RAC Prep Medical Devices Exam Prep 2023 with complete solution

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 Exempt device - Exempt from 510(k) if: -Diagnostic device that was in distribution before 28MAY76, not a transitional device -is noninvasive -does not introduce energy into subject -not used for diagnosis without confirmation from another procedure More than 800 generic class I devices and 60 class II devices (documented in 21CFR 862-892) -Does not require clinical trials -Also may be exempt from GMPs (noted in regulation) Devices used for collecting, processing, storing and administering blood products - Approved by CBER as devices (510(k) or PMA) finished device - any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized software - considered a device when used for a medical purpose without being part of a device's hardware mobile medical app - considered a device when it meets the definition of a device accessory - may be used with multiple parent devices or has unique stand-alone functions class I device - General controls to ensure safety & effectiveness. -Low-risk device requiring -Usually exempt from 510k (93%) and QSR -Examples include exam gloves, hospital beds, lab equipment, surgical instruments, bandages Class II device - General and special controls to ensure safety and effectiveness. -Requires 510(k) unless exempted (8%); may require clinical trials. -Examples include blood glucose test systems and infusion pumps, catheters, blood pressure cuff, ELISAs Class III device - Requires general controls, special controls and premarket approval (PMA); -includes devices that are life-sustaining, life-supporting or pose significant potential for risk to patient; PMAs almost always require clinical trials. -Examples include heart valves, breast implants, orthopedic implants, tubal occlusion devices transitional devices - Regulated as drugs before 1976 and are now governed by a PMA -Reclassification to II or I takes significant resources Reclassification of transitional devices - FDA must complete 5 tasks -Task A: collect scientific info -Task B: convene Medical Device Advisory Panel -Task C: Issue proposed order for reclassification -Task D: Review and consider public comments -Task E: issue final order Preamendment device - Devices legally marketed by a US firm before May 28, 1976 that have not changed or been modified significantly since approval and for which FDA has not issued a regulation requiring PMA. -Must have same intended use and same owner -New intended use = 510(k) required FDA Form 3752 - Pre-amendment device determination request -Must demonstrate the device was labeled, promoted and distributed for a specific use and that use has not changed. 513(g) Request for Information - Requires a letter with device description and fee payment FDA will provide the following within 60 days: -the generic type of device (e.g., classification regulation) that the requester's device appears to be within (if any); •-the class of devices within that generic type (and if there is more than one class within that generic type, the particular class within which the requestor's device appears to fall); •-whether a PMA, 510(k), or neither is required in order to market devices of the particular class within that generic type; •-other requirements applicable to devices of the particular class within that generic type; •-whether a guidance document has been issued regarding the exercise of enforcement discretion over the particular class of devices within that generic type; •-whether additional FDA requirements may apply, such as those applicable to radiation-emitting products. -Not final agency action, but responsive info General device controls - Apply to ALL medical devices unless exempted in classification -Establishment registration -Medical device listing -21CFR 820 compliance (QSR) -Labeling devices per 21CFR 801 or 809 -Notification (recalls) -Records and reports -Submitting 510k before marketing Special device controls - -Special labeling requirements -mandatory performance standards -patient registries for implantable devices -Post marketing surveillance activities Premarket Approval (PMA) - -Must receive FDA approval before marketing -Contains scientific evidence of safe and effective -Typically takes 180 days for FDA to review Review steps as follows: -acceptance review (15 days) -review manufacturing section for QSR compliance -filing review and decision (45 days) -Day 100 meeting -PAI -BIMO audit of clinical data -Substantive review (90 days) -nonclinical -clinical -panel meeting (when needed) -QSR/BIMO clearance -safety/effectiveness -final decision Total 180 days