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Classification of HLA Devices FDA Recommendations & Questions

Classification of HLA Devices FDA Recommendations & Questions. Sheryl A. Kochman CBER/OBRR/DBA. Where Do HLA Devices Fit?. Current CBER review incorporates special controls performance standards, e.g. 80% concordance special labeling requirements recommendations Device is moderate-risk

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Classification of HLA Devices FDA Recommendations & Questions

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  1. Classification of HLA DevicesFDA Recommendations & Questions Sheryl A. Kochman CBER/OBRR/DBA

  2. Where Do HLA Devices Fit? • Current CBER review incorporates special controls • performance standards, e.g. 80% concordance • special labeling requirements • recommendations • Device is moderate-risk • NOT life-supporting, life-sustaining, or of substantial importance in preventing impairment of human health and does not present a potential unreasonable risk of illness or injury

  3. How Does FDA Propose to Regulate HLA Devices in the Future? • Continue to require submission of a 510(k) • Continue to require special labeling • Continue to review against performance standards • Continue to apply recommendations • Prepare and implement a guidance document • Make HLA devices eligible for Third Party Review • Identify and accredit third party reviewers

  4. FDA Recommendation • HLA devices, as defined earlier, should be placed in Class II

  5. Question to the Committee • Does the Committee agree that HLA devices (for use in detecting antibodies to HLA antigens or determining HLA phenotype or genotype) should be classified as Class II devices? • Should they be exempt from the requirement to submit a 510(k)?

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