A new provision in the Senate FDA user fee and reform bill would prevent issuance of an FDA guidance on the regulation of mobile medical applications software until the agency submits a report to Congress.
Latest Senate FDA Reform Bill Would Delay Guidance On Mobile Health Apps
The Senate user fee reauthorization and FDA reform bill, formally introduced May 15, includes several new provisions, including a moratorium on FDA issuing final guidance on mobile medical apps. The bill should see action on the Senate floor this week.
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