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BioWorld - Wednesday, July 6, 2022
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Home » FDA retains 12-month follow-up mandate in BPH final guidance
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FDA retains 12-month follow-up mandate in BPH final guidance

Dec. 28, 2021
By Mark McCarty
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The FDA has delivered on a final guidance for non-clinical and clinical investigations of devices used for treatment of benign prostatic hyperplasia (BPH), needing only a year and a half to convert the draft guidance into a final version. The final guidance retains the draft’s recommendation that pivotal studies follow patients for at least a year, a provision some in the med-tech industry saw as unnecessary in some instances. The scope of the July 2020 draft included non-clinical testing, a novelty compared to previous guidance on the topic. The scope of this latest guidance includes four product codes, including KNS for endoscopic electrosurgical instruments, and the FDA included several specific suggestions for the use of thermotherapy and permanent prostatic stents as treatments for BPH.
BioWorld MedTech Regulatory Genitourinary/Sexual Function U.S. FDA

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