BLD 313 EXAM 2 QUESTIONS AND ANSWERS WITH COMPLETE SOLUTIONS GRADED A++

BLD 313 EXAM 2 QUESTIONS AND ANSWERS WITH COMPLETE SOLUTIONS GRADED A++ FDA Multifaceted governmental agency. In charge of food and drug, also moved on to lab work in 60's. In vitro diagnostics any product, instrument, reagent or system used in diagnosis FDA General Controls Misbranding and labeling, GMP (Good Manufacturing Practice) Class I i. Least scrutiny ii. Must be registered iii. Correct labeling iv. Efficacy and safety of product Class II i. Most common ii. All the Class I controls iii. A predicate that has undergone Class III iv. Documentation of factors different than predicate v. Method evaluation Class III i. something that is unique and has never been done before, no idea if it's going to work or not or if safety is up to par ii. Highest degree of scrutiny iii. No predicate iv. Require IDE and PMA IDE (Investigational Device Exemption) This is a deal with the FDA -- collaborate with the FDA No standardize plans A proposal, investigation plan Qualifications of investigators, Review of Literature, Completion of IRB, Business plan, Environmental Impacts, Legal infringements, CLIA complexity IRB Internal Review Board - in charge of ethics PMA (Non-Clinical Aspects) Analytic performance: Precision, Accuracy, Shelf-life, robustness, toxicology Pre-analytic variables: Types of specimens, specimen characteristics that may affect results PMA (Clinical) Cllinical trials (All of them go through this) = diagnostic performance, user complexity, patient feedback Post Market Surveillance In the form of an adverse outcomes report -- becomes manufacturer's responsibility to report adverse outcomes to the FDA LDT's (Laboratory Developed Tests) Only done for Class II tests, the workaround for providing tests which are not FDA approved. Regulations and costs are cut down for these LOW VOLUME tests because it is beneficial to develop them ASR Analyte Specific Reagent LDT without ASR Analytic method that uses NO reagent. EXAMPLES: Mass Spec, Basic Chemistry, Chromatography LDT with ASR Assay is already well established with predicates (LDT's are for Class II only). Based on modification of predicate method with change in "active ingredient" or reagent specific to that analyte String one attached to LDT Test can only be performed in lab where development occurred. Other labs can do similar tests but must go through same LDT process. This lab gains reference lab status --- Esoteric testing -- low volume, low prevalence of disease Other labs can go to you for this specific test String two attached to LDT Active ingredient reagent must be manufactured under FDA APPROVED GMP guidelines. Research only use reagents String three attached to LDT