The FDA’s device center (CDRH) has established time based performance standards to help ensure draft guidance documents do not remain in an unresolved state for too long. The following draft performance goals have been outlined:
- Draft guidances issued after October 1, 2014: 80 percent will be finalized, withdrawn, replaced or have the comment period reopened within three years
- The remainder or post October 1, 2014 draft documents will be addressed in the same manner with five years
- Draft guidances issues prior to October 1, 2009: 50 percent will be finalized , withdrawn or subject to a reopened comment period in 2015
The performance goals respond to complaints by industry that guidances sit around too long in the draft stage, creating regulatory ambiguity. In June 2014, the CDRH hosted a public forum on the guidance development process where this issue was raised as a primary point of concern. The center agreed and indicated that some changes were needed. The CDRH indicates that it expects to either renew or modify the draft performance goals in fiscal 2016.
On January 8, 2015, the device center issued a notice that highlighted recent upgrades to the CDRH website intended to better distinguish between draft and final guidance. For example, all PDF versions of online draft guidance documents have been updated to with a “DRAFT” watermark.
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