FDA Discusses Device Least Burdensome Provisions in New Draft Guidance

Regulatory NewsRegulatory News
| 14 December 2017 | By Michael Mezher 

After signaling that it would shift more of the regulatory oversight of medical devices to the postmarket setting, the US Food and Drug Administration (FDA) on Thursday issued a new draft guidance detailing updates to its least burdensome approach to regulating devices.

FDA's least burdensome provisions were first introduced under the FDA Modernization Act (FDAMA) in 1997, and since then, both the FDA Safety and Innovation Act (FDASIA) and the 21st Century Cures Act further clarified those provisions and gave the agency more leeway to leverage postmarket activities to offset risk at the time of premarketing decisions.

"Timely patient access to high quality, safe and effective medical devices requires that FDA reduce or reform those outdated, unnecessary burdens in our regulatory approaches that can add to development costs or forestall beneficial innovation without also enhancing device safety and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," write FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren.

Gottlieb and Shuren say that applying least burdensome principles to device review in recent years has led to a reduction in review times and higher quality applications from industry. The two also argue that new systems the agency is developing, such as the National Evaluation System for health Technology (NEST), will help to mitigate safety issues for devices in the pre- and postmarket setting.

In September, Shuren announced plans to develop a less burdensome "alternative" pathway for 510(k) devices, which FDA said it would be developing guidance for in 2018. Gottlieb also took to FDA's blog earlier this week to detail some of the agency's upcoming efforts to speed the regulatory process for devices.

Draft Guidance

Once finalized, the new guidance will replace FDA's 2002 guidance detailing the concepts and principles of the least burdensome provisions laid out in FDAMA to reflect the changes made in FDASIA and Cures.

In a shift from the earlier guidance, which defined "least burdensome" as "a successful means of addressing a premarket issue that involves the most appropriate investment of time, effort and resources on the part of industry and FDA," the new 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."

According to FDA, these least burdensome principles will apply to:

  • 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

In terms of reducing the amount of information required from manufacturers, the guidance provides examples companies can leverage less-burdensome sources of clinical data, such as real world evidence and existing data; nonclinical data from bench testing and computer modeling; and alternative approaches to address regulatory and scientific issues.

The guidance also provides examples of how device makers can gather clinical data more efficiently and describes how the agency plans to streamline various regulatory and administrative burdens.

And the guidance details the various ways the agency intends to shift the balance of pre- and postmarket information. Here, FDA points to its recently finalized guidance on when to submit a 510(k) for a change to an existing device and says that its staff should take a total product lifecycle approach to requesting information from manufacturers.

"When requesting information, FDA should assess the right time for obtaining necessary information and determine whether a shift from premarket to postmarket evaluation is appropriate while still reasonably assuring device safety and effectiveness," FDA writes, noting that post-approval studies, postmarket surveillance and medical device reporting can be used when weighing whether or not a device should be marketed.

Guidance, Federal Register Notice


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