**[PART VI]{.underline}**

**[REFERENCES, ATTACHMENTS AND PROGRAM CONTACTS]{.underline}**

**A. [APPLICABLE REFERENCES OR AIDS]{.underline}**

1\. [Guide to Inspections of Quality Systems]{.underline}, August 1999.

2.  Code of Federal Regulations, Title 21, Part 7, Subpart C,
    [Recalls]{.underline}.

> Code of Federal Regulations, Title 21, Part 11, [Electronic Records
> and Electronic Signatures]{.underline}.
>
> Code of Federal Regulations, Title 21, Part 16/17, [Hearing
> Procedures]{.underline}.
>
> Code of Federal Regulations, Title 21, Part 800.55, [Administrative
> Detention]{.underline}.
>
> Code of Federal Regulations, Title 21, Part 803, [Medical Device
> Reporting]{.underline}.
>
> Code of Federal Regulations, Title 21, Part 806, [Reports of
> Corrections and Removals]{.underline}.
>
> Code of Federal Regulations, Title 21, Part 807, [Establishment
> Registration and Device Listing]{.underline}.
>
> Code of Federal Regulations, Title 21, Part 809.10, [Labeling For In
> Vitro Diagnostic Devices]{.underline}.
>
> Code of Federal Regulations, Title 21, Part 810, [Medical Device
> Recall Authority]{.underline}.
>
> Code of Federal Regulations, Title 21, Part 820, [Current Good
> Manufacturing Practices/Quality System Regulation]{.underline}.
>
> Code of Federal Regulations, Title 21, Part 821, [Tracking
> Requirements]{.underline}.
>
> Code of Federal Regulations, Title 21, Parts 1000 -- 1050, [Radiation
> Regulations and Standards]{.underline}.
>
> 3\. [Federal Food, Drug, and Cosmetic Act, As Amended, February,
> 1998]{.underline}.

4\. [Investigations Operations Manual - Chapter 5, Subchapter
550]{.underline}.

5.  [Biotechnology Inspection Guide]{.underline}, Nov. 1991.

> 6\. [Medical Device Quality Systems Manual: A Small Entity Compliance
> Guide]{.underline} (HHS Pub. No. FDA 97-4179, Dec. 1996).

7\. NBS special Publication 250 - May 1984 (or update) [Calibration and
Related Measurement Services,]{.underline} U.S. Dept. of Commerce NBS,
Washington, D.C. 20234.

8\. [Guideline on General Principles of Process Validation]{.underline}:
Notice of Availability published in the Federal Register on May 1987.

9\. [Intercenter Agreement Between the Center for Biologics Evaluation
and Research and the Center for Devices and Radiological
Health]{.underline}, October 31, 1991.

10\. [Software Development Activities]{.underline}, July 1987.

11\. [Glossary of Computerized System and Software Development
Terminology]{.underline}, August 1995.

12\. [Quality Control Handbook]{.underline}, Juran, J.M., 5th edition,
McGraw-Hill, 1999.

13\. [ANSI/ASQC Z-1.4]{.underline} (Replaces MIL-STD 105E), [ANSI/ASQC
Z-1.9]{.underline} (Replaces MIL-STD 414) [Sampling Procedures and
Tables for Inspection by Attribute]{.underline}.

14\. [COMSTAT Guidance- Field and Centers]{.underline}: September 15,
1998.

15. [Classification Names for Medical Devices and In Vitro Diagnostic
    Products]{.underline}, 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:

> <http://www.fda.gov/cdrh/prodcode.html>[.]{.underline}

16\. [Advisory List of Critical Devices]{.underline} - 1988; Notice
Published in the Federal Register on March 17, 1988.

17\. [Overview of Metallic Orthopedic Implants]{.underline}; Technical
report, reference material and training aid for investigators prepared
by the Division of Emergency and Investigational Operations (HFC-132),
Office of Regional Operations, Office of Regulatory Affairs, HHS, Public
Health Service, FDA, June, 1988.

18. [AQL Inspector\'s Rule and Manual]{.underline}. 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](http://www.aqlinspectorsrule.com/).

19\. [Medical Device Reporting for Manufacturers]{.underline}, March
1997.

20\. [Do It By Design]{.underline}: Design Control Guidance.

> 21\. [The FDA and Worldwide Quality Systems Requirements Guidebook for
> Medical Devices]{.underline}, Compiled by Kimberly Trautman, ASQC
> Quality Press, Milwaukee, Wisconsin.

22. [Design Control Guidance for Medical Device
    Manufacturers]{.underline}, March 1996.

23. [Compliance Guide for Laser Products]{.underline}, September 1985
    (reprinted July 1989).

24. [Guide to Inspections of Electromagnetic Compatibility Aspects of
    Medical Device Quality Systems]{.underline}, Dec. 1997.

25. [Guidance for Medical Gloves]{.underline}, A Workshop Manual, Sept.
    1996, FDA publication #96-4257.

26. [IOM, Chapter 10, Reference Materials]{.underline}.

27. [FDA Sterility Analytical Manual]{.underline}, August 1997, 3^rd^
    Edition.

28. Guidance for Industry and for FDA Staff: Enforcement Priorities for
    Single-Use Devices Reprocessed by Third Parties and Hospitals,
    August 4, 2000. Available from:

> <http://www.fda.gov/cdrh/reuse/index.shtml>[.]{.underline}
>
> Copies of CDRH QS/GMP publications are available from the Division of
> Small Manufacturers Assistance (DSMA), Telephone: 800-638-2041 or FAX
> 301-443-8818.

**Sources to purchase these documents:**

-   **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.

    **Sources to obtain copies free of charge:**

-   **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).

A. 1. [APPLICABLE REFERENCES OR AIDS -- SPECIFIC TO
STERILIZATION]{.underline}

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.

[Sterile Medical Devices. A GMP Workshop Manual]{.underline}, Fourth
Edition November 1984. Prepared by Division of Small Manufacturers
Assistance, Office of Training and Assistance, HHS Publication FDA
84-4174.

Sterilization: Questions and Answers, January 1985.

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](http://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

**B. [ATTACHMENTS]{.underline}**

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

**C. [PROGRAM CONTACTS]{.underline}**

1\. [ORA Contacts]{.underline}

a\. Questions regarding [inspectional requirements and/or technical
assistance]{.underline}:

Division of Emergency & Investigational Operations

Medical Device Group, 301-827-5645

b\. Questions about accessing or connecting to the CDRH Center
Information Retrieval System (CIRS) call:

**CDRH Help Desk**

**(301) 594-4550, EXT. 104**

> **An easy method for Field Users to access the system is to log on to
> the regional VAX, then type:**

**TELNET apps \<return\>**

**Field Users should set up their communication program to emulate a
VT100 or other option before logging onto the Regional VAX.**

> NOTE: To obtain a CIRS account contact your local (district or
> regional) CIRS Liaison. Contact your SIMS/IRM for guidance on how to
> connect to CIRS.

c\. Questions regarding [sampling of devices and laboratory
capabilities]{.underline}:

Division of Field Science (DFS), HFC-140

Telephone: (301) 827-7605

d\. The [WEAC contact points]{.underline} for testing medical devices
is:

Laurence Coyne, Ph.D.

Director, Engineering Branch, HFR‑NE480

Telephone: (781) 729‑5700, ext. 761

Martin J. Finkelson

Director, Analytical Branch, HFR‑NE460

Telephone: (781) 729‑5700, ext. 749

e\. Questions regarding COMSTAT

Gillie Kovalsky

Medical Products Quality Assurance Staff (MPQA), HFC-240

Telephone: (301) 827-0390

f.  Questions regarding Field Accomplishments & Compliance Tracking
    System:

> See FDA Web Site:
> <http://web.ora.fda.gov/factsite/People/V2_HQ_Ctr_Cdr.htm>

2\. [District Office Contacts For Industry Management Concerns About
Their QS/GMP Compliance Status\*.]{.underline}

Atlanta Barbara Wood

Baltimore Lee Bowers

New England David Elder

Chicago Richard Harrison

Cincinnati Carol Heppe

Dallas Reynaldo Rodriquez

Denver Howard Manresa

Detroit David Kaszubski

Kansas John Thorsky

Los Angeles Thomas Sawyer

Minneapolis Edwin Dee

New Orleans Richard Debo

New Jersey Ray Abrahams

New York Edward Thomas

Florida David Gallant

Philadelphia Dorothy Miller

San Francisco Darrell Lee

San Juan Daniel Gonzalez

Seattle Russell Gripp

Foreign Firms Marje Hoban (CDRH)

\*In the event of a personnel change, contact the Director of Compliance
Branch or equivalent.

3.  [CDRH Contacts]{.underline}

> **NOTE**: See the CDRH/OC Organizational Structure at the end of Part
> VI to identify which unit within OC is responsible for answering your
> question or giving you guidance, depending on the type of device.

a.  MDR Regulation Interpretation and Policy Questions:

    Reporting Systems Monitoring Branch, HFZ-533

> Division of Surveillance Systems, OSB
>
> Telephone: (301) 594‑2735
>
> Data retrieval of MDR reports:

Information Analysis Branch, HFZ-531

> Division of Surveillance Systems, OSB

Telephone: (301) 827‑7537

> b\. [Industry MDR Report]{.underline}: (301) 427-7500. This telephone
> number should be used to request permission to submit a report by
> facsimile. Do not call this phone number to make inquiries or to
> submit a report by telephone.

c\. Questions regarding sampling and/or testing of **general medical**
devices.

> William Regnault
>
> Division of Mechanics and Material Sciences, HFZ‑150
>
> Telephone: (301) 827‑4748

d\. [Express Mail Address for All Regulatory Action
Recommendations]{.underline}:

> Field Programs Branch, HFZ-306
>
> Office of Compliance
>
> Center for Devices and Radiological Health
>
> 2094 Gaither Road
>
> Rockville, Maryland 20850

e\. [Questions regarding the interpretation and applicability of the
device Quality System regulation and GMP exemptions]{.underline}:

Kimberly A. Trautman

> Quality Systems/GMP Expert, HFZ-340
>
> Telephone: (301) 594-4648 ext.126
>
> or,

Contact the appropriate Division/Branch in the Office of Compliance for
the subject device.

f\. [Questions regarding remanufacturing, refurbishing/reconditioning of
used devices]{.underline}:

Wes Morgenstern

> Division of Program Operations, HFZ-305
>
> Telephone: (301) 594-4699 ext. 102

g\. [Questions regarding the reprocessing of single use
devices]{.underline}:

Larry Spears

> Division of Enforcement III, HFZ-340
>
> Telephone: (301) 594-4646 ext. 153

h\. [Questions regarding this Compliance Program]{.underline}:

Allen Wynn

Field Programs Branch, HFZ-306

> Telephone: (301) 594-4695 ext. 115
>
> Fax: (301) 594-4715

i\. [Questions regarding compliance of product software, stand alone
software, process equipment software or the Year 2000
Problem:]{.underline}

Stewart Crumpler

> Office of Compliance Software Expert, HFZ-340
>
> Telephone: (301) 594-4659 ext. 119

j\. [Questions regarding aspects of sterilization technology should be
directed to]{.underline}:

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

k.  [Questions regarding Electronic Records and Electronic Signatures
    should be directed to]{.underline}:

    Paul Motise Stew Crumpler

> ORA/Office of Enforcement Division of Enforcement III
>
> HFC-240 HFZ-340
>
> Telephone: (301) 827 0383 Telephone: (301) 594-4646 ext. 119

l\. Questions regarding Field Accomplishments and Compliance Tracking
System should be directed to the training cadre. For a listing of cadre
members refer to
[http://web.ora.fda.gov/factsite/People/V2_HQ_Ctr_Cdr.htm.]{.underline}

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

[the appropriate CDRH/OC Case Expert]{.underline}:

**[OC Case Experts]{.underline}**

> 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]{.underline}**

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

4.  [FDA Web Sites]{.underline}:

```{=html}
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```
a.  FDA home page: [http://www.fda.gov](http://www.fda.gov/)

b.  ORA home page: <http://www.fda.gov/ora/>

c.  CDRH home page: <http://www.fda.gov/cdrh/>

d.  MDR: <http://www.fda.gov/cdrh/mdr.html>

-   <http://www.fda.gov/medwatch> and click on \"How to Report.\"

```{=html}
<!-- -->
```
-   <http://www.fda.gov/medwatch/report/instruc.htm> - Instructions for
    the Mandatory MedWatch Form, 3500A.

e.  QSIT Guide:
    <http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm>

f.  FDA Recognized Standards related to Sterilization of Medical
    Devices:

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

g.  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>
>
> m\. Guidance for Industry and for FDA Staff Enforcement Priorities for
> Single-Use Devices Reprocessed by Third Parties and Hospitals:
>
> <http://www.fda.gov/cdrh/reuse/index.shtml>
>
> n\. Product Code Classification Database:
> <http://www.fda.gov/cdrh/prodcode.html>