The Food and Drug Administration (FDA) is coming under scrutiny over the long awaited publication of its final guidelines on how it should regulate medical and health apps.

The mHealth Regulatory Coalition last week wrote to HHS Secretary Kathleen Sebelius (pictured), saying the FDA should publish the guidelines “as soon as reasonably possible”.

The agency published its draft guidelines in 2011 but has yet to follow up with its final rules which will have a major impact on the expanding marketplace for a wide range of medical, health and wellness apps.

According to Mobihealthnews, publication is “imminent” but the publication warned that at least one voice is asking for a delay.

The Bipartisan Policy Center is exerting pressure on the HHS. Last week, the group  asked for a delay in FDA publication until an ONC working group, which is developing a framework for health IT regulations, comes up with proposals.