FDA Issues Four Guidance Documents with Aim to Modernize 510(k) Program

Posted September 17, 2019

The Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) has issued a final guidance document related to the Special 510(k) Program, along with three other final documents describing the Abbreviated 510(k) Program, Format for Traditional and Abbreviated 510(k)s, and the agency's Refuse to Accept Policy for 510(k)s

The four guidance documents "provide consistency, clarity and transparency to industry and the FDA and may conserve resources for both, while still protecting public health, and not altering the statutory criteria for substantial equivalence," according to the FDA, and are part of agency efforts in recent years to modernize the 510(k) premarket clearance process by shifting away from the longstanding practice of comparing new devices to previous iterations, called predicate devices. Previous guidance (i.e., The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications) has been superseded by the Special 510(k) Program guidance and Abbreviated 510(k) Program guidance.

The Special 510(k) Program guidance describes "an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence,” wrote the agency.

Previously, the program was limited to the review of changes that did not affect the device’s intended use or alter the device’s “fundamental scientific technology.” However, the Special 510(k) Program now focuses 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 analysis format.”

The Abbreviated 510(k) Program is another option manufacturers can use to demonstrate substantial equivalence. The voluntary program seeks to conserve agency and industry resources by relying on reports that summarize "the device description, the manufacturer’s device design requirements, risk management information, and a description of test methods used to address performance characteristics."

To facilitate alignment among 510(k) guidance, the FDA also updated two other documents: Format for Traditional and Abbreviated 510(k)s and Refuse to Accept Policy for 510(k)s.

The formatting guidance provides recommendations for each section of a Traditional or Abbreviated 510(k), such as the inclusion of a Medical Device User Fee Cover Sheet (Form FDA 3601), CDRH Premarket Review Submission Cover Sheet (FDA Form 3514), and financial certification and/or disclosure statements for investigators who participated in clinical studies.

The Refuse to Accept (RTA) guidance details the "necessary elements and contents" that CDRH intends to use when determining whether a 510(k) submission can be accepted for substantive review, with the agency stating that it will "inform the submitter within the first 15 calendar days after receipt of the submission if the submission is administratively complete, or if not, to identify the missing element(s)." The guidance includes checklists to assist manufacturers in understanding the information sought by FDA review staff.

Recognizing "that both FDA and industry may need up to 60 days to operationalize the associated updates to the 510(k) RTA guidance" (i.e., until Nov. 13, 2019), the agency said that if a 510(k) is received during that time frame "and does not include all criteria necessary to meet a minimum threshold of acceptability as outlined in the updated RTA guidance, the FDA may decide not to refuse to accept."

The FDA plans to discuss these guidance documents during a webinar on Oct. 31.