Clinical evaluation process of FDA and MDR

[Muhammad Farooq]

Dear seniors,
As a part of my master’s thesis, I would like to compare the clinical evaluation process of FDA with MDR. Which parameters should I consider? e,g should I include time and the cost of treatment (e.g. centralization and rigidity of the patient).
MDR: there are complete guided sections, e.g. Article 61 CHAPTER VI and Part A of Annex XIV.
FDA: when I search for FDA, the website links me to SAMD. Could you please direct me to any document that guides me through the FDA clinical evaluation process?
Thank you for your time.
(The compression would be only in general terms, not device-specific, later I will comply on two devices)

 

[Raisin picker]

Hi Muhammad,
I can't help you with FDA, but for MDR, look for MDCG documents (e.g. MDCG 2020-5, -6), and also for MEDDEV 2.7/1 rev. 4 (still partially applicable).
"time and the cost of treatment (e.g. centralization and rigidity of the patient)" are in no way related to the clinical evaluation process in general.

 

[Al_Z1]

You can look into Acceptance of Clinical Data for Medical Device Applications and Sub.
Hope, it helps.