Pma 2 - Study guides, Class notes & Summaries

What did the safe medical device act do? Answer - Extended AE reporting to user facilities, required 510ks with SE, recall authority General controls Answer - Establishment reg and device listing, GMP, labels, clearance before marketing What controls are required by the 3 US classes? Answer - Class 1 - general controls. Class 2- General and special controls (which include special labeling, PMS, and performance data) Class 3- general, special, and PMA What are special controls? Answer...

A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is the manufacturer preparing to submit to FDA? 0 A PMA 1 A Special 510(k), 2 An Individual Device Exemption (IDE), 3 An Annual Report for a PMA - A Special 510(k) A company wishes to expand existing labeling for a medical device to include a new indication for use. What action should the regulatory professional take FIRST? - Contact t...

SPMA 2P96 - Exam #1 questions with accurate solutions

CPMA 2024/25 LATEST EXAM UPDATE WITH MULTIPLE CORRECTLY ANSWERED QUESTIONS ALREADY GRADED A+ |WITH APPROPRIATE RATIONALES| (VERIFIED)

SPMA 2P65 - Exam Review (updated)questions with correct answers

The first initial, last name and credentials - ANSWER What is the minimum signature assignment(s) of the author of an entry in the medical record? Personal biographical data and consent for treatment or authorization for treatment form - ANSWER Based on Joint Commission accreditation guidance for personal data, what two elements must be evident in the medical record Surgical assistants - ANSWER As an auditor, who of the following would NOT be expected to submit operative notes? Discard ...

APMA 2120 Final Exam Review(updated already passed)

SPMA 2P98 event management questions with correct answers graded A+

Documentation of the patient's postmenstrual age correct answer: (PMA ¼ gestational age, measured from the time of the last menstrual period 1 chronological age) at the time of recording •The LMP occurs approximately 2 weeks before conception.). correct answer: a)Term ¼ 37 up to 44 weeks of PMA b)Preterm ¼ less than 37 weeks of PMA c)Post term ¼ 44 to 48 weeks of PMA Documentation of neuroactive medications at the time of recording. This includes correct answer: sedatives, hypn...

Temporal lobe epilepsy accounts for what % of all adult patients with epilepsy? 60% The majority of seizures in the intensive care unit are: non convulsive What type of resection is associated with medial temporal sclerosis? Temporal lobectomy The safest AED for pregnant women Lamictal Hypsarrhythmia is a pattern most often associated with Infantile spasms Expressive speech Broca's area Vagus nerve stimulators are approved for use in patients with...