Pre market approval pma - Study guides, Class notes & Summaries

US RAC Review Questions RAPS Modules With Complete Solutions Latest Update 2023/2024 (Verified Answers). drug, which of the following studies would typically be conducted first: A) 1 month repeat dose toxicology study B) Single dose escalation PK study in healthy volunteers C) Multiple dose PK study in healthy volunteers D) Single dose escalation study in hypertensive patients:  B) Single dose esca- lation PK study in healthy volunteers 3. A sponsor must report an unexpected, fat...

When is an NDA annual report due? - ANS-60 days after the anniversary date of U.S. approval of the application. NDA Reporting Period ? All Blood and HCT/P Problems - ANS-45 calendar days of Fatal/Life threateneing/Disabling/Surgical Intervention and hospitalization Reporting Period? Postmarket Device Death, Serious Injury, Malfunction - ANS-Within 30 calendar days of awareness Reporting Period? Device Special FDA, or Remedial Action to Prevent Death/Harm - ANS-Within 5 work days of aw...

Class II Biological indicators are too. - ANSWER Chemical indicators are FDA ____ Devices They harbor bacteria - ANSWER Watches and other jewelry should NOT be worn in the Central Service department work areas because: De-ionization Process of ions being removed from water with an electrical charge - ANSWER System used to treat the final rinse water used for cleaning is: FDA regulates: Registration and listing medical device reporting, tracking, corrections, and removals quality ...

T or F - All medical terms consist of each of the following word elements: prefix, root and suffix. - ANSWER FALSE T or F - There are two parts to the ear: the outer ear and the inner ear. - ANSWER FALSE T or F - Cells are the basic units of all living organisms and are the smallest element that can live, grow and reproduce. - ANSWER TRUE What type of bacteria develops spores? - ANSWER gram-positive AND gram-negative What percentage of microorganisms are harmful to humans because the...

Biodesign quizzes with Answers What branch of the US government is responsible for the regulation of medical devices? - Answer-Department of Health and Human Services What class of medical devices does an adhesive bandage belong to? - Answer-Class I What class of medical devices does a surgical drape belong to? - Answer-Class II True or False? All medical devices are subject to general controls. - Answer-True Which of the following are considered to be the minimal requirements for ...

SOCRA CCRP Exam (2023/2024) Rated A Timeline of Historical Events Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report respect for persons, beneficence, justice Application of Respect for Persons informed consent (autonomy, choose for themselves) Application of Beneficence risk/benefit analysis Application of Justice appropriate selection of patients (equality) Language Level ICF 6th-8th grade 8 basic elements of ICF 1. purpose, ...

Class II Biological indicators are too. - ANSWER Chemical indicators are FDA ____ Devices They harbor bacteria - ANSWER Watches and other jewelry should NOT be worn in the Central Service department work areas because: De-ionization Process of ions being removed from water with an electrical charge - ANSWER System used to treat the final rinse water used for cleaning is: FDA regulates: Registration and listing medical device reporting, tracking, corrections, and removals quality ...

IAHCSMM CRCST EXAM CORRECT 10Statute - ANSWER A written law adopted by a legislative body that governs a city, county, state or country Regulation - ANSWER Rules issues by administrative agencies that have the force of law Standard - ANSWER A uniform method of defining basic parameters for processes, products, services, and measurements Regulatory Standards - ANSWER A comparison benchmark that is mandated by a governing agency. Noncompliance with regulatory standards may lead to citatio...

RAC Prep Medical Devices Exam Prep 2023 with complete solution device - instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or related article: -recognized by NF-USP -intended for use in diagnosis of disease or other condition, or in the cure, mitigation, treatment or prevention of disease -intended to affect the structure or function of the body -not achieving any primary purpose through chemical action -not dependent on metabolism for primary purpose E...

IAHCSMM practice exam 100% co T or F - All medical terms consist of each of the following word elements: prefix, root and suffix. - ANSWER FALSE T or F - There are two parts to the ear: the outer ear and the inner ear. - ANSWER FALSE T or F - Cells are the basic units of all living organisms and are the smallest element that can live, grow and reproduce. - ANSWER TRUE What type of bacteria develops spores? - ANSWER gram-positive AND gram-negative What percentage of microorganisms ar...