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Compliance Program
Manual for FDA Staff

PART VI

REFERENCES, ATTACHMENTS AND PROGRAM CONTACTS

A. APPLICABLE REFERENCES OR AIDS

1. Code of Federal Regulations, Title 21, Part 7, Subpart C, Recalls.

Code of Federal Regulations, Title 21, Part 11, Electronic Records and Electronic Signatures.

Code of Federal Regulations, Title 21, Part 800.55, Administrative Detention.

Code of Federal Regulations, Title 21, Part 809.10, Labeling For In Vitro Diagnostic Devices.

Code of Federal Regulations, Title 21, Part 820, Current Good Manufacturing Practices/Quality System Regulation.

1. Biotechnology Inspection Guide, Nov. 1991.

1. Classification Names for Medical Devices and In Vitro Diagnostic Products, HHS Publication No. (FDA) 91-4246, August 1995. This directory is organized by "keywords" in alphabetical order. The classification number (5 digit product code), class, and CFR regulation number is given for each entry listed. Refer also to:

1. AQL Inspector's Rule and Manual. This special purpose plastic slide rule that rigidly adheres to ANSI/ASQC Z-1.4 can be obtained from INFO P.O. Box 58, Stillriver, MA. 01467. Phone (978) 456-3848. Cost is approximately $25 plus shipping cost for rule and manual. Information regarding the AQL Inspector's Rule and Manual can be found at the following web site: http://www.aqlinspectorsrule.com.

1. Design Control Guidance for Medical Device Manufacturers, March 1996.
2. Compliance Guide for Laser Products, September 1985 (reprinted July 1989).
3. Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems, Dec. 1997.
4. Guidance for Medical Gloves, A Workshop Manual, Sept. 1996, FDA publication #96-4257.
5. IOM, Chapter 10, Reference Materials.
6. FDA Sterility Analytical Manual, August 1997, 3^rd Edition.
7. Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, August 4, 2000. Available from:

• A.National Technical Information Service (NTIS) - For information on the NTIS system please call CDRH F-O-D (see ) D. below) and request Shelf number 3799.

• B.Health Care & Industry Organizations - For a list of organizations that have agreed to assist in the distribution of this information please call CDRH F-O-D (see ) D. below) and request Shelf number 4799.

• C.World Wide Web (Internet) – FDA, CDRH, & ORA maintain World Wide Web (WWW) sites for easy access to information. The home page may be accessed via FDA’s home page at http://www.fda.gov. For additional information on the WWW site please call CDRH F-O-D (see ) D. below) and request Shelf number 1799.

• D.CDRH Facts-On-Demand (F-O-D) - This automated fax system allows anyone to obtain CDRH information, 24 hours a day, 7 days a week by calling 800-899-0381 or 301-827-0111 from a touch-tone telephone. For additional information on obtaining MDR documents from the CDRH F-O-D system please call CDRH F-O-D and request Shelf number 5799 from DSMA Facts (press 1 at first voice prompt [VP], 2 at second VP, then follow subsequent VPs).

The following sources may be referenced for further guidance regarding sterilization processes:

Food and Drug Administration:

Guideline on Validation of the Limulus Amebocyte Lysate Test as an End - Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices, December 1987.

A list of FDA recognized standards related to sterilization of devices may be found on the internet at www.fda.gov/cdrh/modact/steril.html.

Association for the Advancement of Medical Instrumentation (AAMI)

3330 Washington Blvd.

Arlington, VA 22201

1-800-332-2264

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ANSI/AAMI/ISO 10993-7) 1995 (AAMI TIR 19-1998 provides guidance supplementing ANSI/AAMI/ISO 10993-7.).

Contract sterilization for ethylene oxide (TIR 14) 1997.

Designing, testing and labeling of reusable medical devices for reprocessing in health care facilities: A guide for manufacturers (AAMI TIR No. 12) 1995.

Ethylene oxide sterilization equipment, process considerations, and pertinent calculations (TIR 15) 1998.

Medical devices - Validation and routine control of ethylene oxide sterilization - Requirements (ANSI/AAMI/ISO 11135) 1994.

Packaging for terminally sterilized medical devices (ISO 11607) 1997, Supplemented by AAMI TIR 22, Guidance on application of ISO 11607 (1998).

Principles of industrial moist heat sterilization (TIR 13) 1997.

Radiation sterilization – material qualification (TIR 17) 1998.

Sterilization of medical devices - Microbiological methods - Part 1: Estimation of bioburden on product (ANSI/AAMI/ISO 11737-1) 1995.

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process (AAMI/ISO 11737-2) 1998.

Sterilization of health care products - Requirements for validation and routine control- Industrial moist heat sterilization (ANSI/AAMI/ISO 11134) 1994.

Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization (ANSI/AAMI/ISO 11137) 1995.

Sterilization of health care products - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches. (ISO/TR 13409) 1996.

Federal Standard Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones, 9/11/92, Fed. Std. No. 209E.

ANSI/ASQ

American Society for Quality Control

611 East Wisconsin Avenue

Milwaukee, Wisconsin 53202

Z1.4-1993, Sampling Procedures and Tables for Inspection by Attributes. (This document supersedes MIL-STD-105E).

American Society for Testing and Materials (ASTM)

100 Barr Harbor Drive

West Conshohocken, Pennsylvania 19428-2959

Standard Guide for Integrity Testing of Porous Barrier Medical Packages, ASTM F1585-95.

Standard Terminology Relating to Barrier Materials for Medical Packaging, ASTM F1327-98.

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration, ASTM F1929-98.

Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission, ASTM D3078-94.

Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection, ASTM F1886-98.

Standard Test Methods for Failure Resistance of Unrestrained and Nonrigid Packages for Medical Applications, ASTM F1140-96.

Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method, ASTM D4991-94.

Standard Test Method for Leaks Using Bubble Emission Techniques, ASTM E515-95.

Standard Test Methods for Seal Strength of Flexible Barrier Materials, ASTM F88-94.

Parenteral Drug Association (PDA):

7500 Old Georgetown Road, Suite 620

Bethesda, Maryland 20814

Technical Monograph No. 1, Validation of Steam Sterilization Cycles, 1978.

Technical Monograph No. 2, Validation of Aseptic Filling for Solution Drug Products, 1980.

Technical Report No. 3, Validation of Dry Heat Processes Used for Sterilization and Depyrogenation, 1981.

Health Industry Manufacturers Association (HIMA)

1200 G Street, N.W.

Washington, D.C. 20005

HIMA Reference on Sterile Packaging, (HIMA Publication 93-7) 1993.

United States Pharmacopeia/National Formulary, USP 24, NF 19 (2000):

U. S. Pharmacopeial Convention, Inc.

12601 Twinbrook Parkway

Rockville, Maryland 20852

- Bacterial Endotoxins Test

- Biological Indicators

- Biological Indicator for Dry-heat

Sterilization, Paper Strip

- Biological Indicator for EO Sterilization,

Paper Strip

- Biological Indicator for Steam Sterilization,

Paper Strip

- Biological Indicator for Steam Sterilization, Self-contained

- Microbial Limit Tests

- Pyrogen Test (USP rabbit test)

- Sterilization and Sterility Assurance of Compendial Articles

- Sterility Tests

- Transfusion and Infusion Assemblies

ATTACHMENT A - CLASS I DEVICES EXEMPT FROM MOST OF THE QS/GMP REQUIREMENTS BY CLASSIFICATION REGULATIONS

ATTACHMENT B - ADVISORY LIST OF DEVICES THAT ARE INTENDED FOR SURGICAL IMPLANT OR SUSTAINING LIFE

ATTACHMENT B-1 - HIGH RISK DEVICES

ATTACHMENT C - MODEL WARNING LETTERS (Revised)

MODEL NAI & VAI POST-INSPECTION NOTIFICATION LETTERS

ATTACHMENT D - DECISION CHART - AUTHORITY TO REVIEW DESIGN CONTROL RECORDS

ATTACHMENT E - SUMMARY OF MDR REPORTING REQUIREMENTS

ATTACHMENT F - SUMMARY OF TRACKING REQUIREMENTS

ATTACHMENT G - SUMMARY OF CORRECTIONS AND REMOVALS REQUIREMENTS

1. Questions regarding Field Accomplishments & Compliance Tracking System:

1. CDRH Contacts

1. MDR Regulation Interpretation and Policy Questions:

j. Questions regarding aspects of sterilization technology should be directed to:

Sarah Mowitt Candace McManus

Division of Enforcement I, HFZ-323 Division of Enforcement II, HFZ-333

Office of Compliance Office of Compliance

Telephone: (301) 594-4595 Telephone: (301) 594-4618

1. Questions regarding Electronic Records and Electronic Signatures should be directed to:

Paul Motise Stew Crumpler

m. Questions regarding potential or proposed regulatory actions should be directed to

OC Case Experts

Louis Kaufman (HFZ-320) (301) 594-4598 Division of Enforcement I

Andrea Latish (HFZ-330) (301) 594-4611 Division of Enforcement II

Karen Stutsman (HFZ-340) (301) 594-4646 Division of Enforcement III

Device Panel Assignments

Anesthesiology Karen Stutsman

Cardiovascular Karen Stutsman

Chemistry Louis Kaufman

Dental Andrea Latish

Ear, Nose, and Throat Andrea Latish

Gastroenterology and Urology Andrea Latish

General and Plastic Surgery Louis Kaufman

General Hospital Andrea Latish

Hematology Louis Kaufman

Immunology Louis Kaufman

Microbiology Louis Kaufman

Neurology Karen Stutsman

Obstetrics and Gynecology Karen Stutsman

Ophthalmic Karen Stutsman

Orthopedics Karen Stutsman

Pathology Louis Kaufman

Physical Medicine Karen Stutsman

Radiology Louis Kaufman

Toxicology Louis Kaufman

1. FDA Web Sites:

1. FDA home page: http://www.fda.gov
2. ORA home page: http://www.fda.gov/ora/
3. CDRH home page: http://www.fda.gov/cdrh/
4. MDR: http://www.fda.gov/cdrh/mdr.html

• http://www.fda.gov/medwatch and click on "How to Report."

• http://www.fda.gov/medwatch/report/instruc.htm - Instructions for the Mandatory MedWatch Form, 3500A.

1. QSIT Guide: http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm
2. FDA Recognized Standards related to Sterilization of Medical Devices:

http://www.fda.gov/cdrh/modact/steril.html

3. The Biologics and Devices Intercenter Agreement:

http://www.fda.gov/oc/ombudsman/bio-dev.htm

h. Electronic Records and Electronic Signatures:

http://www.fda.gov/ora/compliance_ref/part11/

i. Field Accomplishments and Compliance Tracking System: http://web.ora.fda.gov/factsite/default.htm

j. Modernization Act and Tracking: http://www.fda.gov/cdrh/modact/tracking.html

k. Registration and Listing Database:

http://www.fda.gov/cdrh/comp/estregls.html

l. Electronic Product Radiation Requirements:

http://www.fda.gov/cdrh/radhlth/index.html

http://www.fda.gov/cdrh/reuse/index.shtml

n. Product Code Classification Database: http://www.fda.gov/cdrh/prodcode.html

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