'Special labeling requirements' presentation slideshows

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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