Clinical Studies of MD and IVD in the US

#1
The Medical Device (MDR- class I) and IVD ( IVDR - Class C) will have clinical studies conducted in the UK, both will be in alignment with MDR and IVDR for entry into the EU market. Then we are looking to enter the US market, would we need to conduct clinical studies there prior to a PMA? Would clinical studies within the US speed up approval?

Any help on this would be much appreciated.
 
Elsmar Forum Sponsor
#4
Per 21CFR814:

814.15 Research conducted outside the United States.

(a) Data to support PMA. If data from clinical investigations conducted outside the United States are submitted to support a PMA, the applicant shall comply with the provisions in § 812.28 of this chapter, as applicable.

(b) As sole basis for marketing approval. A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval under this part may be approved if:

(1) The foreign data are applicable to the U.S. population and U.S. medical practice;

(2) The studies have been performed by clinical investigators of recognized competence; and

(3) The data may be considered valid without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA can validate the data through an on-site inspection or other appropriate means.

(c) Consultation between FDA and applicants. Applicants are encouraged to meet with FDA officials in a “presubmission” meeting when approval based solely on foreign data will be sought.
 

mihzago

Trusted Information Resource
#5
FDA very rarely accepts data from OUS only, unless you can show that there are no differences between the populations. Often the agency requests a smaller supporting study with subjects/data from the US.
 

mihzago

Trusted Information Resource
#7
This is great to know, what would you define as a small study? Roughly how many participants?
It really depends on your device and is a question for a statistician. I would also highly recommend getting FDA's feedback on the sampling and study design.
In general, what I mean is that let's say your pivotal trial has 1000 subjects, the "smaller" study may have 100-200, or maybe even less, if you can provide adequate justification.
 
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