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This document summarizes the safety and effectiveness data for the Restylane Injectable Gel, an injectable dermal filler used for mid-to-deep dermal implantation for the correction of facial wrinkles
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How to fill out summary of safety and
How to fill out Summary of Safety and Effectiveness Data
01
Start with the device name and its intended use.
02
Provide a comprehensive description of the device, including its design and technological characteristics.
03
Summarize the non-clinical testing results, including any performance data.
04
Present clinical study information, including study design, population, and results.
05
Discuss any adverse events or side effects observed during clinical studies.
06
Compare the device's safety and effectiveness to that of the predicate device if applicable.
07
Conclude with a summary statement on the overall safety and effectiveness of the device.
Who needs Summary of Safety and Effectiveness Data?
01
Regulatory agencies evaluating new medical devices.
02
Manufacturers seeking approval for their medical devices.
03
Healthcare providers assessing the safety and efficacy of devices.
04
Patients seeking information about medical devices.
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People Also Ask about
What is the integrated summary of safety?
Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) are Regulatory submission documents which are required to be submitted to the Food and Drugs Administration (FDA) while filing a New Drug Application (NDA).
What is safety and effectiveness?
EFFICACY AND SAFETY. Efficacy and safety are separate concepts; they can be measured and discussed as. distinct properties of a medical technology. Efficacy is defined in terms of a benefit; safe- ty, in terms of a risk.
What is the ISS statistical analysis plan?
Integrated Statistical Analysis Plan This plan describes how data from different studies will be pooled and analyzed collectively. It specifies the programming and output for the Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE), which are pivotal for regulatory submissions.
What is the ISS in medical writing?
What is an ISS and an ISE? The integrated summary of safety (ISS) and integrated summary of effectiveness (ISE) are critical documents required for regulatory submissions in the approval of new medicines/drugs or devices.
What does ISS stand for in pharma?
Integrated Summary of Safety (ISS) An overall analysis and summary of the safety data required by the FDA for an NDA or BLA.
What is the medical definition of ISS?
The Injury Severity Score (ISS) is an established medical score to assess trauma severity. It correlates with mortality, morbidity and hospitalization time after trauma.
What is ISS in clinical research?
Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) are Regulatory submission documents which are required to be submitted to the Food and Drugs Administration (FDA) while filing a New Drug Application (NDA).
What is the ISS statistical analysis plan?
Integrated Statistical Analysis Plan This plan describes how data from different studies will be pooled and analyzed collectively. It specifies the programming and output for the Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE), which are pivotal for regulatory submissions.
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What is Summary of Safety and Effectiveness Data?
The Summary of Safety and Effectiveness Data is a document that provides a comprehensive overview of the safety and effectiveness of a specific medical device or healthcare product as evaluated through clinical studies and regulatory assessments.
Who is required to file Summary of Safety and Effectiveness Data?
Manufacturers of medical devices or healthcare products that seek approval or clearance from regulatory authorities, such as the FDA, are required to file a Summary of Safety and Effectiveness Data.
How to fill out Summary of Safety and Effectiveness Data?
To fill out the Summary of Safety and Effectiveness Data, manufacturers should follow the regulatory guidelines provided by the respective authorities, ensuring that they include relevant data from clinical trials, risk assessments, and all necessary supporting documentation.
What is the purpose of Summary of Safety and Effectiveness Data?
The purpose of the Summary of Safety and Effectiveness Data is to inform regulatory bodies, healthcare providers, and the public about the safety and effectiveness of a medical product, facilitating informed decision-making and ensuring public health protection.
What information must be reported on Summary of Safety and Effectiveness Data?
Information that must be reported includes the results of clinical studies, adverse event data, risk management information, comparisons with similar products, and any conclusions regarding the device's safety and effectiveness.
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