On Jan. 15, HHS published a notice proposing to exempt the mobile health devices from the regulation requirement. The FDA said there is no evidence that HHS consulted with, involved or even notified the FDA before issuing the notice, an April 16 release said.
The January notice said HHS felt the lack of adverse events in unclassified medical devices determined regulation requirements were “no longer necessary to assure the safety and effectiveness of those devices.”
Upon further review, HHS and the FDA determined the notice was published without scientific support, contained errors and ambiguities, and was overall flawed.
HHS did not consult or notify the FDA before publishing the notice.
The FDA said: “It is particularly important that FDA have at least some level of involvement in this type of an action given the expertise needed in evaluating whether a submission under the [regulatory act] is necessary to assure the safety and effectiveness of a device.”
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