Federal Register #FDA2026N5828

FDA Classifies SMA Newborn Screening Test System as Class II Medical Device

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued a final order regarding the classification of a medical device for newborn screening: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - PerkinElmer Inc. (submitted De Novo classification request) - Products/Services Requested: - Spinal Muscular Atrophy (SMA) newborn screening test system - Detects homozygous deletion of exon 7 or similar mutations in the SMN1 gene - Utilizes polymerase chain reaction (PCR) from dried blood spot specimens - Example product: Eonis SCIDSMA Kit (PerkinElmer Inc.) - Unique or Notable Requirements: - Device classified as Class II with special controls under 21 CFR Part 866 - Special controls include requirements for device design, validation, labeling, and performance studies - Intended to provide reasonable assurance of safety and effectiveness - Aims to reduce regulatory burdens and enhance patient access - No procurement solicitation, purchase quantities, or part numbers are specified - Notice is not a request for bids or proposals, nor an award announcement

Description

The Food and Drug Administration (FDA) is classifying the Spinal Muscular Atrophy newborn screening test system into class II (special controls). This device is a prescription device intended to detect homozygous deletion of exon 7 or similar mutations in the SMN1 gene from dried blood spot specimens using a polymerase chain reaction-based test as an aid in screening newborns for SMA. The classification aims to provide reasonable assurance of safety and effectiveness and reduce regulatory burdens to enhance patient access to beneficial devices. The order is effective June 11, 2026, with classification applicable from November 9, 2022.

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