Hello, JNPMEDI has prepared medical device clinical trial plan approved in February 2025.
Shall we take a closer look? ๐
In February, medical devices for various indications such as panic disorder, Alzheimer's disease, ADHD, autism spectrum disorder, as well as software devices for purposes like predicting hypotension, treating aphasia, and evaluating neurogenic bladder, were approved by the Ministry of Food and Drug Safety.
These clinical trials reflect the growing interest in digital therapeutics.
This month, we will be looking into clinical trials for digital therapeutic devices aimed at treating panic disorder.
Digital therapeutic devices for panic disorder are based on cognitive behavioral therapy and are designed to improve symptoms without requiring hospital visits, through mobile apps or websites. Currently, several institutions are conducting studies to verify the efficacy and safety of this treatment method.
Accordingly, the Ministry of Food and Drug Safety (MFDS) issued the "Guideline for Safety, Performance Evaluation, and Clinical Trial Protocol Writing for Digital Therapeutic Devices for Panic Disorder" in December 2022, outlining the classification of related medical devices and clinical trial design standards. Digital therapeutic devices for panic disorder are classified as emotional disorder treatment software (Class 2, E06070.01) and, when aimed at evaluating or treating co-occurring psychiatric symptoms, may also be registered as combination medical devices, incorporating psychological evaluation software (E06050.01) or cognitive treatment software (E06060.02).
According to the guidelines, the primary inclusion criteria are 1) individuals diagnosed with panic disorder according to DSM-5 or ICD-10, and 2) individuals with a Panic Disorder Severity Scale (PDSS) score of 6 or higher. PDSS is provided as an example of the primary efficacy assessment variable. A sham device is recommended as the control group, though a wait-list control group can also be applied depending on the study design. The recommended duration for the clinical trial is between 6 to 12 weeks (with at least 3 visits), depending on the device characteristics.
Meanwhile, starting January 24, 2025, the ใDigital Medical Products Actใ will be enacted, and emotional disorder treatment software will be recognized as digital medical device software under this law. Consequently, to receive approval for clinical trials of digital therapeutic devices for panic disorder, manufacturers must meet essential requirements, including selecting a product code under the Digital Medical Products Act and preparing to meet additional regulatory demands.
The development of digital therapeutic devices is expected to improve access to treatment for various disorders, including panic disorder, and enhance patient treatment adherence. If further research demonstrates the effectiveness of these devices, they will likely be widely used for treating other mental health conditions such as depression and anxiety disorders.
We will be back with more valuable information on clinical trials.
Thank you ๐
๐ References
- https://emedi.mfds.go.kr/portalย
- https://alllivec.co.kr/project/detail/1376
Hello, JNPMEDI has prepared medical device clinical trial plan approved in February 2025.
Shall we take a closer look? ๐
In February, medical devices for various indications such as panic disorder, Alzheimer's disease, ADHD, autism spectrum disorder, as well as software devices for purposes like predicting hypotension, treating aphasia, and evaluating neurogenic bladder, were approved by the Ministry of Food and Drug Safety.
These clinical trials reflect the growing interest in digital therapeutics.
This month, we will be looking into clinical trials for digital therapeutic devices aimed at treating panic disorder.
Digital therapeutic devices for panic disorder are based on cognitive behavioral therapy and are designed to improve symptoms without requiring hospital visits, through mobile apps or websites. Currently, several institutions are conducting studies to verify the efficacy and safety of this treatment method.
Accordingly, the Ministry of Food and Drug Safety (MFDS) issued the "Guideline for Safety, Performance Evaluation, and Clinical Trial Protocol Writing for Digital Therapeutic Devices for Panic Disorder" in December 2022, outlining the classification of related medical devices and clinical trial design standards. Digital therapeutic devices for panic disorder are classified as emotional disorder treatment software (Class 2, E06070.01) and, when aimed at evaluating or treating co-occurring psychiatric symptoms, may also be registered as combination medical devices, incorporating psychological evaluation software (E06050.01) or cognitive treatment software (E06060.02).
According to the guidelines, the primary inclusion criteria are 1) individuals diagnosed with panic disorder according to DSM-5 or ICD-10, and 2) individuals with a Panic Disorder Severity Scale (PDSS) score of 6 or higher. PDSS is provided as an example of the primary efficacy assessment variable. A sham device is recommended as the control group, though a wait-list control group can also be applied depending on the study design. The recommended duration for the clinical trial is between 6 to 12 weeks (with at least 3 visits), depending on the device characteristics.
Meanwhile, starting January 24, 2025, the ใDigital Medical Products Actใ will be enacted, and emotional disorder treatment software will be recognized as digital medical device software under this law. Consequently, to receive approval for clinical trials of digital therapeutic devices for panic disorder, manufacturers must meet essential requirements, including selecting a product code under the Digital Medical Products Act and preparing to meet additional regulatory demands.
The development of digital therapeutic devices is expected to improve access to treatment for various disorders, including panic disorder, and enhance patient treatment adherence. If further research demonstrates the effectiveness of these devices, they will likely be widely used for treating other mental health conditions such as depression and anxiety disorders.
We will be back with more valuable information on clinical trials.
Thank you ๐
๐ References