Exam (elaborations)
RAC devices practice exam Questions and Answers (Latest Update 2025)
- Course
- Institution
RAC devices practice exam Questions and Answers (Latest Update 2025)
[Show more]
Content preview
RAC devices practice exam Questionsand Answers (Latest Update 2025)
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 - Correct Answer ✅ 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? - Correct Answer ✅
Contact the review division to determine whether a 510(k) or
PMA should be prepared.
A company is submitting a PMA for a permanent implant. The
company has performed biocompatibility testing based on
ISO requirements and believes the package is complete.
Which of the following testing does the company absolutely
need to demonstrate long-term safety of its device:
, RAC devices practice exam Questions
and Answers (Latest Update 2025)
0 Intracutaneous irritation,
1 Genotoxicity,
2 Acute toxicity,
3 Carcinogenicity - Correct Answer ✅ Carcinogenicity
If a device fails to comply with any paragraph of the QSR is it
adulterated? - Correct Answer ✅ Yes
What source should the regulatory professional consult to
determine when a product's patent and exclusivity will
expire?
0 FederalRegister
1 TheOrange Book,
2 Patentand Trademark Office,
3 CopyrightOffice - Correct Answer ✅ The orange book
An FDA reviewer contacts a regulatory professional with a
lengthy list of questions regarding a submitted 510(k)
application. Some of the information is not readily available
and may require additional data collection. What is the BEST
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 Allivia. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $13.49. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
83637 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now