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I am working with a foreign manufacturer who has a cleared class II medical device (including electronic components). They created a US entity to become their initial importer in the US. Both the foreign and US entities are registered with the FDA. As this is a large equipment, they would prefer to ...

Dear colleagues, For a hip prothesis, a 510(k) must include the complete device: femoral stem, head and acetabular cup, even if the stem has previously been cleared. The manufacturer of a new acetabular cup, for example, must demonstrate compatibility with an existing femoral stem and head. Now, ...

With the various amendments to 21 CFR part 803, I am a little bit confused as to what a foreign device manufacturer must do: Reporting requirements (of a reportable event): * Medwatch form within 30 days * or a 5 day Medwatch form report. Does a foreign (or domestic) manufacturer still complete ...

A foreign manufacturer and sponsor of a US clinical study (IDE) has currently no product commercialized in the United-States, therefore, has no US Agent. I will use the term of US Sponsor although this does not seem to be an official word and is not defined by regulations. As part of the IDE, ...