SAMPLE COMPANY                                        Page 1 of 4
SOP # 04-4  Revision: 0                Prepared by:             _
Effective Date:                        Approved by:             _


Title:         LABELING

Policy:   Products manufactured and distributed by the company
          must be properly labeled according to all applicable
          domestic and international laws and regulations.
          Labeling must included adequate information to describe
          the product, operating instructions, hazard warnings
          and any other information to avoid accidental
          misleading or incomplete identification.

Purpose:  To establish uniform guidelines for the content
          preparation of labels and control of labeling in
          compliance with company policy directives.

Scope:    This procedure applies to all labels and labeling (see
          definitions below) for all products manufactured and
          distributed by the company.  Promotional material and
          operation manuals are covered by other specific SOP
          statements.

Contents:

     Definitions
1.0  Preparation
2.0  Approval and Implementation
3.0  Label Control


Definitions:

     Label - Any display of written, printed or graphic matter
     upon the immediate container of the product.

     Labeling - Includes labels above and other written, printed
     or graphic matter on product containers, wrappings or
     accompanying the product such as tags, pamphlets, direction
     sheets, operation manuals, promotional material or package
     inserts.

     Promotional Material - Advertisements, direct mail pieces,
     brochures, selling aids, films or similar materials or media
     whereby claims concerning safety, efficacy, reliability or
     other product attributes may be made or inferred to the
     customer.

LABELING                                              Page 2 of 4


     Misbranding - A product is misbranded if:

     - its labeling is false or misleading;

     - its packaging does not bear a label containing the name
     and place of business of the manufacturer or distributor and
     an accurate statement of the quantity of contents;

     - words, statements or other required information are not
     prominent on the labeling or are not stated clearly;

     - it does not contain adequate directions for use including
     warnings against use in certain conditions;

     - the product's established name, if it has one, or common
     or usual name is not printed prominently in type at least
     half as large as used for any proprietary name;

     - a medical device is commercially distributed without FDA
     concurrence on a 510(k) premarket notification submission.


Procedures:

1.0  Preparation

1.1  Operating departments such as Engineering, Marketing,
     Manufacturing or Quality Assurance will determine the need
     for a product label or labeling and will forward the request
     to Engineering Services.

1.2  The label contents are to be complete and accurate with all
     necessary information to ensure compliance with all
     applicable requirements.

1.3  All labels must be designed, printed and applied to products
     and containers so that the labels will remain in place and
     legible during the customary conditions of distribution,
     storage and use.  Also, other labeling such as operation
     manuals should remain legible during use and storage by the
     customer.

     Labels may be mounted by adhesives, screws, rivets, drive
     screws, etc., or printed (silk screened) or etched onto
     panels and/or controls.  Labels should be located on the
     product where they will be seen but not abraded during use.
LABELING                                              Page 3 of 4


1.4  The Engineering Department will be responsible for preparing
     a manuscript complete with illustrations or a drawing(s) of
     the label showing the wording, label design and use or
     location for approval.

2.0  Approval and Implementation

2.1  Engineering Services will then forward the labeling
     documentation along with the Approval Form for Labels and
     Labeling (Exhibit 1) to the originating department and
     circulates it through Engineering, Customer Service,
     Marketing and Quality Assurance.

2.2  Engineering Services will coordinate and track all label
     approvals and approval forms.

2.3  Upon approval, the label or manuscript is assigned a drawing
     number and is released and added to the device master record
     file and DMR index.

2.4  When the labels or labeling is produced or printed, Quality
     Control must inspect the material in accordance with
     receiving procedures and proofread the material and verify
     that it is correct and so indicate by signing an appropriate
     document (first article inspection).

2.5  Any changes to labels or labeling are accomplished by
     document change control procedures contained in the
     Engineering Change Notice SOP.

3.0  Label Control

3.1  Labels and labeling materials are to be stored in an area
     and manner suitable to prevent mixups.  Labeling should be
     identified and segregated to the degree necessary to prevent
     mixing of similar labeling.  Access to labeling should be
     limited to authorized personnel.

3.2  Labeling and packaging operation areas should be separated
     to the degree necessary to assure there are no mixups
     between similar products or labels.  Separation may be
     either a physical or spatial separation or by performing the
     labeling and packaging at different times for different
     products.  Separation is not required when mixups are
     impossible such as the case of labeled front panels that can
     only fit the intended product.

     Unused labeling that contains pre-coded serial numbers,
     manufacturing date, expiration date, control number, etc.;
     should be destroyed and not returned to the label storage
     area.