EUROLAB
fda-guidance-for-dermatological-testing-of-topical-products
Dermatological & Sensitivity Testing AFNOR BP X30-221 In Vivo Human Skin Testing ProceduresASTM D2979 Assessment of Skin Sensitization PotentialASTM D4236 Labeling of Cosmetic Products for Skin SafetyASTM D6125 Evaluation of Skin Sensitization Using In Vitro ModelsASTM D6977 Evaluation of Skin Contact AllergensASTM E1490 Evaluation of Allergic Contact DermatitisASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended ProtocolASTM E2753 Human Repeat Insult Patch Test (HRIPT)ASTM F2312 Evaluation of Patch Test Allergen ReleaseCOLIPA Guidelines for Skin Compatibility TestingEN 16820 Test Method for Skin Sensitization PotentialEN 1811 Determination of Nickel Release from Skin-Contact ProductsEN ISO 10993-10 Assessment of Skin IrritationEN ISO 10993-18 Chemical Characterization for Dermal SafetyEN ISO 10993-21 Evaluation of Skin Irritation from Medical Device ExtractsEN ISO 10993-5 Cytotoxicity Testing on Skin CellsEP 5.1.6 Evaluation of Dermatological Safety of CosmeticsFDA 21 CFR 820 Quality System Regulation for Dermal DevicesFDA 21 CFR Part 807 Sensitivity Testing of Topical ProductsFDA Guidance on Dermal Sensitization Risk AssessmentISO 105-A02 Colorfastness to Artificial Light on SkinISO 10993-1 Biological Evaluation of Medical Devices - Dermal AspectsISO 10993-10 Evaluation of Skin Irritation and SensitizationISO 10993-11 Toxicity Testing Related to Skin ContactISO 10993-12 Sample Preparation for Dermal TestingISO 10993-16 Toxicokinetic Testing of Substances in Dermal ExposureISO 10993-17 Toxicological Risk Assessment for Dermal ProductsISO 10993-19 Evaluation of Allergic Contact Dermatitis in Skin ProductsISO 10993-20 Dermal Toxicology Testing MethodsISO 10993-22 Evaluation of Sensitization from Skin Contact DevicesISO 10993-23 Evaluation of Phototoxicity and PhotoallergyISO 11137 Sterilization Validation of Dermal DevicesISO 11930 Preservative Effectiveness for Sensitive Skin ProductsISO 14155 Clinical Investigation of Medical Devices on SkinISO 15223-1 Symbols for Dermal Medical DevicesISO 15223-1 Symbols for Indicating Skin Contact in Medical DevicesISO 16128 Guidelines on Natural and Organic Cosmetic IngredientsISO 16128-1 Guidelines on Natural and Organic Cosmetics Part 1ISO 16128-2 Calculation of Natural Ingredient Content in Skin ProductsISO 16128-3 Methodologies for Determining Organic Content in Skin CareISO 16134 Human Repeat Insult Patch Test GuidanceISO 16134-2 Guidance for Patch Test Interpretation in Skin TestingISO 17516 Microbiological Limits for Skin ProductsISO 21404 Testing for Skin Contact AllergensISO 21486 Risk Assessment for Skin Contact MaterialsISO 22444 Measurement of Skin Moisture ContentISO 22715 Labeling Requirements for Skin and Cosmetic ProductsISO 22716 Good Manufacturing Practices for Dermatological ProductsISO 22716-1 Good Manufacturing Practices for Skin Care ProductsISO 23975 Patch Test Protocols for Dermatological ProductsISO 24441 In Vitro Determination of Sun Protection Factor (SPF)ISO 24442 Evaluation of Human Skin Irritation PotentialISO 24443 In Vitro Assessment of Sunscreen Efficacy on SkinISO 24443 In Vitro SPF Testing for SunscreensISO 24443 In Vitro UV Protection Factor Testing for SunscreensISO 24443 UV Protection Testing for Sensitive Skin FormulationsISO 3160-2 Compression Testing on Skin Contact MaterialsISO 3175-4 Analysis of Volatile Components Affecting Skin SensitivityISO 8124-6 Safety Requirements for Toys Affecting SkinISO/TR 16181 Guidelines on Skin Compatibility of CosmeticsISO/TR 16271 Guidelines on Safety Assessment for Skin Contact MaterialsISO/TR 19218 Dermatological Safety Data ManagementISO/TR 19930 Development of Dermal Sensitization AssaysISO/TR 22219 Testing of Skin Barrier FunctionISO/TR 29622 Allergens in Cosmetics and Personal Care ProductsJIS K 5600-5-7 Patch Test Methods for Skin SensitivityOECD TG 405 Acute Dermal Irritation/Corrosion TestOECD TG 406 Skin Sensitization in AnimalsOECD TG 406 Skin Sensitization Testing in AnimalsOECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin SafetyOECD TG 439 In Vitro Skin Irritation Testing for CosmeticsOECD TG 442B Local Lymph Node Assay for Skin SensitizationOECD TG 442C In Chemico Skin Sensitization Assay (DPRA)OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens™)OECD TG 442E Human Cell Line Activation Test (h-CLAT) for Skin SensitizationOECD TG 442E In Vitro Skin Sensitization Assay (h-CLAT)USP <151> Evaluation of Skin Irritation for Topical Dosage FormsUSP <151> Skin Sensitization Studies in Pharmaceuticals

FDA Guidance for Dermatological Testing of Topical Products: Eurolabs Laboratory Testing Services

The FDA Guidance for Dermatological Testing of Topical Products is a comprehensive set of regulations that govern the testing and evaluation of topical products intended for human use. This guidance document provides detailed information on the testing requirements, methods, and standards to ensure the safety and efficacy of these products.

Relevant Standards

The following international and national standards apply to FDA Guidance for Dermatological Testing of Topical Products:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

  • ASTM E2785-14 Standard Practice for Evaluating the Stability of Cosmetic Ingredients in Personal Care Products

  • EN 71:2016 Safety of Toys (mechanical, physical, and chemical requirements)

  • TSE 1009:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

    • These standards provide a framework for evaluating the safety and efficacy of topical products, including their chemical composition, stability, and potential biological effects on human skin.

    Standard Development Organizations

    The following standard development organizations play a crucial role in developing and maintaining these standards:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Electrotechnical Standardization (CENELEC)

    • These organizations work together to develop and maintain international standards that ensure consistency and comparability across borders.

    Standard Evolution and Updates

    Standards evolve over time as new technologies, research findings, and regulatory requirements emerge. The standard development process involves a collaborative effort between industry stakeholders, researchers, and regulators to update and refine existing standards.

    Standard Numbers and Scope

    The following are specific standard numbers and their scope:

  • ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

    • Covers biological evaluation methods for medical devices, including topical products.

  • ASTM E2785-14 Standard Practice for Evaluating the Stability of Cosmetic Ingredients in Personal Care Products

    • Provides guidelines for evaluating the stability of cosmetic ingredients in personal care products.

    Standard Compliance Requirements

    Compliance with these standards is mandatory for industries that produce and market topical products. Failure to comply can result in regulatory actions, product recalls, and damage to a companys reputation.

    The following are additional standard-related information:

  • GMP (Good Manufacturing Practice) Regulations: These regulations ensure that manufacturers follow guidelines for producing safe and effective products.

  • Risk Management Process: This process involves identifying potential risks associated with product use, evaluating their likelihood and impact, and implementing controls to mitigate them.

    • The following are additional standard-related information:

  • Regulatory Framework: The FDA Guidance for Dermatological Testing of Topical Products provides a comprehensive regulatory framework for testing and evaluation.

  • Industry-Specific Standards: Different industries have specific standards that apply to their products, such as the cosmetics industrys requirements for skin safety.

    • The following are additional standard-related information:

  • Compliance with Regulations: Compliance with regulations is essential for companies operating in regulated industries.

  • Audit and Certification: Companies must undergo regular audits and certifications to ensure compliance with standards and regulations.

    • This section provides an in-depth explanation of the standard requirements and needs for FDA Guidance for Dermatological Testing of Topical Products:

    Why This Test is Needed and Required

    The testing of topical products is essential to ensure their safety and efficacy. Regulatory agencies require companies to conduct these tests as part of their quality control process.

    Business and Technical Reasons for Conducting the Test

    Companies must conduct these tests to:

  • Ensure product safety

  • Comply with regulatory requirements

  • Meet industry standards

  • Protect consumers from potential harm

    • Consequences of Not Performing the Test

    Failure to perform the test can result in:

  • Regulatory actions

  • Product recalls

  • Damage to a companys reputation

  • Financial losses

    • Industries and Sectors that Require This Testing

    The following industries require this testing:

  • Cosmetics industry

  • Pharmaceutical industry

  • Medical device industry

  • Biotechnology industry

    • Risk Factors and Safety Implications

    Potential risk factors include:

  • Skin irritation

  • Allergic reactions

  • Photosensitivity

  • Toxicity

    • Quality Assurance and Quality Control Aspects

    This test is an essential part of a companys quality assurance and quality control process. It ensures that products are safe for consumers and compliant with regulations.

    Contribution to Product Safety and Reliability

    The testing of topical products contributes significantly to product safety and reliability by:

  • Identifying potential risks

  • Evaluating the efficacy of products

  • Ensuring compliance with regulations

    • The following are additional standard requirements and needs:

  • Regulatory Compliance: Companies must comply with regulatory requirements, including testing and evaluation.

  • Industry Standards: Companies must meet industry standards for product safety and efficacy.

    • The following are additional standard requirements and needs:

  • Risk Management Process: This process involves identifying potential risks associated with product use, evaluating their likelihood and impact, and implementing controls to mitigate them.

  • GMP Regulations: These regulations ensure that manufacturers follow guidelines for producing safe and effective products.

    • The following are additional standard requirements and needs:

  • Audit and Certification: Companies must undergo regular audits and certifications to ensure compliance with standards and regulations.

  • Compliance with Standards: Companies must comply with industry-specific standards, including those related to product safety and efficacy.

    • Please let me know if you want me to continue with the rest of the sections.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers