November 30, 2021

Volume XI, Number 334


November 29, 2021

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CDRH Posts Planned Guidance Activity for FY 2016

On December 28, 2015, CDRH posted two lists of guidance documents that the Center intends to publish in FY 2016: the “A-list” of draft and final guidance documents that FDA “fully intends to publish,” and the “B-list” of draft and final guidance documents that FDA intends to publish “as resources permit.”  FDA agreed to publish these lists annually as part of the negotiations over the Medical Device User Fee Amendments of 2012.

Notably, the A-list includes finalizing the highly debated draft guidance document “Framework for Regulatory Oversight of Laboratory Developed Tests” issued in October 2014.

Many of the other final guidance documents on the A-list were published in draft last year, including:

  • General Wellness Products (draft published in January 2015)

  • Medical Device Accessories (draft published in January 2015)

  • Adaptive Design for Medical Device Clinical Studies (draft published in May 2015)

  • Incorporating Patient Preferences into Medical Devices Premarket Approvals, Humanitarian Device Exemptions, and De Novo Classifications (draft published in May 2015)

  • Benefit-Risk Factors to Consider when Reviewing IDE submissions (draft published in June 2015)

  • UDI Direct Marking (draft published in June 2015)

The A-list also includes a draft guidance document on 510(k) device modifications.  As we have previously discussed, FDA’s policy on when a new 510(k) must be submitted for a modification to a cleared device has a long history.  FDA’s current policy is described in a 1997 final guidance document.  A revised draft guidance document was issued in 2011 but was required to be withdrawn by section 604 of the Food and Drug Administration Safety and Innovation Act of 2012.  FDA subsequently held a public workshop on the issue in June 2013.

Other draft guidance documents on the A-list include:

  • UDI Convenience Kits (published on January 4, 2016)

  • Public Notification of Emerging Postmarket Medical Device Signals (published on December 31, 2015)

  • Medical Device Decision Support Software (carried-over from the FY 2015 A-list)

  • Software Modifications

  • Companion Diagnostics Co-Development

  • Use of Real-World Observational Patient Data to Support Decision Making for Medical Devices

  • 510(k) Third Party Review Program (currently the subject of a 2001 final guidance document)

The B-List also includes finalizing the 2014 draft guidance document “Reporting of Computational Modeling Studies in Medical Device Submissions” and issuing a draft guidance document on medical device interoperability.

As in previous years, CDRH cautioned that the Center may not be able to issue every guidance document on the A-list and B-list, depending on resource constraints and new issues that emerge over the course of the year.  Indeed, this year’s A-list includes several final guidance documents that were listed in last year’s agenda but have not yet been issued, including:

  • Submission and Review of Sterility Information for Devices Labeled as Sterile (draft published in December 2008)

  • Applying Human Factors & Usability Engineering to Optimize Medical Device Design (draft published in June 2011)

  • Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing (Biocompatibility) (draft published in April 2013)

In addition to the A-list and B-list, CDRH posted a list of final guidance documents that were issued in 2006, 1996, 1986 and 1976 and are subject to a focused retrospective review.  This review comes out of a June 2014 workshop regarding the Center’s development of guidance documents, at which questions were raised regarding how current older final guidances remain.  CDRH resolved to address this concern through a staged review of previously issued final guidances.

Comments on the 2016 guidance agenda or the guidance documents subject to the retrospective review can be submitted to docket FDA-2012-N-1021.  In particular, CDRH asked for comments indicating the relative priority of different guidance topics to interested stakeholders, as the Center intends to consider stakeholder feedback to help prioritize the allocation of resources.  Comments may also include draft language for the A- and B-list guidance documents, suggestions for new or different guidance documents to be included in the lists, and suggestions that CDRH review or withdraw guidance documents listed for the retrospective review.

© 2021 Covington & Burling LLPNational Law Review, Volume VI, Number 7

About this Author

Christina Kuhn, Covington, Food and drug lawyer

Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.

Ms. Kuhn frequently helps multinational device manufacturers as well as start-up device companies navigate the premarket regulatory process, advising companies on regulatory classification, clinical development strategy...