User Account

All Pages

Testing required from manufacturer in submission

Assignment Help Science
Reference no: EM133274668

Question

One of the differences between filing a Traditional 510k versus a Special 510k is the testing required from the manufacturer in the submission. The Traditional 510k requires all the testing to be provided to the FDA where the Special only requires a summary of the testing. Do you think this is a good idea to allow manufacturers to "police" themselves by only submitting summaries in a Special 510k ? Why or why not?

Reference no: EM133274668

Questions Cloud

Participants in health care quality management activities : Using PowerPoint Describe the following participants in health care quality management activities:
Assessment of patient safety culture : A baseline assessment of patient safety culture and its associated factors from the perspective of critical care nurses: Results from 10 hospitals.
Thinking It Through : Do you think Linda should have been considered responsible for the error if she had followed the orders exactly?
Controls on advertising and promotion of prescription drugs : OPDP's role in prescription drug advertising and promotional activities; FDA's guidance and controls on advertising and promotion of prescription drugs;
Testing required from manufacturer in submission : One of the differences between filing a Traditional 510k versus a Special 510k is the testing required from the manufacturer in the submission.
What body processes are affected by altered perfusion : What body processes are affected by altered perfusion? what are the expected functions of those processes?
Identify priority problems for this junetta cooper : In the scenario, the nurse needs to identify priority problems for this Junetta cooper. What are at least 2 priority problems?
Direct method of medication adherence : What is the difference between direct method of medication adherence and indirect method of adherence.
Promote better nutritional health in your community : What dietary changes would you recommend to promote better nutritional health in your community?

Reviews

Write a Review

Science Questions & Answers

  Journal of pharmaceutical sciences

This journal is a scientific publication of Indian Pharmaceutical Association and highlights various bright points of it.

  Optical fibres

This document discuss about the main attributes and characteristics of optical fibres.

  Micro organisms

This project report reveals the fact and proves a specific objective mentioned to be studied upon.

  Describing histology of an organ

The discussion of the technique should include a literature review on the evolution of the technique.

  Interpret the sensitivity of mammography

Calculate and interpret the sensitivity of mammography. Diagnostic test with Sensitivity 50%, Specificity 50% and prevalence 50%. Crude mortality rate. Damage caused by motor vehicle accidents.

  Discuss the role that science plays in your daily life

Role that science plays in your daily life and Integrity, Intensity, Innovation, and involvement in scientific field

  Prepare a flexible budget gator divers

Prepare a Flexible Budget Gator Divers is a company that provides diving services such as underwater ship repairs to clients in the Tampa Bay area.

  Neurological disorders

Designing a neuroprosthesis for the neurological disorders

  Complexity of cell surfaces

Lipid rafts provide another example of the complexity of cell surfaces in both their structural character and biologic functionality. Please explain the nature of these structures and their functionality.

  Exploratory activity on bird beaks

Describe how natural selection and evolution are demonstrated by this activity

  Spatial and temporal variation of heat content in the upper

In this study the temporal and spatial variation of heat content in the upper 70m layer of the Arabian Sea was for a period of 1991 to 2008 have been attempted.

  Earthquake databases

Earthquake Databases

Free Assignment Quote

Assured A++ Grade

Get guaranteed satisfaction & time on delivery in every assignment order you paid with us! We ensure premium quality solution document along with free turntin report!

Submit Assignment

Academics

Major Subjects

Majors

Get In Touch

whatsapp: +1-415-670-9521

Phone: +1-415-670-9521

Email: [email protected]

TERMS & POLICIES

HELP & SUPPORT

All rights reserved! Copyrights ©2019-2020 ExpertsMind IT Educational Pvt Ltd