Med Device Assignment

Phase I

Select a medical device that is regulated by the FDA. It is strongly recommended you select one that you can literally hold, manipulate, and research online.  For ideas, go to your medicine cabinet or your local grocery or pharmacy store.

Describe the device using :

  1. Visuals  – (examples – drawn images, photos), provide 5-10 quantitative measurements of the device (examples – volume, length, width, rigidity, flex angles, etc etc).
  2. Materials – most devices use multiple materials for different purposes.  Describe one material for the device by name (e.g. surgical grade stainless or stainless 304, 316, 420, etc). Then select at least 3 parameters used to describe the material (example – compensation, yield strength, hardness (usually multiple values)).

Phase II

Further describe your device!

Regulatory:

  1. Complete this exercise as an example.  Go to the 510(k) database here and search “Johnson and Johnson” under applicant name and “bandage” under device name.
  2. Nothing quite right comes up right?  Now try “Johnson & Johnson” and “bandage.”  It’s quite a sensitive database, keep that in mind when are searching for your own!
  3. Now that you have the search results, find out more about liquid bandages (510(k) K062602) and compare to 510(k) K782003!  Take note of device classification, intended use, and marketed device to which equivalency is claimed!
  4. Apply this knowledge to your device and start searching the database for how your device is regulated!
  5. Write a letter/email to FDA requesting a meeting for your device.  Include the reason for the meeting, your intended clinical use, your device classification, and identify predicate devices.  Table 4.2.1 in BioDesign is very good as well as the appendix letter.  Make sure you are asking the right person at FDA!

Commercial

  1. What is the brand name, product name, company name that markets the device, and some marketing claims for the device?  Are the marketing claims similar or the same as the FDA intended use claims?
  2. Give a ball park figure for how many devices might be used per year?  For example if your device is an orthopedic soft-good, how many procedures will require this device per year?