FDA Commits to Modernizing Reviews, Promoting Innovation in 2018

Posted December 13, 2017

The Food and Drug Administration (FDA) says it will step up its efforts to modernize its review process for medical devices, placing a greater emphasis on the use of postmarket data and relying more on international standards to help evaluate products in 2018.

“FDA’s regulatory process has remained largely unchanged since it was first implemented 40 years ago,” FDA Commissioner Scott Gottlieb wrote in a blog post. “As a consequence, there are an increasing number of cases where this basic framework isn’t well-suited to reflect the innovation that we see today in certain technologies and how we must evaluate those technologies.”

Modernizing 510(k) Review

During the first quarter of 2018, the FDA plans to publish draft guidance that will outline a voluntary pathway for demonstrating “substantial equivalence” for devices that would have previously been cleared through the 510(k) pathway. Using the new alternative pathway, manufacturers will be able to demonstrate “substantial equivalence” by meeting safety and performance criteria found in FDA-recognized standards and/or guidance documents.

"This pathway would be available for pre-specified categories of mature devices―those for which safety and performance criteria that meet or exceed the performance of existing, legally marketed devices can be identified," Gottlieb explained. "This approach will also make it easier for FDA to conform its framework for evaluating new products to international consensus standards where such standards exist."

Gottlieb provided the examples of ultrasound imaging machines, common in vitro diagnostic devices, and blood pressure monitors.

Balancing Pre- and Postmarket Requirements

The second draft the FDA intends to publish in early 2018 will detail how the agency decides when it’s appropriate to “place greater reliance on postmarket data” when determining whether the probable benefits of a device outweigh potential safety risks.

“The guidance will outline how certain issues could be ultimately resolved in the postmarket setting, rather than the premarket setting, to allow patients to gain faster access to potentially life-saving devices, when appropriate,” Gottlieb added.

This approach to evaluating uncertainty could be used in any of the existing pathways the FDA uses to clear new devices—510(k), de novo, premarket approval, or humanitarian device exemptions.

Other 2018 Guidance Priorities

Other draft guidance the FDA has prioritized for 2018 will cover these topics:

  • Multifunctional device products: policy and considerations
  • Principles and procedures for the recognition and/or withdrawal of voluntary consensus standards
  • Requests for feedback and meetings for medical device submissions: the Q-Submission Program
  • Validation of automated process equipment software
  • Export certificates
  • The least burdensome provisions: concept and principles
  • The humanitarian device exemption program
  • 510(k) third party review program

The FDA also “fully intends to publish” final guidance focused on:

  • Medical device accessories: describing accessories and classification pathway for new accessory types (revision)
  • Unique device identification: policy regarding compliance dates of Class I and unclassified devices
  • Appropriate use of voluntary consensus standards in premarket submissions for medical devices
  • Considerations for design, development, and analytical validation of next generation sequencing-based in vitro diagnostics intended to aid in the diagnosis of suspected germline diseases
  • Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics

The FDA has published a full list of the guidance the Center for Devices and Radiological Health plans to develop in 2018, including items that will be developed as “resources permit.” Comments on this list can be submitted through www.regulations.gov until Feb. 12.