FDA MDR COST ESTIMATES EXPECTED TO BE FOCUS OF REP. UPTON'S NEXT ROUND OF QUESTIONS ON MDR RULE; AGENCY STANDS BY $600 PER-ESTABLISHMENT FIGURE
This article was originally published in The Gray Sheet
Rep. Fred Upton (R-Mich.) is expected to continue scrutinizing FDA's cost estimates for complying with the medical device reporting rule. Upton is drafting a letter to the agency that will express dissatisfaction with several responses FDA gave to a series of MDR-related questions posed by the legislator in May. One of the likely focal points of the upcoming letter will be the agency's defense of its cost estimates.
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