Characteristics and use of patient-reported outcomes of clinical trials for high-risk neurological medical devices that received FDA premarket approval from 2001 to 2022

Author:

Ryan Morgan E.,Srivastava Siddharth,Wan Lin,Yang Guang,Zhang Bo

Funder

U.S. Food and Drug Administration

Publisher

Elsevier BV

Subject

Pharmacology,General Medicine

Reference12 articles.

1. FDA-approved neurologic devices intended for use in infants, children, and adolescents;Peña;Neurology,2004

2. Assessment of US Food and Drug administration–approved digital medical devices for just-in-time interventions: a systematic review;Phi;JAMA Intern. Med.,2023

3. Regulation of neurological devices and neurointerventional endovascular approaches for acute ischemic stroke;Loftus;Front. Neurol.,2018

4. Food and Drug Administration. Summary of Safety and Effectiveness Data: Vercise™ Deep Brain Stimulation (DBS) System (P150031B). https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150031B.pdf.pdf. Accessed June 2, 2022.

5. Food and Drug Administration. Summary of Safety and Effectiveness Data: Saluda Medical Evoke® SCS System (P190002B). https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190002B.pdf. Accessed June 2, 2022.

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