US FDA Proposes Expanding Abbreviated 510(k) Program for Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- US FDA has proposed expanding its Abbreviated 510(k) Program for medical devices utilizing well-understood technologies.
- Expanding the abbreviated premarket notification pathway would provide faster US market access for some devices and streamline FDA review activities.
- FDA plans to issue additional guidance on program criteria in the coming months.
The US Food and Drug Administration seeks to expand its Abbreviated 510(k) premarket review program to meet least burdensome principles and expedite market access for qualifying medical devices.
New draft guidance from the agency would allow qualifying US medical device market registrants to utilize methods such as conformity to FDA-recognized consensus standards, FDA guidance and special controls to show that their products meet all performance characteristics required to support Substantial Equivalence (SE) claims. Currently, the Abbreviated 510(k) Program entails direct comparisons of specific sets of performance criteria between applicants’ devices and predicate devices incorporating technologies or designs that in some cases may be too dissimilar or outdated.
By expanding the Abbreviated 510(k) program, FDA expects to streamline reviews of 510(k) applications and reduce time to market for registrants, as well as establish more transparent criteria for devices cleared through the abbreviated review pathway. Expanding the program also helps the regulator meet Least Burdensome principles for medical device oversight, according to the draft guidance.
Key criteria for the Expanded Abbreviated 510(k) Program
FDA identifies three conditions 510(k) applicants should meet in order to use performance criteria:
- The device’s indications for use and technological components do not differ in terms of safety and effectiveness than that device’s identified predicate.
- The device’s performance criteria match those of at least one legally marketed product of the same device type.
- The device meets the performance criteria in question.
The guidance advises that devices that devices unable to rely wholly on performance criteria required to meet SE requirements do not qualify for the Expanded Abbreviated 510(k) Program, and should undergo Traditional, Special or non-expanded Abbreviated 510(k) review.
Which devices are best suited for the new 510(k) pathway?
FDA plans to provide additional guidance on performance criteria applicable to device types best suited to the expanded abbreviated premarket notification program. Such information will include device product codes, intended uses, indications for use and expectations for technological characteristics.
“Clarifying the set of devices for which the performance criteria are appropriate in guidance and having submitters identify a predicate of the same device type will help ensure that a new device that utilizes this program has (1) the same intended use as, and (2) technological characteristics that do not raise different questions of safety and effectiveness from the predicate device,” states the guidance.
FDA recommends that 510(k) applicants unsure as to whether their devices qualify for the expanded Abbreviated 510(k) pathway utilize the agency’s Q-Submission (Q-Sub) premarket consultation option to discuss with the agency whether their submissions meet the program’s requirements.
How FDA will review Expanded Abbreviated 510(k) submission data
Applicants utilizing the Expanded Abbreviated 510(k) program are expected to provide declarations of conformity and data summaries demonstrating that their devices meet performance criteria identified by the agency.
- A declaration of conformity should be submitted in cases where performance criteria and testing methodologies fall under FDA-recognized standards, and where an applicant has used FDA-specified methods to show that its device meets those performance criteria.
- A summary of data should be submitted in cases where FDA has established performance criteria via guidance and/or special controls, and has specified or recommended testing methodologies.
- Both a declaration of conformity and a summary of data are required when FDA has established performance criteria through guidance and special controls and recommends using testing methodologies from a standard recognized by the agency.
FDA reviewers may also request underlying data in cases where no testing methodologies have been recommended, or where applicants use methodologies other than those identified by the regulator.
Emergo will provide updates to the FDA Extended Abbreviated 510(k) Program as the agency publishes additional guidance and details.