MEDdesign

510(k) Guidance Shifts Away Substantial Equivalence in Favor of Performance Testing and Criteria

By Jay Mansour
April 11, 2019


• Categories: 03-Manufacturing Execution, 04-Product Design & Development, 05-Quality/Regulatory, Market Access, MEDdesign

On February 1, 2019, FDA issued the Safety and Performance Based Pathway Guidance document, superseding the draft guidance document of April 1, 2018. It applies to CDRH and the Center for Biologics Evaluation and Research (CBER).

This new pathway represents a considerable change for the medical device industry, as it shifts substantial equivalency from testing of predicate devices to well established and robust performance testing criteria and methodologies. It also allows for a less burdensome approach for industry and FDA.

Expanding on the Abbreviated 510(k) Program for demonstrating substantial equivalence for 510(k) premarket submissions, FDA is identifying certain “well understood” medical devices that may be cleared based on performance criteria. The 510(k) submitters of such devices will no longer need to conduct costly testing on predicate devices as part of the detailed substantial equivalency comparative study. Instead, they must comply with the same performance requirements as the predicate devices.

The performance criteria are defined in FDA guidance documents and FDA-recognized consensus standards, as well as special controls (e.g., special labeling requirements).

The key points from this guidance document are listed below:

• The 510(k) submission remains subject to the same RTA (Refuse To Accept) Policy Guidance, and the new device has the same intended use (i.e., the general purpose of the device or its function) as the predicate device.
• The 510(k) submission still includes the same data required for proposed labeling, sterilization, shelf life, biocompatibility, software, electromagnetic compatibility and electrical safety, and performance testing (bench, animal, and/or clinical)
• The 510(k) submission is restricted to a list of eligible devices defined by FDA, pre-defined based on product code, intended use and indications for use
• This new pathway is optional. The same new device may be cleared via traditional, abbreviated or special 510(k) submission, as applicable
• Not all FDA-recognized consensus standards are allowed for use. FDA will publish and maintain guidance documents that defines eligible device, performance standards, detailed testing requirements and special controls. (Changes in such a list would apply only for 510(k)’s that were not submitted yet to FDA)
• According to this new pathway, FDA’s NSE decision (non-substantially equivalent) is issued if the new device does not meet performance criteria
• The new device has indications for use (i.e., the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population) that do not raise different questions of safety and effectiveness
• The new device has technological characteristics that do not raise different questions of safety and effectiveness
• The new device complies with the same performance criteria as specifically defined/updated by FDA for the new device type
• The performance criteria of the new device align with the performance criteria of predicate device
• New device entirely relies on performance criteria to demonstrate safety and performance
• Submitter provides the declarations of conformity, testing protocols and/or related data summaries, based on the performance criteria (recognized standard or FDA-established) as well as on the testing methodology (FDA recognized standard, FDA specified or recommended, or alternative)
• Submitter may choose to use a different testing methodology than recommended by FDA, but needs to provide more testing details
• The substantial equivalence section in the 510(k) submission compares new device to predicate device in terms of indications for use and technology, excluding direct comparison testing
• Third party reviewers are authorized to review such 510(k) submissions

As FDA builds higher confidence in this process, more medical devices may be added to the eligible list. Relying on standards rather than predicate devices shifts the U.S. medical industry closer to the European regulations.
FDA is planning for another major shift, which is to replace 21 CFR 820 with ISO 13485: 2016. A draft guidance document is expected within 2019, and the transition period will likely take few years.

Additionally, FDA recently adopted MDSAP audits to replace FDA inspections (except “For Cause” or “Compliance Follow-up” or PMA-related inspections).

Harmonization of medical device regulations allows the medical device industry to focus on unified set of regulatory requirements to comply with, thus reducing costs and increasing efficiencies. The new 510(k) process is a move in the right direction and is a very important piece of a larger effort.