labeling and labeling controls -...

An AAMI Webinar:

Labeling and Labeling Controls

Speakers: Arthur J. Ward, PhD

Christine Nelson

November 16, 2010 11:00 am – 1:00 pm EST

10:00 am – 12:00 pm CST 9:00 am – 11:00 am MST 8:00 am – 10:00 am PST

16:00 – 18:00 GMT

Presented by:

Association for the Advancement of Medical Instrumentation

The Association for the Advancement of Medical Instrumentation (AAMI) has granted permission to the program speakers to quote from standards produced and published by AAMI. Views expressed by the speakers herein do not represent the views of AAMI or any AAMI Standards Committee or U.S. Technical Advisory Group administered by AAMI. Information concerning the content of draft standards that speakers may include within these materials is subject to change as a result of ballot and public review. Therefore, the content of a final standard could differ significantly from the content of its draft version. AAMI is a not-for-profit association whose programs include the development of voluntary consensus standards for medical devices, and educational programs about medical devices for the healthcare community. AAMI does not test or otherwise evaluate specific products or services, endorse specific products or services, or attempt to monitor claims by manufacturers or consumers that certain products or services meet, or do not meet, AAMI standards.

AAMI’s STATEMENT OF QUALITY EDUCATION The Association for the Advancement of Medical Instrumentation (AAMI) strives for the highest possible standards in its educational resources and programs. AAMI endeavors to offer timely, practical, innovative, and visionary educational opportunities so that individuals will be knowledgeable in medical device management, regulation, and standards, equipped with the tools necessary for effective and informed decision making, and recognized as an integral part of healthcare delivery worldwide. GUIDING PRINCIPLES Excellence: AAMI believes that excellence in education is fundamental to safe and effective design, production, and use of medical devices, essential to the pursuit of new innovations, and central to the assurance of positive healthcare outcomes for all individuals. Fair Balance: AAMI maximizes fair balance in its educational programs in order to provide multiple perspectives from which its members can form professional opinions and become valuable resources in the healthcare continuum. Integrity: AAMI seeks to maintain the respect of all healthcare professionals, faculty members, students, and others by constantly improving its educational programs, by providing the best educational services available, and by maintaining a professional and positive learning environment. Value: AAMI strives to make high quality, accessible, and affordable education programs a top priority. Collaboration and Cooperation: AAMI believes that a collaborative learning environment encourages communication among colleagues and contributes to the fulfillment of professional and personal educational goals. To this end, AAMI seeks ways to foster interaction among its members and others by optimizing opportunities for sharing ideas and exchanging valuable information and knowledge. Responsibility: AAMI accepts its responsibility to contribute not only to the on-going learning of the medical device industry and individual healthcare technology managers and operators, but to the enrichment and advancement of the healthcare system. Through a commitment to offering excellent educational programs, it is AAMI’s goal to help its members exceed the expectations of those they serve and to improve patient outcomes. Leadership: By occupying a position of unique leadership in education, AAMI members and all others who participate in its educational programs will meet new challenges with creative solutions, face new questions with in-depth knowledge, and embrace new opportunities with unbridled and open-minded enthusiasm.


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November 16, 2010Presented by

Association for the Advancement of Medical Instrumentation

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Speakers

Arthur J. Ward, PhD - Medical Device Consultant, AJW Technology Consultants Inc.

Christine Nelson - Trainer/Consultant


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Webinar CD

Would you like the ability to refer back to the information presented during today’s webinar at a later date?

Or, do you know of someone who couldn't participate in the webinar but would find the materials presented informative and useful?

CDs of the program will be available for shipment in three weeks. To purchase, please visit http://aami.confedge.com/asset/confEdge/aami/_warehouse/files/CDOrderFormLLCWCD.pdf

$295 for webinar registrants $395 for non-registrants

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Handouts

To download the slides presented during the webinar, please go to: http://aami.confedge.com/ap/eSite/?i=Labeling


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Audience Composition

We will now poll the audience to determine how many people are joining us today. Please enter the number of people at your site in the text box on your screen.

Labeling Controls

Training Program

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Labeling Objectives

Review key definitionsProvide an overview of labeling regulations

21 CFR 80121 CFR 82021 CFR 809

Review key labeling controlsSelected review of labeling guidance

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Definitions – From Food, Drug, & Cosmetic Act

Labels – a display of written, printed or graphic matter upon the immediate container of an article


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Definition

Labeling – all labels and other written, printed or graphic materials

On an article or its containers or wrappersAccompanying such article at any time….

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Labeling Applies to…

Labels on productsLabeling accompanying products

InsertsUser manualService manualPatient guides


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Labeling Applies to…

Labeling about productsBrochures LiteratureWeb siteExhibition materialOral communication

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Labeling Regulations

21 CFR 80121 CFR 809 (In Vitro Diagnostics)21 CFR 820


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Labeling Regulations

21 CFR 801

Labeling for Medical Devices

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Primary Requirements

21 CFR 801.1Label must display

Manufacturer’s nameCity and stateFull address if not listed in city directory


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21 CFR 801.1If the device is not manufactured by firm then include statements like

Manufactured for, orDistributed by

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21 CFR 801.4Intended use is shown by

Labeling claimsAdvertisingWritten or oral statements by firm or their representatives


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21 CFR 801.5Directions for use must be adequate for the layman using device (which may be a medical professional) and include:

Normal dosageFrequency of administrationDuration of applicationTime of administration in relation to symptomsMethod of administrationPreparation for useTemperature or other adjustment

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21 CFR 801.15All required statements must be sufficient in size and space to be properly conspicuousLabel space allocated must be adequate to fit all required information


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21 CFR 801.60Over-the-counter labeling

Provides for numerous principal panel display requirements depending on the shape of the package (e.g., cylindrical or rectangular)

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21 CFR 801.109-.150Labeling exemptions

For particular reasons citedFor commonly known devicesFor IVD devices if they comply with 21 CFR 809.10


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21 CFR 801.405-.437Special labeling requirements

Hearing aidsTamponsCondomsNatural rubber productsDentures

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21 CFR 809

In Vitro Diagnostic Products for Human Use


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Primary Requirements –In Vitro Diagnostics

21 CFR 809.10 – a specific regulation for labeling of IVD productsSpecial sections for both instruments and reagents

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Some of the requirements for reagents include:

Established or common nameNet quantity in volumes or weight, etc.Quantity or concentration of reactive ingredientMeans for user to be assured of its purity or quality at time of use


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Statement of intended useManufacturer’s name and addressLot number or control numberExpiration dateStorage instructions

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Statements of user warning and precautions per 16 CFR 1500A statement: “For In Vitro Diagnostic Use”Any reconstitution instructions needed


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Additional requirements for instruments include:

Serial or control number that will permit tracing to identify all function assembliesFor multiple-unit products that must be used together as a system, a way to link all of the suitable identification information

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Some of the requirements for reagent packaging inserts include:

Proprietary name and common nameIntended use and type of procedureSummary and explanation of the testChemical, physical or biological principles of the procedure


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Warnings and precautionsInstructions for reconstitution, mixing, etc.Storage instructionsAny purification or treatment needed before use

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Physical, biological or chemical indications of instability or deteriorationA statement: “For In Vitro Diagnostic Use”


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Some of the requirements for instrument packaging inserts or manuals include:

Statement of use or functionInstallation proceduresOperating principlesPerformance characteristics and specifications

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Some of the requirements for instrument packaging inserts include:

Operating instructionsCalibration proceduresHazards and operational precautionsService and maintenance informationSpecimen collection and preparation


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Precautions for specimen collection and need for additives, etc.Information on known interfering substancesSpecimen storage and handling instructionsA step-by-step procedure outline

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A list of materials provided and those also neededThe amount of reagent necessary with detailed information on its useStatement of the stability of the final reaction


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Instrument calibration detailsQuality control procedures and use of negative and positive controlsMethod for calculating the unknown resultLimitations and expected values

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Specific performance characteristicsBibliography for referenceManufacturer’s name and locationDate of issuance of the last labeling revision


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21 CFR 820

Quality System Regulation

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21 CFR 820.3jDevice Master Record definition:

Compilation of records containing procedures and specifications for a finished device


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21 CFR 820.181Device Master Record

Includes all labels in the device or its packagingIncludes all labeling “accompanying” device (whether electronic or printed)

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21 CFR 820.120 – Device LabelingIntegrityInspectionStorageOperations


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21 CFR 820.120aLabeling controls - integrity

LegibilityRemain affixed

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21 CFR 820.120bLabeling controls - inspection

Performed before storage or use by a designated individualDocumented including release date and signature


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21 CFR 820.120bLabeling inspection

Includes – label accuracyCorrect expiration dateControl number Special storage instructionsHandling instructionsAdditional processing instructions

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21 CFR 820.120cLabeling controls - storage

All labels stored • Properly identified• Prevent mix ups


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21 CFR 820.120dLabeling controls - operations

Control labeling to prevent mix-ups (line clearance is a method)Labels and labeling used must be recorded in DHR

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21 CFR 820.120eLabel control number

When device requires a control number or you assign one, the control number must be legible and accompany device through distribution


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21 CFR 820.3(g) – Design OutputProduct specifications are the design outputDesign output consists of

A device LabelingPackaging Device master record

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21 CFR 820.3iDevice History Record – definition

Compilation of records containing production history for a finished device


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21 CFR 820.184Device History Record must include

Date manufacturedQuantity manufactured and quantity releasedAcceptance records showing device made per DMRPrimary identification labelOther labeling used for each deviceDevice identification and control number

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Labeling Practices

Assign each label/labeling item a distinct part numberHave approved labeling masters by revisionControl any changes via formal ECO process


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Labeling Practices

Purchased labelingQualify supplier on approved vendor listApproved specification sent to supplierUse purchase order processIncoming inspectionInspection recordsStorage and warehouse controls

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Labeling Practices

Internal printed labelingUse approved specificationEquipment qualificationSoftware validationProcess validation (if applicable)Formal inspection that is documented


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Labeling Practices

Labeling issued by work orderLabels counted when issuedFormal line clearance between production lots or work ordersOnce a lot is completed account for unused labels

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Labeling Practices

Device History Record – by lotAttach primary identification label/copyRecord all other labeling in DHRIf batch includes multiple serial numbers

Copy first and last or write in serial number range


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Guidance Information

FDA has issued a number of Labeling Guidances, and these are just a select few to review

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E-Labeling

FDA Guidance dated March 31, 2003Blue Book Memorandum # G03-1

Permits e-labeling for all professional productsHard copy of all labeling must be made available on requestE-labeling is not permitted for non-professional products, i.e., home use


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E-Labeling

A link to the FDA E-Labeling Guidance may be found at:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109200

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Symbols for IVD Labeling

FDA Guidance dated November 30, 2004FDA recognized a series of symbols that may be used on IVD productsThe Guidance provides a copy of each of the allowed symbols and their definition


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Symbols for IVD Labeling

A link to the FDA IVD Symbol Labeling Guidance may be found at:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085404.htm

Other than this Guidance there is currently minimal recognition of symbols by FDA

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Adding URLs to Electronic Products

FDA Guidance dated September 30, 2010FDA is encouraging the addition of Uniform Resource Locators on all electronic productsAlso the inclusion of the firm’s

Full nameAddressMonth and year of product manufacture


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Adding URLs to Electronic Products

A link to the FDA URL Labeling Guidance may be found at:http://www.fda.gov/MedicalDevices/DeviceR

egulationandGuidance/GuidanceDocuments/ucm228553.htm

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Labeling Summary

Prepared per the applicable regulation(s) and GuidanceSpecified in DMRInspectedControlledDocumented in DHR


To submit a question, please type your question in the “Chat (Q&A)” box on the left side of your screen and press Enter, or press *1 on your telephone keypad.

Questions?

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Closing Reminders

• Please be sure to fill out the evaluation form after the webinar. If you have additional comments, please contact Emilee Hughes at (703) 253-8278 or [email protected].

• CDs of this program will be available for shipment in three weeks. To purchase, please visit http://aami.confedge.com/asset/confEdge/aami/_warehouse/files/CDOrderFormLLCWCD.pdf.• $295 for webinar registrants • $395 for non-registrants

• Visit http://www.aami.org/meetings/webinars/ to learn about AAMI’s future webinar events. Upcoming programs include:• ANSI/AAMI ST79 Steam Sterilization Update• Joint Commission Activities Impacting Biomedical and Clinical Engineering

Departments • AAMI/IEC 80001-1 - Risk Management for IT Networks

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