RAC Medical Devices Exam Questions and Answers With Complete Solutions
193 views 6 purchases
Course
RAC
Institution
RAC
RAC Medical Devices Exam Questions and Answers With Complete Solutions,RAC Medical Devices Exam Questions and Answers With Complete Solutions,RAC Medical Devices Exam Questions and Answers With Complete Solutions,RAC Medical Devices Exam Questions and Answers With Complete Solutions
RAC Medical BESTMAXSOLUTIONS 1 1 RAC Medical Devices Exam Questions and Answers With Complete Solutions A Special 510(k) relies on the following information: a) Design control documentation b) Guidance documents c) Consensus standards d) All of the above [Ans: - d) All of the above A Special 510(k) verifies and validat es that a device meets Design Controls by all of the following EXCEPT: A. Ensuring that design outputs meet design inputs B. Ensuring that devices conform to defined user needs and intended uses C. Conforming to the QS Regulation, CFR Part 820 D. Claiming substantial equivalence to a competitor device [Ans: - D. Claiming substantial equivalence to a competitor device (For a Special 510(k), you must claim equivalence to the applicant's own marketed device). A design or labeling change to an existing device (including certain changes to the indications for use) may be appropriate for a Special 510(k) when: A. The proposed change is submitted by the manufacturer legally authorized to market the existing device, B. Performance data are unnecessary, or if perfo rmance data are necessary, well -
established methods are available to evaluate the change, and C. All performance data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format D. All of the above [Ans: - D. All of th e above FDA believes that well -established methods for a Special 510(k) may include which of the following: RAC Medical BESTMAXSOLUTIONS 2 2 A. Lesser -known test methods that can be proven effective by the manufacturer B. Methods found in an FDA -recognized voluntary consensus standard or FDA guidance document C. Full test reports including methods D. Methods found acceptable by FDA through a c ompetitor's 510(k) -clearance or premarket application (PMA) approval [Ans: - B. Methods found in an FDA -recognized voluntary consensus standard or FDA guidance document Device manufacturers may choose to submit an Abbreviated 510(k) when the submission re lies on any of the following EXCEPT: A. FDA guidance document(s) B. Design Control validation and verification C. Demonstration of compliance with special controls for the device type, either in a device -specific classification regulation or a special cont rols guidance document D. Voluntary consensus standard(s) [Ans: - B. Design Control validation and verification If you are submitting a 510(k) to FDA that includes a summary of compliance with special controls, you are submitting a: A. Special 510(k) B. Traditional 510(k) C. Abbreviated 510(k) D. de novo 510(k) [Ans: - C. Abbreviated 510(k) (an Abbreviated 510(k) includes a summary report illustrating compliance to special controls or alignment with guidance documents or voluntary consensus standards) If you are including in your 510(k) a declaration of conformity with voluntary consensus standards, you are submitting a: A. Special 510(k) B. Traditional 510(k) C. Abbreviated 510(k) D. Any of the above
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Bestmaxsolutions. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $10.00. You're not tied to anything after your purchase.
