and Vegetables Implicated in Epidemiological Investigations (7/03) See http://www.fda.gov/ora/inspect_ref/igs/epigde/epigde.html

1022.06 - CFSAN Databases

1. Everything Added to Food in the United States (EAFUS) see http://www.cfsan.fda.gov/~dms/eafus.html
2. List of Indirect Additives Used in Food Contact Substances, see http://www.cfsan.fda.gov/~dms/opa-indt.html
3. Inventory of Effective Premarket Notifications for Food Contact Substances see http://www.cfsan.fda.gov/~dms/opa-fcn.html
4. Food Contact Substance Cumulative Daily Intake/Acceptable Daily Intake database, see http://www.cfsan.fda.gov/~dms/opa-edi.html. This database cites the regulation where a food contact substance appears.
5. Summary of all GRAS notices - see http://www.cfsan.fda.gov/~rdb/opa-gras.html
6. Partial List of Enzyme Preparations Used in Food (7/01) see http://www.cfsan.fda.gov/~dms/opa-enzy.html
7. Partial List of Microbial Derived Ingredients Used in Food (7/01) see http://www.cfsan.fda.gov/~dms/opa-micr.html
8. Summary of Color Additives Used in Foods, Drugs, Cosmetics, and Medical Devices

CFSAN Office of Management Systems (HFS-676) maintains an internal database of Low Acid Canned Food/Acidified Food registered establishments and scheduled processes. To gain access and further information about this database, ORA personnel should contact Sharon Macuci ORA/ORM at 301-436-1865.

1023 - DIETARY SUPPLEMENTS

To access the FDA's dietary supplement web site, see http://www.cfsan.fda.gov/~dms/supplmnt.html. References there include:

1. Dietary Supplement Health and Education Act of 1994 (12/95) synopsis
2. Dietary Supplement Overview of Dietary Supplements(4/99)
3. Ingredients: Premarket Notification for a New Dietary Ingredient (Federal Register, 9/23/97)
4. Ingredients: New Ingredients - Explanation including: definition, notification process, and table of notifications received (2/01)
5. Labeling Guidance for Industry: Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements (1/99)
6. Labeling Defining Structure/Function Claims That Can Be Used for Dietary Supplements, final Rule: Final Rule: Statements Made for Dietary Supplements Concerning the Effect of a Product on the Structure or Function of the Body (Federal Register, 01/06/2000)
7. Labeling Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements
   and Interim Evidence-based Ranking System for Scientific Data(7/03)
8. Labeling Guidance for Industry - Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements (1/99)
9. Labeling Guidance for Industry: Iron Containing Supplements and Drugs: Label Warning Statements (10/03)
10. Labeling Requirements to Use the Nutrient Content Claims "High Potency" and "Antioxidants". Final Rule: Food Labeling; Nutrient Content Claims: Definition for "High Potency'' and Definition of "Antioxidant'' for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods (Federal Register 9/23/97)
11. Labeling Letter Regarding Dietary Supplement Health Claim for Antioxidant Vitamins and Risk of Certain Cancers (4/03)
12. Consolidated Information on Ephedrine Alkaloids

1024 - COSMETICS

1024.01 - Cosmetic References

For FDA's Cosmetic web site see http://www.cfsan.fda.gov/~dms/cos-toc.html. Specific cosmetic references include:

1. Cosmetics Handbook(1992): FDA requirements and policies for safe production and accurate labeling of cosmetics
2. Cosmetic Good Manufacturing Practice Guidelines
3. FDA's Cosmetic Labeling Manual (10/91): Contains information on FDA's requirements and policies for safe production and accurate labeling of cosmetics.
4. Information Materials for the Food and Cosmetics Industries: A catalogue of cosmetic publications
5. Memorandum of Understanding (MOU) (6/03):
   Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Food Safety and Applied Nutrition to Assist FDA in Implementing the Drug and Cosmetic Provision of the Federal Food, Drug and Cosmetic Act for Products that Purport to be Cosmetics But Meet the Statutory Definition of a Drug
6. Microbiological Methods for Cosmetics (from FDA's Bacteriological Analytical Manual 8/01)

1024.02 - Cosmetic Inspection Guides

1. Cosmetic Guide to Inspections of Cosmetic Product Manufacturers (2/95) See http://www.fda.gov/ora/inspect_ref/igs/cosmet.html

1025 - DEVICES

1025.01 - CDRH Regulatory References

The Center for Devices and Radiological Health (CDRH), Division of Small Manufacturers Assistance (DSMA) (HFZ-220) maintains Fax Back, a fax on demand system to provide medial device related FDA references. The telephone numbers to access this system are (800) 899-0381 or (301) 827-0111. For up-to-date medical device references, see http://www.fda.gov/cdrh/index.html. See www.fda.gov/ora, the ORA home page for up-to-date medical device publications and guidance materials. For an alphabetized index of CDRH references, including product specific references, see http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/topicindex/topindx.cfm. One selection in the index is a list of Good Guidance Practices Documents, organized by issuing CDRH Office/Division/Branch.

References available from the CDRH fax information system or the CDRH web site include:

1. 510(k): 510(k) Manual Premarket Notification Regulatory Requirements for Medical Devices (8/95)
2. 510(k): Deciding When to Submit a 510(k) for a Change to an Existing Device (1/97)
3. 510(k) Sterility Review Guidance K90-1 Final Guidance for Industry and FDA (8/02)
4. 510(k): Medical Device Exemptions 510(k) and GMP Requirements (11/00)
5. 510(k): Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices (5/29/98)
6. Classification of Medical Devices: FDA Classification of Medical Devices
7. Classification of Medical Devices: Medical Device Product Code Classification Database
8. Consensus Standards: Guidance on the Recognition and Use of Consensus Standards (6/01)
9. Design: Design Control Guidance for Medical Device Manufacturers (3/97)
10. Design: Do it By Design an Introduction to Human Factors in Medical Devices See http://www.fda.gov/cdrh/humfac/doit.html (9/93)
11. Design: Device Use Safety: Incorporating Human Factors in Risk Management (7/00) See http://www.fda.gov/cdrh/humfac/1497.html
12. Design: New Model Medical Device Development Process (7/98)
13. Import Alerts on Medical Devices
14. IVD: Guideline for the Manufacture of In Vitro Diagnostic Products (1/94)
15. Labeling: Regulatory Requirements for Medical Device Manufacturers (8/89)
16. Labeling: Guidance for Industry: Alternative to Certain Prescription Device Labeling Requirements (1/00)
17. Labeling: Human Factors Principles for Medical Device Labeling (9/93)
18. MDR: Medical Device Reporting for Manufacturers (amended 3/00)
19. MDR: Medical Device Reporting for User Facilities (4/96)
20. MDR: Medical Device Reporting Forms and Instructions
21. MDR: Medical Device Reporting Alternative Summary Reporting (ASR) Program (10/00)
22. MDR: User Facility Reporting Bulletins
23. PMA: Premarket Approval Process
24. Quality Systems: Medical Device Medical Device Quality Systems Manual: A Small Entity Compliance Guide First Edition
25. Quality Systems: The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices". compiled by FDA/CDRH' Kimberly Trautman. The book offers guidance on the medical device QS/GMPs and shows their relationship to ISO 9001.
26. Registration: Guidance for Industry: Instructions for Completion of Medical Device Registration and Listing Forms 2891, 2891a and 2892
27. Registration and Listing: FOIA Releasable Registration and Listing Files
28. Re-use of Single Use: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals (8/00) and Appendix A updates (4/03)
29. Software: Final Guidance for Industry and FDA: General Principles of Software Validation (1/02)
30. Software: Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices (9/99)
31. Tracking: Guidance for Industry and FDA Staff on Medical Device Tracking (1/00)

1025.02 - Device Inspection Guides

Inspection guides covering medical devices are available from DFI (HFC-130) at 301-827-5653. Also see http://www.fda.gov/ora/inspect_ref/igs/iglist.html for guides to inspections of medical devices such as:

1. Guide to Inspections of Medical Device Manufacturers(12/97). See http://www.fda.gov/ora/inspect_ref/igs/med_dev_mnfct/toc.html
2. Guide to Inspections of Quality Systems (8/99) See http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm
3. Guide to Inspections of Foreign Medical Device Manufacturers (9/95) See http://www.fda.gov/ora/inspect_ref/igs/fordev.html
4. Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems (12/97) See http://www.fda.gov/ora/inspect_ref/igs/elec_med_dev/emc1.html
5. Mammography Quality Standards Act (MQSA) Auditor's Guide (1/98) See http://www.fda.gov/ora/inspect_ref/igs/mqsa.html
6. Guide to Bioresearch Monitoring Inspections of In Vitro Diagnostic Devices (3/98) See http://www.fda.gov/ora/inspect_ref/igs/bimoivd.html
7. Glossary of Computerized System and Software Development Terminology (8/95) See http://www.fda.gov/ora/inspect_ref/igs/gloss.html

1025.03 - CDRH Databases

For a list of and links to CDRH public access databases, see http://www.fda.gov/cdrh/databases.html. They include a searchable database of CDRH guidance documents, a listing of medical devices in commercial distribution, a database of registered firms, a listing of FDA - recognized consensus standards, and a product classification database. To access the CDRH public database of medical devices which may have malfunctioned or caused a death or serious injury during the years 1992 through 1997, see http://www.fda.gov/cdrh/mdrfile.html. The web site also contains a public database of the Device Experience Database (MAUDE) for a reports of adverse events involving medical devices since June 1993. To access the FDA internal registration and listing 510(k), PMA, MDR and Maude databases through the CDRH Information Retrieval System (CIRS) you must acquire an individual account by contacting your District CIRS liaison. See the ORA Field Program Monitors listing in the Chapter 2 of the IOM to locate your District CIRS liaison. To access the CDRH internal M204 data system on radiation-emitting electronic products, request the District computer liaison to contact the CDRH Office of Compliance for an account and instructions.

1026 - BIOLOGICS

1026.01 - CBER Regulatory References

A current listing of the Center for Biologics Evaluation and Research (CBER) regulatory references is available through CBER's web site.

For the topic index of CBER references, see http://www.fda.gov/cber/cberac.htm. For an index sorted by type of CBER publication, see http://www.fda.gov/cber/publications.htm. These references include:

1. IND Exemptions: Guidance for Industry: IND Exemptions for Studies of Drug or Biological Products for Treatment of Cancer (9/03)
2. Bioengineered Plants: Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (9/02) see http://www.fda.gov/cber/gdlns/bioplant.htm
3. Container Closure Systems: Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics-Chemistry Manufacturing Controls Documentation (7/99) see http://www.fda.gov/cber/gdlns/cntanr.htm
4. Human Tissue: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt Jakob Disease (CJD) and Variant Creutzfeld-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)(6/02) see http://www.fda.gov/cber/gdlns/cjdvcjd0602.htm
5. Human Tissue: Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation (3/02) see http://www.fda.gov/cber/gdlns/tissval.htm
6. Postmarket Adverse Experiences: Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products including Vaccines March 2001 See http://www.fda.gov/cder/guidance/4177dft.pdf
7. Sterile Products: Draft Guidance for Industry Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Process (8/03)

1026.02 - Blood and Blood Products Inspection

Guides and Industry Guidance

For a complete list of inspectional guides available from DFI, see http://www.fda.gov/ora/inspect_ref/igs/iglist.html. Blood and blood products inspection guides are:

1. Blood Bank Inspections (9/94) - See http://www.fda.gov/ora/inspect_ref/igs/blood.html
2. Source Plasma Establishments (4/01) - See http://www.fda.gov/ora/inspect_ref/igs/Source_Plasma/default.htm
3. Infectious Disease Marker Testing Facilities (10/96) See http://www.fda.gov/ora/inspect_ref/igs/infdis.html

CBER has mailed many guidance documents relative to Blood Banks directly to Blood Establishments. These guidance documents are listed in the Compliance Program Guidance Manual, Inspection of Licensed and Unlicensed Blood Banks. Also, to access these on the CBER Blood web page. They include:

1. Blood Components: Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components (10/02) See http://www.fda.gov/cber/gdlns/circbld.htm
2. Blood Components: Draft Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBSAg) Assays Used to Test Blood, Blood Components, and Source Plasma Donations (4/02) see http://www.fda.gov/cber/gdlns/hbslotrel.htm
3. Donors: Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients (12/02) See http://www.fda.gov/cber/gdlns/smpoxdefquar.htm#
4. Donors: Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection (5/03)
5. Donors: Guidance for Industry:Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires (7/03)
6. Donors: Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples of Donors of Whole Blood and Blood Components for Transfusion to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV (3/02) see http://www.fda.gov/cber/gdlns/hivhcvnatbld.htm
7. Donors: Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Produce Recipients and Their Contacts (12/99) see http://www.fda.gov/cber/gdlns/zooxeno.htm

1026.03 - Other Biologics Inspection Guides

1. Guide to Inspections of Viral Clearance Processes for Plasma Derivatives (3/98) See http://www.fda.gov/ora/inspect_ref/igs/viralcl.html
2. Biotechnology Inspection Guide (11/91) See http://www.fda.gov/ora/inspect_ref/igs/biotech.html

1026.04 - CBER Databases

1. Vaccine Adverse Event Report System (VAERS): a public access database of adverse events that occur after the administration of US licensed vaccines. Reports are received from: patients, parents, health care providers, pharmacists, and vaccine manufacturers
2. The Adverse Event Reporting System (AERS): a public access database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA receives adverse drug reaction reports from manufacturers as required by regulation. Health care professionals and consumers send reports voluntarily through the MedWatch program