RAC Devices Exam Questions and Answers 2022 with Complete Solutions
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Course
RAC Devices
Institution
RAC Devices
RAC Devices Exam Questions and Answers 2022 with Complete Solutions
What is a modular PMA? - Answer- Same content as a traditional PMA but the sections are submitted and reviewed as the work is completed.
What is a PDP? - Answer- Product Development Protocol. Alternate to a PMA where you p...
RAC Devices Exam Questions and
Answers 2022 with Complete
Solutions
What is a modular PMA? - Answer- Same content as a traditional PMA but the sections
are submitted and reviewed as the work is completed.
What is a PDP? - Answer- Product Development Protocol. Alternate to a PMA where
you plan the design and timelines for product development up front with FDA and send
updates
When is a PMA supplement needed? - Answer- Significant changes to product such as
indications, labels, mfg location, mfg method or quality, sterilization, packaging,
performance, stability
Types of PMA follow ups - Answer- Annual report (doesn't impact S&E), 180 day (for
significant changes), Special PMA (for changes that increase S&E like added controls
or removal of misleading information), 30 day notice (changes to mfg procedure or
method that impact S&E)
When can you implement a 30 day change? - Answer- Within 30 days of submission if
no reply
Who must submit AE reports? - Answer- Mfrs, user facilities, importers, distributors
What is a user facility? - Answer- Hospital, surgery office, nursing home. Medical office
that is not a physicians office
What are the different AE reporting timelines? - Answer- User facilities have 10 days if
there is a death, 10 for serious injury, annual reports. Importers have 30 days. Mfrs
have 30 days for death/serious injury, or 5 for a threat to public health
Recall - Answer- Removal of product from the market
Correction - Answer- Fix of product in the field
Removal - Answer- Removal of product to undergo a correction
, Market Withdrawal - Answer- When a product has a minor violation that is not subject to
FDA legal action. The firm removes the product from the market or corrects the
violation.
Reminder labeling should not include - Answer- disease awareness info
Off label info can be shared if - Answer- the device is cleared/approved and the info
presented is part of a peer reviewed journal, not risky, not misleading, and not data from
a competitor. Must state FDA has not okayed the new information
What is a notice of violation? - Answer- Label enforcement action that is a minor letter to
stop using certain materials
What is a warning letter? - Answer- FDA letter addressed to CEO that requires you to
stop use and do corrective actions
What is a consent decree? - Answer- An agreement with FDA to do actions under sever
restriction until compliant
What device type is a device with an ancillary drug? - Answer- Device
What device type is a drug that works with a device? - Answer- Both drug and device
What type is a device that administers drugs? - Answer- Device
What type is a device containing a drug? - Answer- Both drug and device
CD 2010/227/EU - Answer- EU IVDR
Regulation EU 2017/745 - Answer- EU MDR
Requirements for custom devices - Answer- Do not need conformity assessment. But
do need to meet MDR or MDD requirements. Do not have to be CE marked.
2 types of devices exempt from EU conformity assessment - Answer- custom devices
and devices intended for clinical use
Requirements for devices intended for clinical use - Answer- Must meet requirements
for conformity assessment but cannot have a CE mark
Directive 90/385/EEC - Answer- Active Implantable AIMDD
Directive 98/79/EC - Answer- IVDD
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