FDA Greenlights Shin-Zap Implant for Bladder Control Shenanigans
Published Date: 9/10/2026
Rule
Summary
The Food and Drug Administration (FDA) is classifying the implanted tibial electrical urinary continence device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the implanted tibial electrical urinary continence device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 0 costs, 1 mixed.
Class II Rule May Improve Patient Access
The FDA has classified the implanted tibial electrical urinary continence device as Class II (special controls). This classification is effective September 10, 2026 and was made applicable August 16, 2023; FDA says this will enhance patients' access to the device by reducing regulatory burdens and providing reasonable assurance of safety and effectiveness.
Easier Market Pathway for Device Makers
Because FDA used the De Novo process, this implanted tibial electrical urinary continence device can serve as a predicate for future devices so other sponsors can use the less-burdensome 510(k) process rather than a premarket approval application. That change reduces regulatory burden for device sponsors and may speed new competing products to market.
Safety Tests, Labeling, and Contraindications Set
The final order requires special controls such as electrical, thermal, electromagnetic compatibility, sterility and shelf-life testing, software verification/validation, and magnetic resonance compatibility testing. The device must be prescription-only and labeling must include a contraindication against use during pregnancy and a contraindication for men who have benign prostatic hyperplasia (BPH), plus specific patient instructions (post‑operative care, avoiding overstimulation, avoiding interference with other medical devices) and shelf-life information.
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Key Dates
Department and Agencies
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