Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
2019-576 CDRH Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder Draft Guidance for Industry and Food and Drug Administration Staff Availability OPEN
2023-10-18 2023-10-18 2023-10-18 2023-10-24 2023-10-18
FDA-2023-D-0466-0011 FDA-2023-D-0466-0004 FDA-2023-D-0466-0010 FDA-2023-D-0466-0015 FDA-2023-D-0466-0003
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https://api.regulations.gov/v4/comments/FDA-2023-D-0466-0011 https://api.regulations.gov/v4/comments/FDA-2023-D-0466-0004 https://api.regulations.gov/v4/comments/FDA-2023-D-0466-0010 https://api.regulations.gov/v4/comments/FDA-2023-D-0466-0015 https://api.regulations.gov/v4/comments/FDA-2023-D-0466-0003
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Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder The FDA has been actively addressing the opioid overdose crisis by taking measures to reduce unnecessary opioid exposure and support OUD treatment so im going to comment related deficiency  the things which not include in scope of this guidance.1.The CDRH is committed to contributing to the efforts to combat this national crisis and offers recommendations to ensure the safety and effectiveness of devices intended to treat OUD in the clinical study design process.2.Some products such as, diagnostic tests for opioid use and devices intended for pain treatment are not falling in this guidance.3.By which pathway Devices Intended to Treat Opioid Use Disorder should be approved is not given.4.Guidance should also report what kind subjects used for clinical study additional provide the information about clinical study plan for devices intended to treat Opioid Use Disorder OSD. Comment on Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder Non-pharmacological preventative measures to address OUDDetermining cost savings in preventing OUD vs. treating after the fact such as opioid clinics and treatment centers. Determine percentage of patients with unintended OUD at onset of first prescription Determine the financial, battle readiness and phycological impact of OUD in active-duty military and veterans. Ensure any approach is an interdepartmental, interagency process that combined allows a potential solution to move forward unabated allowing it to arrive at a scientific determination of effectiveness. Explore FDA cleared/FDA approved Class II and Class III technologies already in place to provide a non-pharmacological solution to preventing opioid addiction. Protocols applied to known technologies, the evidence shows a lower first dose and subsequent reduction of dosages preventing the need to prescribe a second dose. This suggestion based on direct experience presenting this Opioid Preventive solution to HHS in October 2016 by invitation of Secretary Tom Price. Design a preventative treatment flowchart showing Opioid Preventative oDrug Manufactured and available by prescriptionoPrescribers such as Hospitals, Private Practice, Active Military and VAoPatient who has a injury or diagnosed with acute, subacute or chronic pain. Include post-surgery therapy and treatment of pain. oInsert technology and protocols that demonstrate technologys ability to mitigate the patient issue with pain the number on objective to no more than 30 days oIncludes treatment protocol, treatment frequency, treatment time over a 2-week to 4-week period. Achieved preventing a need to re-prescribe. Protocol that patient feedback adds to measure effectiveness of treatment.oPost treatment assessment showing patient adherence to protocol schedule, initial opioid dosage, reduced dosage over treatment period and overall patient outcome. Estimate impact on US population with an effective preventive solution in place. Some of the areas of focus might be:Reduced costs in managing addition, overdose and suicideMilitary battle readiness and reduction of VA costsLess liability for the physicianLess burden on HHS and its departmentsA Model of leadership that may be followed across the globeAnd the individual quality of life due to preventing vs. treatingSuggest primary focus on prevention readily available, science based and backed by clinical studies, while maintaining the treatment of addiction until the scales of prevention and treatment balance equally until prevention becomes primary and addiction treatment secondary.  The FDA has been actively addressing the opioid overdose crisis by taking measures to reduce unnecessary opioid exposure and support OUD treatment so im going to comment related deficiency  the things which not include in scope of this guidance.1.The CDRH is committed to contributing to the efforts to combat this national crisis and offers recommendations to ensure the safety and effectiveness of devices intended to treat OUD in the clinical study design process.2.Some products such as, diagnostic tests for opioid use and devices intended for pain treatment are not falling in this guidance.3.By which pathway Devices Intended to Treat Opioid Use Disorder should be approved is not given.4.Guidance should also report what kind subjects used for clinical study additional provide the information about clinical study plan for devices intended to treat Opioid Use Disorder OSD.