CDRH has been busy for the past two months in an effort to bring direct-to-consumer genetic test services into its regulatory fold, but Center Director Jeff Shuren acknowledged to a House subcommittee last week that the agency was slow to tackle the matter.
'We Should Have Acted Sooner' On DTC Gene Tests, Shuren Tells Lawmakers
By Sue Darcey
CDRH has been busy for the past two months in an effort to bring direct-to-consumer genetic test services into its regulatory fold, but Center Director Jeff Shuren acknowledged to a House subcommittee last week that the agency was slow to tackle the matter.
"If there's any issue here with the FDA, quite frankly, I'll say this - why didn't we act sooner? We should have acted sooner," Shuren told the House Energy and Commerce Oversight and Investigations Subcommittee July 22.
Shuren was responding to questions from Rep., Michael Burgess, R-Texas, who pointed out that FDA had sent Pathway Genomics a non-public letter in June 2009 questioning whether the firm's genome screening services qualified as a device, but did not take more direct public action until this May.
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