jueves, 14 de diciembre de 2017

CDRH FY 2018 Proposed Guidance Development and Focused Retrospective Review of Final Guidance

In today’s Federal Register, the FDA’s Center for Devices and Radiological Health (CDRH) announced the list of guidance documents that we intend to publish this fiscal year (FY2018).  In addition, we commit to reviewing previously published final guidance documents, updating or deleting guidance documents that no longer represent the Agency’s current thinking on a regulatory issue.  CDRH also is committed to finalize, withdraw, re-open the comment period, or issue replacement draft guidance on the topic for 80 percent of draft guidance documents within 3 years of the close of the comment period and for the remaining 20 percent, within 5 years, as resources permit.

We have posted three lists:
  1. guidance documents that the Agency fully intends to publish (the “A-list”);
  2. guidance documents that the Agency intends to publish as resources permit (the “B-list”); and
  3. final guidance documents that issued in 1978, 1988, 1998, 2008 that are subject to focused retrospective review and for which we appreciate external feedback.
Although resource constraints and new issues that emerge over the course of the year may preclude CDRH from issuing every guidance document on the A-list and B-list and CDRH may issue guidance documents not on the lists, the lists are intended to provide helpful information about CDRH’s current priorities for the upcoming fiscal year.  CDRH plans to update all three lists every year.

We invite you to submit comments on any or all of the guidance document topics to docket FDA-2012-N-1021.  Comments may include feedback on the proposed A and B-list topics, such as suggestions for new or different guidance documents, the relative priority of guidance documents, and/or draft language on the proposed A-list and B-list topics.  Comments may also include suggestions that CDRH revise or withdraw a final guidance document that issued previously, as part of its retrospective review.  If you recommend guidances for revision, please also include an explanation of the need for revision, such as the impact and risk to public health associated with not revising the guidance.  We also welcome any additional feedback for improving the guidance program and the quality of CDRH guidance documents.

Your feedback is critical in shaping CDRH’s guidance development plans.  For additional information, please see:  Federal Register:  Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2018 Proposed Guidance Development.

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