least burdensome provisions FDA draft guidanceThe U.S. Food and Drug Administration (FDA) released a new draft guidance on December 15, 2017 detailing updates to its least burdensome approach to regulation medical devices. The draft follows FDA’s signal that it would move more of the regulatory oversight of devices to the postmarket setting, RAPS reports.

The least burdensome provisions were originally documented in 1997 under the FDA Modernization Act (FDAMA). The provisions were further clarified in the FDA Safety and Innovation Act (FDASIA) and the 21st Century Cures Act, allowing FDA more freedom to leverage postmarket activities to offset risk at the time of premarketing decisions.1

FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren argue that applying least burdensome principles to device review in recent years resulted in a reduction of review times and an increase of higher quality applications from the medical device industry. In a blog post, Gottlieb and Shuren state that “timely patient access to high quality, safe and effective medical devices requires that FDA reduce or reform those outdated, unnecessary burdens in our regulatory approaches that can add to development costs or forestall beneficial innovation without also enhancing device safety and effectiveness.”1,2 They also argue that new systems currently under development by the agency will help mitigate safety issues for devices in pre- and postmarket settings.

Contrasting the 2002 guidance on least burdensome provisions, the new draft guidance focuses on minimizing the amount of information needed to “adequately address a [pre- or postmarket] regulatory question or issue through the most efficient manner at the right time.”1 FDA explains that these least burdensome principles will apply to1:

  • Premarket submissions, including PMAs, premarket notifications (510(k)s, de novo requests, humanitarian device exemption (HDE) applications and investigational device exemption (IDE) applications
  • Additional Information and Major Deficiency letters
  • Q-submissions
  • Informal or interactive inquiries regarding device development
  • Panel review and recommendations
  • Postmarket surveillance and post-approval studies
  • Reclassifications and exemptions
  • Guidance documents and their application
  • Compliance-related interactions
  • Regulation development

Public comments on the draft guidance may be submitted to FDA within 60 days of publication. 2018 is shaping up to be another dynamic year for the medical device regulatory landscape, as FDA is also anticipated to develop guidance next year for a less burdensome “alternative” pathway for 510(k) medical devices.3 Our dedicated team is equipped to help you prepare for the upcoming industry changes. Learn more about how Pearl Pathways guides startup and large medical device companies through the challenges of developing various types of medical devices here.



1 http://www.raps.org/Regulatory-Focus/News/2017/12/14/29057/FDA-Discusses-Device-Least-Burdensome-Provisions-in-New-Draft-Guidance/

2 https://blogs.fda.gov/fdavoice/index.php/2017/12/new-steps-to-facilitate-beneficial-medical-device-innovation/?utm_campaign=FDA%20Voice%20New%20Steps%20to%20Facilitate%20Beneficial%20Medical%20Device%20Innovation&utm_medium=email&utm_source=Eloqua

3 http://www.raps.org/Regulatory-Focus/News/2017/09/27/28556/CDRH-Plots-Creation-of-New-Super-Office-Alternative-510k-Pathway/