The New US FDA 510(k) Performance Criteria, Predicate Device Policy Changes

January 20, 2019

Unperturbed advancements in science and technology prompted the Food & Drug Administration (FDA) to propose updates to the Special 510(k) Program. This new guidance document establishes a scientific and rational pathway for a 510(k) clearance.

Specifically, the agency is proposing to evaluate whether design and labeling changes (including changes to the indications for use) can be reviewed under a Special 510(k) by focusing on whether the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk-based analysis format.

Each of the three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated presents a different challenge. The Special and Abbreviated 510(k) methods were developed under the “New 510(k) Paradigm” to help streamline the 510(k) review process.

Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807, as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls.

The “Special 510(k): Device Modification” utilizes the design control requirement of the Quality System Regulation (21 CFR 820) and may be submitted for a modification to a device that has been cleared under the 510(k) process. The Special 510(k) allows device manufacturers to declare conformance to design controls without providing the data. While the basic content requirements of the 510(k) (21 CFR 807.87) remain the same, this type of submission should also reference the cleared 510(k) number and contain a “Declaration of Conformity” with design control requirements. Manufacturers of Class I devices requiring 510(k) may elect to comply with the design control provision of the QS regulation and submit Special 510(k)s.

Manufacturers of pre-amendments devices may also submit Special 510(k)s. When the legally marketed (unmodified) device is a pre-amendments device, the submitter should clearly state that the device is a pre-amendments device, is legally marketed, and has not been the subject of Premarket Notification 510(k) clearance. Submitters are also required to maintain this information in their files.

What Does This “New 510(k) Pathway” Mean to Medical Device Manufacturers?

  • Qualifying device manufacturers would be able to utilize performance criteria identified and approved by FDA to demonstrate Substantial Equivalence by virtue of device type.
  • The Safety and Performance Pathway approach to substantial equivalence is derived from FDA’s Abbreviated 510(k) Program, in which applicants demonstrate conformity to agency-recognized consensus standards, regulatory guidance or special controls in order to support their substantial equivalence claims.

Safety and Performance Criteria for Product Registration

FDA has identified three requirements that device manufacturers and product registrants must meet in order to demonstrate performance criteria to substantial equivalence:

  • Submitted device’s indications for use and technological characteristics do not raise safety and effectiveness questions that differ from predicate device characteristics;
  • Performance criteria adequately relate to the performance of at least one legally marketed device of the same type as the submitted device;
  • Submitted device meets all performance criteria.

Eligible Device Types

Demonstrating Substantial Equivalence for:

  • Class II devices
  • Class III devices reclassified as Class II
  • Class III devices, as a condition for premarket approval, must reduce or eliminate associated risks.

A Streamlined Regulatory Review Process

More Transparent Predicate Device Policies

An Improved Time to Market

With our extensive expertise across key therapeutic areas in delivering actionable expertise on innovative science that drives businesses and organizations in healing diseases, Nopras is positioned to be a “go-to” resource from device conception through development to post-market surveillance.

Our accomplished scientific and senior technical staff of industry-proven professionals possess decades’ worth of medical research and development and compliance expertise, are not only a great source for insightful, up-to-the-minute medical research and compliance expertise, but a veritable resource for information, analysis and data on the medical device development paradigm.


Call Nopras Technologies to discuss your medical device registration and other compliance needs.

Carla Glaze
Director, Business Development, Strategic Accounts
Phone: 248-341-3845

About Nopras Technologies, Inc.

Nopras Technologies has worked with clients globally in creating value to solve most difficult technical, quality, regulatory and compliance problems to advance new and existing medicines that improve human health. This success is based on our consultants’ abilities to provide industry expertise covering a wide range of technical disciplines, grown from a solid base of scientific and engineering fundamental understanding.

The company provides a broad spectrum of Regulatory, Compliance and Quality Services, Operational Improvement and Technical Services, Turnkey Solutions Services (Facility Start-Up and New Product Launch).

Its service portfolio covers FDA and foreign regulations/ guidelines and spans the full product development life cycle; from clinical development through market scrutiny.

The firm’s staff consists of well-credentialed physicians, scientists, engineers, and technical experts from industry leaders with extensive business and industry experience; many of whom are key opinion leaders, have held key management positions and have earned advanced degrees in medicine, science, engineering and business operate as a working team to integrate the different skill sets they offer.

Nopras Technologies assists clients’ advance promising drug candidates from conception through commercialization by providing technical, quality and regulatory support, assisting in process development and optimization, and manufacturing clinical-trial quantities of drug candidates and regulatory submissions.

The company is based in Novi, MI with offices in Fort Washington, PA, Shanghai, China and Singapore. For more information, visit

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