Free Tips – Florida Designated Representative (CDR) Exam Prep

Simply studying for the Florida Certified Designated Representative (CDR) examination isn’t enough!

  1. Many candidates only study the exam subjects and content, then take what’s considered a difficult exam. Some of these same candidates don’t pass the exam.
  2. As you prepare for the examination, you have to recognize that the official exam of 40 multiple choice questions (in 1.5 hours) is the critical step toward moving forward in the licensing application process. That’s roughly 2.5 minutes per question, hardly enough time to rethink or rehash the answer choices.
  3. The keys to exam preparation include: reinforcing complete mastery of the exam content, reducing your anxiety, gaining confidence, and developing test taking familiarity, rhythm, and pace.

In the past, I’ve taken many high pressured timed exams, including healthcare clinical and web technology certification exams. In my experience, I learned that scouring the universe for any and all available practice exams helped me tremendously to prepare for the official examinations. I strongly recommend practice exams.

The Key Learning. Only by preparing for the most important part of the examination process, that is, actually taking the test, can you increase the odds of successfully passing the exam. As Vince Lombardi (football coaching legend) says, “Practice does not make perfect. Only perfect practice makes perfect.” So we recommend candidates take as many practice exams before sitting for the official state exam.

Go to The Designated Representative and Exemptee Training Website

Design Considerations for Devices Intended for Home Use – FDA Guidance

Medical Device Development Pathway

Read the full guidance:  Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff (PDF – 205KB)

As stated in the guidance, “This guidance is intended to assist manufacturers in designing and developing home use devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Devices used in the home or other non-clinical environments are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This guidance identifies several factors that manufacturers of home use devices should consider, especially during device design and development, and provides recommendations for minimizing these unique risks.”

Go to The Designated Representative and Exemptee Training Website