What is a modular pma - Study guides, Class notes & Summaries

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 loc...

Number of Days for review of PMA - ANSWER-180 days How many routes to a PMA? - ANSWER-3 Routes: 1. 2 3 What makes a PMA unique (vs 510k)? - ANSWER--Must include section on clinical investigations on human subjects -Must include a seperate volume on QS for review by CDRH/OC (office of compliance) -Includes a premarket QMS inspection -Sponsor should update the PMA periodically during review (if a big update, might reset the clock) *SSED vs 510k summary *no substantial equivalence with...

Republic AQP Knowledge Validation Study Guide E170/175 (Rev4), E170 systems study guide Republic AQP Knowledge Validation Study Guide E170/175 (Rev4), E170 systems study guide TYPES OF OPERATIONS -Day or Night in following conditions 1. Visual Flight (VFR) 2. Instrument Flight (IFR) 3. Icing Conditions 4. CAT I 5. CAT II 6. RVSM 7. Extended Overwater Operation (EOW) *175 only when properly equipped Maximum Ramp Weight (MRW) E-170 82,364 lbs Maximum Takeoff Weight (MTW) E-170 82...