Exam (elaborations)
RAC devices practice exam questions and answers
- Course
- Institution
RAC devices practice exam questions and answers
[Show more]
Content preview
RAC devices practice exam questionsand answers
A iimedical iidevice iimanufacturer iiis iipreparing iia iisubmission iithat iirequires iia
iiDeclaration iiof iiConformity iiwith iidesign iicontrol iirequirements. iiWhat iitype iiof
iisubmission iiis iithe iimanufacturer iipreparing iito iisubmit iito iiFDA?
0 iiA iiPMA
1 iiA iiSpecial ii510(k), ii
2 iiAn iiIndividual iiDevice iiExemption ii(IDE), ii
3 iiAn iiAnnual iiReport iifor iia iiPMA ii- iiAnswers ii-A iiSpecial ii510(k)
A iicompany iiwishes iito iiexpand iiexisting iilabeling iifor iia iimedical iidevice iito iiinclude iia
iinew iiindication iifor iiuse. iiWhat iiaction iishould iithe iiregulatory iiprofessional iitake
iiFIRST? ii- iiAnswers ii-Contact iithe iireview iidivision iito iidetermine iiwhether iia ii510(k) iior
iiPMA iishould iibe iiprepared.
A iicompany iiis iisubmitting iia iiPMA iifor iia iipermanent iiimplant. iiThe iicompany iihas
iiperformed iibiocompatibility iitesting iibased iion iiISO iirequirements iiand iibelieves iithe
iipackage iiis iicomplete. iiWhich iiof iithe iifollowing iitesting iidoes iithe iicompany iiabsolutely
iineed iito iidemonstrate iilong-term iisafety iiof iiits iidevice:
0 iiIntracutaneous iiirritation, ii
1 iiGenotoxicity, ii
2 iiAcute iitoxicity, ii
3 iiCarcinogenicity ii- iiAnswers ii-Carcinogenicity
If iia iidevice iifails iito iicomply iiwith iiany iiparagraph iiof iithe iiQSR iiis iiit iiadulterated? ii-
iiAnswers ii-Yes
What iisource iishould iithe iiregulatory iiprofessional iiconsult iito iidetermine iiwhen iia
iiproduct's iipatent iiand iiexclusivity iiwill iiexpire?
0 iiFederalRegister ii
1 iiTheOrange iiBook, ii
2 iiPatentand iiTrademark iiOffice, ii
3 iiCopyrightOffice ii- iiAnswers ii-The iiorange iibook
An iiFDA iireviewer iicontacts iia iiregulatory iiprofessional iiwith iia iilengthy iilist iiof iiquestions
iiregarding iia iisubmitted ii510(k) iiapplication. iiSome iiof iithe iiinformation iiis iinot iireadily
iiavailable iiand iimay iirequire iiadditional iidata iicollection. iiWhat iiis iithe iiBEST iicourse iiof
iiaction iifor iithe iiregulatory iiprofessional? ii- iiAnswers ii-Send iia iiletter iiwith iianticipated
iiresponse iitime.
, An iiIVD iisubmission iicould iibe iisubmitted iias iia(n):
A. iiNDA
B. iiBLA
C. ii510(k)
D. iiBLA iior ii510(k) ii- iiAnswers ii-BLA iior ii510(k)
A iicompany iiintends iito iiadd iian iiindication iifor iiuse iito iia ii510(k) iidevice iithat iiis
iicurrently iibeing iimarketed, iibut iihas iinot iiyet iibeen iidistributed. iiWhich iitype iiof
iisubmission iiis iimost iiappropriate?
A. iiA iiPMA ii
B. iiAn iiInvestigational iiDevice iiExemption
C. iiA iiSpecial ii510(k)
D. iiA iitraditional iior iiabbreviated ii510(k) ii- iiAnswers ii-D. iiA iitraditional iior iiabbreviated
ii510(k)
What iisource iishould iithe iiregulatory iiprofessional iiconsult iito iidetermine iiwhen iia
iiproduct's iipatent iiand iiexclusivity iiwill iiexpire? ii- iiAnswers ii-The iiOrange iiBook
A iiregulatory iiprofessional iiis iinegotiating iiwith iithe iiFDA iion iia iiproduct's iifinal iilabeling.
iiThe iicompany's iimanagement iiis iiadamant iiabout iiincluding iia iiclaim iiin iithe iilabeling,
iiwhile iithe iiFDA iiis iiproposing iia iimore iirestrictive iiclaim. iiWhat iiis iithe iiregulatory
iiprofessional's iiBEST iicourse iiof iiaction? ii- iiAnswers ii-Negotiate iiwith iithe iireview
iidivision.
A iimedical iidevice iithat iihas iijust iireceived iimarketing iiapproval iioutside iithe iiUS iiis iito
iibe iishipped iifrom iithe iiUS iito iia iiforeign iidistributor iiof iiCompany iiXYZ. iiCompany iiXYZ
iicontacts iithe iiforeign iidistributor, iiwho iiconfirms iithe iiproduct iihas iinot iiyet iibeen
iishipped iiand iiis iistill iiat iiits iiwarehouse iiin iithe iiUS. iiCompany iiXYZ iirequests iithe
iiforeign iidistributor iireturn iithe iimedical iidevice iiimmediately. iiThe iienforcement iiactivity
iidescribed iiis iian iiexample iiof iia:
A. iiMarket iiWithdrawal
B. iiStock iirecovery
C. iiClass iiI iirecall, ii
D. iiClass iiIII iirecall ii- iiAnswers ii-Stock iirecovery
When iia iimanufacturer iiis iiperforming iidesign iivalidation iiactivities, iiwhich iielement iiis
iiNOT iiincluded iias iia iirequirement iiunder iiQSR's iidevice iidesign iivalidation iisection? ii-
iiAnswers ii-Translation iiof iidevice iidesign iiinto iiproduction iispecifications.
If iia iidevice iifailure iiis iioccurring iiwith iigreater iithan iiexpected iifrequency iiand
iiinvestigation iiof iithe iiproblem iiimplicates iiimproper iiuse iiby iithe iiend iiuser, iiwhich iiof
iithe iifollowing iishould iioccur?
A iiThe iilabeling iiis iirevised
B iiThe iiproduct iiis iirecalled
C iiThe iiproduct iiis iiredesigned, ii
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 millyphilip. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $10.49. 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