What is the FRA?
The Foundation in Regulatory Affairs (FRA) credential is an assessment-based certificate. Demonstrate to your peers and employers that you understand the fundamentals of regulatory affairs by earning the FRA. The FRA exams are based on the learning objectives of certain RAPS online courses.
Who should take the FRA exam?
The FRA assessment-based certificate is designed for individuals with no regulatory affairs experience. These are individuals who are entering the regulatory profession from adjacent fields or who want to start a career in regulatory.
Why should I get the FRA?
The FRA can give you a head start in the regulatory affairs profession. It can better position you for jobs in the regulatory field.
Which RAPS Online University courses qualify for the exam?
The FRA-Introduction to Pharmaceuticals Exam covers topics from these RAPS online courses:
- The Introduction to Regulatory Affairs in the EU
- Introduction to Regulatory Affairs in the US and Canada
- Pharmaceuticals: Definition & Lifecycle
The FRA-Introduction to Medical Devices Exam covers topics from these RAPS online courses:
- The Introduction to Regulatory Affairs in the EU
- Introduction to Regulatory Affairs in the US and Canada
- Medical Devices: Definition & Lifecycle
The FRA-Global Regulatory Strategy for Medical Devices exam covers topics from this course:
The FRA-Global Regulatory Strategy for Pharmaceuticals exam covers topics from this course:
Do I have to complete the RAPS online courses to take the test?
- No, but it is recommended for individuals who need to learn the content.
How many questions are on the exams? How are the items weighted?
FRA-Introduction to Pharmaceuticals exam
- 40 questions
- 40% are about pharmaceuticals
- 30% are about regulations in the US & Canada
- 30% are about regulations in Europe
FRA-Introduction to Medical Devices exam
- 40 questions
- 40% are about medical devices
- 30% are about regulations in the US & Canada
- 30% are about regulations in Europe
FRA-Global Regulatory Strategy for Medical Devices exam
- 40 questions
FRA-Global Regulatory Strategy for Pharmaceuticals exam
- 40 questions
Each question is worth one point and there are no penalties for guessing.
How well do I need to do on the exam to pass?
Due to variances in exam form difficulty, the exact number can vary slightly. For studying purposes, we recommend you try to answer 75% of the questions correctly.
What percent of people pass?
The vast majority of individuals who have a solid understanding of the content will pass the exam.
How many attempts do I have to pass the exam? What if I fail the exam?
You have five attempts to pass the exam. After that, you may purchase the re-take exam where you will have five more attempts to pass.
How long do I have to take the exam?
You will have 60 minutes to complete your exam.
What are the key dates for the program? When can I take the exam?
You can register and take the exams on demand at any time.
Do I have to go to a testing center to take my exam?
- No. The exams are only offered online through the RAPS Learning Portal.
Is it an open book exam?
- No. You may not use any materials to help you answer the exam questions. You will need to sign an honor agreement (attestation) before taking the exam. You must promise not to receive (or provide) any assistance during the exam session.
How much does the program cost?
See the information on raps.org/FRA for this information.
How do I register and pay for the program?
Go to raps.org/FRA
What options do I have to purchase the product?
There are three ways to purchase:
- Bundle the recommended courses with the exam
- Purchase a qualifying Online University certificate program that now includes an FRA exam
- Purchase the exam a la carte
When does the product expire?
You have one year to take the exam from time of purchase.
Can I receive an extension after the exam expires?
No extensions are available for the FRA exam.
Will I have the opportunity to retest for free?
After you have reached your maximum number of attempts on the first exam, you will need to purchase another form of the exam.
When do my scores expire? Do I have to recertify?
Your scores do not expire, and you do not have to recertify to maintain the credential.
Can I get a refund if I can’t take the exam?
No. This product is non-refundable.
When will I receive my results?
Results will be provided immediately after taking the exam.
What kind of feedback will I receive?
Due to exam security, you will only be notified about your pass/fail score outcome. You will not receive further information about your score.
Do I get a digital badge after I pass?
Yes, you will receive a digital badge. You will need to activate your digital badge in order to display or share it.
Can I add the FRA acronym after my name?
While you can share your FRA digital badge, you cannot use the ‘FRA’ acronym after your name. Using letters after your name is reserved for RAPS RAC and RCC certification holders only.
How is this different from the RAC or the RCC credentials?
The FRA answers the question: did you learn it? The RAC and RCC answers the question: can you apply it? All three programs require passing an exam to demonstrate that you have met the performance standards set for each program. If you are new to the profession, consider starting with the FRA. If you have been in the profession for at least three years, consider the RCC and RAC. More information can be found on www.raps.org.
Do I get RAC or RCC recertification credits for taking the exam?
No, you will not receive any RAC or RCC recertification points for taking the FRA exam.
What if I want to send multiple people through the program, is there a discount?
No, not at this time.
I took the online course and passed the course final assessment. Why do I need to take another exam?
- The FRA exam is more comprehensive and rigorous than the RAPS online course final assessment.
Who should I reach out to if I have questions?