FDA Provides Notice to Public of Website Location of CDRH FY 2018 Proposed Guidance Development

On December 12, 2017, FDA issued a Federal Register Notice announcing the website location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH) is intending to publish in Fiscal Year (FY) 2018.  In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders.

FDA CDRH has posted three (3) lists:

  1. a list of guidance documents that the Agency fully intends to publish (the “A” list);
  2. a list of guidance document that the Agency intends to publish as resources permit (the “B” list); and
  3. a list of final guidance documents that issued in 2008, 1998, 1988, and 1978 subject to focused retrospective review.

Note that the “A-list” includes a final guidance on Unique Device Identification: Policy Regarding Compliance Dates of Class I and Unclassified Devices and a draft guidance on Export Certificates.

CDRH Guidance Document Website

Click Here to Open Official Publication