Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans When is the FSVP Compliance Deadline for Most US Importers Passed? 1.21K viewsFDA 0 Votes 1 Ans When is the Compliance Dates Passed under the Preventive Controls Rules? 1.23K viewsFDA 0 Votes 1 Ans When did FDA Proposed Extension of Label Rule Compliance Dates? 1.26K viewsFDA 0 Votes 1 Ans When did FDA Proposed to Revoke Authorized Health Claim for Soy Protein? 1.24K viewsFDA 0 Votes 1 Ans When did FDA Issued Draft Guidance for Refusal of Inspection? 1.34K viewsFDA 0 Votes 1 Ans Why are these commonly used ingredient triclosan and 23 other active ingredients in antiseptics for health care environments are prohibited? 1.30K viewsFDA 0 Votes 1 Ans What are Homeopathic Drugs? 1.25K viewsFDA 0 Votes 1 Ans Why is FDA Cracking Down on Homeopathic Drugs? 1.29K viewsFDA 0 Votes 1 Ans What are the new Enforcement Approaches to Homeopathic Drugs? 1.29K viewsFDA 0 Votes 1 Ans What are the Upcoming Changes to FDA Electronic Medical Device Reporting (EMDR) ? 1.26K viewsFDA 0 Votes 1 Ans Do generic drugs cause more side effects than brand name prescriptions? 1.61K viewsMedical Device 0 Votes 1 Ans What is a class action lawsuit? 1.46K viewsMedical Device 0 Votes 1 Ans When the FDA approves a drug can that drug be considered safe? 1.51K viewsMedical Device 0 Votes 1 Ans What is a single-use medical device? 1.55K viewsMedical Device 0 Votes 1 Ans To which single-use medical devices does this policy apply? 1.49K viewsMedical Device 0 Votes 1 Ans Can you give example(s) of when an IRB would not allow a sponsor to charge for a device? 1.60K viewsMedical Device 0 Votes 1 Ans How does an IRB decide who can present the risks/benefits of a complex device study (eg., physician or study coordinator)? What if the SC is not a medical professional? 1.60K viewsMedical Device 0 Votes 1 Ans Are there specific guidelines related to consenting children or adolescents? What is the age definition of child and adolescent? 1.61K viewsMedical Device 0 Votes 1 Ans If an investigator develops a home-grown device that will be inserted into the heart chamber during open-heart surgery to measure internal pressures, but there is no intent to diagnose, treat, cure mitigate a disease or affect the structure/function of the body (it will be used to assess different physiologic conditions to understand the pathologenesis of disease), is the research FDA-regulated? In other words, they want to develop a device for future research on heart conditions, but it does not meet the definition of a medical device. Does the IRB need to insist that this device is classified by the FDA? Or can the IRB approve the study, noting that the device is not a medical device. 1.64K viewsMedical Device 0 Votes 1 Ans When a commercial device is used in research in the population for which the device is intended, but the researcher plans to use a slightly different surgical procedure for putting the device in place does it require an IDE? 1.52K viewsMedical Device « Previous 1 2 … 185 186 187 188 189 … 283 284 Next » Question and answer is powered by anspress.net
