Medical Mobile App Draft Guidance Reaches 2nd Birthday

On July 21, 2011 the FDA released its “Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Application.” We have discussed this draft and mobile apps generally here, here, and here. As with all draft guidance documents, following the release of the draft the FDA is supposed to receive and review comments (reported to be about 130), and then issue a revised draft, a final guidance document, withdraw the draft, or do none of these for an extended period, just letting the draft sit. The latter appears to be the  fate of many drafts. The two years that this draft has been out probably qualifies as an extended period. However the FDA did tell Congress, and the public, that the guidance would be released by the end of this fiscal year. Outsiders cannot tell if the appropriate FDA people are hard at work on this item, or if they are distracted in part by other issues. The FDA’s claimed devotion to transparency does not include being able to see how such things are progressing. Once finalized, the guidance document will provide the FDA’s “current thinking” on the subject, but it does not (or should not) officially create any new regulations since new regulations require actual rulemaking. Thus a guidance document is the FDA’s interpretation of the current law and regulations, but is not itself a regulation. In fact guidance documents include the proviso that alternative approaches can be used if they sat...
Source: Medical Connectivity Consulting - Category: Technology Consultants Authors: Tags: Standards & Regulatory Source Type: blogs