USA – CDRH Offers Look at Upcoming Guidance Documents in FY 2019

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Wednesday published three lists of guidance documents that may be published in the next fiscal year.

The guidance documents are captured in three lists: (1) a list of guidance documents that the agency “fully intends to publish” (known as the « A-list »); (2) a list of guidance documents that the agency intends to publish as resources permit (known as the « B-list »); and (3) a list of final guidance documents issued in 2009, 1999, 1989 and 1979 subject to retrospective review.

Under the A-list, FDA lists the following guidance documents:

Draft Guidance

  • Content of Premarket Submissions for Cybersecurity of Medical Devices of Moderate and Major Level of Concern
  • Surgical Staplers and Staples – Labeling Recommendations
  • Nonbinding Feedback After Certain FDA Inspections of Device Establishments
  • Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
  • Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies
  • Computer Software Assurance for Manufacturing, Operations, and Quality System Software…