CDRH has published a list of guidance documents that the division intends to publish or review in FY2019. There are 3 separate parts to the list:

1. The “A list”, guidance documents that the division intends to publish,
2. The “B list”, guidance that will be published as resources permit, and
3. The Retrospective Review list, selected final guidance issued from 1979-2009 that the division intends to review.

The list is being published to meet certain agreements the FDA made during negotiations with Congress during the Medical Device User Fee Amendments in 2012 and 2017 and the FDA Reauthorization Act of 2017. The publication of the list also triggered a comment period, which ends on 30DEC2018. The division hopes that annual publication of and feedback on these lists will enable companies to be aware of relevant guidance and help the agency improve the overall effectiveness of device guidance.

By the way, CDER’s last guidance schedule was published in January of 2018, so we might expect a new schedule early next year. Here, too is the last CBER guidance schedule – it’s unclear when the next one will be published.

Text Copyright © 2018 Katrina Rogers