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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K073039 B. Purpose for Submission: Traditional, original 510(k) submission C. Measured: Sperm concentration

How to fill out decision summary - accessdata

How to fill out a decision summary:

1. Identify the purpose of the decision summary: Before starting to fill out the decision summary, it is important to understand the purpose behind it. Is it for personal reference, team collaboration, or reporting to higher management? Clarifying the purpose will help guide the content and format of the summary.
2. Provide an overview of the decision: Begin by briefly describing the decision that was made or needs to be made. This can include any relevant background information, problem statements, or goals associated with the decision.
3. Present the options considered: List the various options that were considered during the decision-making process. It is essential to include both viable and rejected options, highlighting the reasoning and criteria for their inclusion or exclusion.
4. Evaluate each option: Analyze and assess the pros and cons of each option. This evaluation should consider factors like cost, feasibility, impact, risks, and alignment with goals. Clearly state the criteria used to evaluate the options and provide supporting evidence or data where applicable.
5. Provide a recommendation: Based on the evaluation and analysis conducted, make a clear recommendation on which option is the most suitable or advisable. Justify the recommendation by linking it to the criteria used in the evaluation process.
6. Summarize the decision rationale: Summarize the key factors and considerations that influenced the decision. This should include a concise explanation of why the recommended option was chosen over the alternatives. It is important to be transparent and logical in presenting the decision rationale.
7. Communicate next steps: Discuss the actions or steps that need to be taken following the decision. This could involve implementation plans, resource allocation, or any other necessary actions to transition from the decision-making phase to the execution phase.

Who needs a decision summary:

1. Project teams: Decision summaries are crucial for project teams to ensure everyone is on the same page regarding key decisions made during the project. It helps in maintaining transparency and clarity among team members and can serve as a reference for future discussions or assessments.
2. Managers and leaders: Decision summaries are valuable for managers and leaders who need to review and understand the decision-making process within their teams or departments. It provides them with insights into how decisions were arrived at and allows them to provide guidance or support if necessary.
3. Stakeholders: Decision summaries play a significant role in keeping stakeholders informed about important decisions. It enables them to stay updated and aligned with the progress and direction of a project or organization. For stakeholders not directly involved in the decision-making process, a summary provides a quick and concise overview.

In conclusion, filling out a decision summary involves understanding its purpose, providing an overview of the decision, listing options considered, evaluating each option, making a recommendation, summarizing the decision rationale, and communicating next steps. Decision summaries are beneficial for project teams, managers and leaders, as well as stakeholders who need to be informed about key decisions.

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What is decision summary?

The decision summary is a document that provides a concise overview of a decision-making process.

Who is required to file decision summary?

Certain individuals or entities involved in decision-making processes may be required to file a decision summary. The specific requirements vary depending on the jurisdiction and regulations.

How to fill out decision summary?

The decision summary should typically include information such as the decision-making criteria, alternative options considered, rationale for the final decision, and any potential risks or concerns.

What is the purpose of decision summary?

The purpose of the decision summary is to provide a clear and transparent record of the decision-making process, helping stakeholders understand the rationale behind a particular decision.

What information must be reported on decision summary?

Information such as decision criteria, alternatives considered, rationale for decision, potential risks, and any relevant supporting data should be reported on the decision summary.