FDA Issues Four Final Guidances on 510(k) Medical Device Programs

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The US Food and Drug Administration (“FDA”) recently issued four final guidance documents related to 510(k) medical device programs. The guidance documents relate to the Special 510(k) and Abbreviated 510(k) Programs, as well as the Format for Traditional and Abbreviated 510(k)s, and the Refuse to Accept Policy for 510(k)s. These final guidance documents come as part of the FDA’s push to modernize the 510(k) clearance pathway in an effort to “keep pace with the increasing complexity of rapidly evolving technology.”

The final guidance’s are as follows:

Special 510(k) Program: This guidance identifies an optional pathway for well-defined device modifications for a legally marketed device, where design control procedures produce reliable results that can form the basis of substantial equivalence. The guidance also clarifies the types of changes appropriate for Special 510(k) review, including certain design, labeling and indications for use changes, whether the method to establish the changes are well-established, and whether the results can be reviewed in a summary or risk analysis format.

Abbreviated 510(k) Program: This guidance identifies an optional approach that manufacturers may use to demonstrate substantial equivalence in 510(k)s. FDA review through the Abbreviated pathway involves the use of guidance documents, special controls, and/or voluntary consensus standards. The FDA notes that it believes “that its review of Abbreviated 510(k)s may be more efficient than that of Traditional 510(k) submissions,” and that “by allowing FDA staff to rely on a manufacturer’s summary report on the use of an FDA guidance document(s), special control(s), and/or voluntary consensus standard(s), FDA’s review resources can be used in an efficient manner.”

Format for Traditional and Abbreviated 510(k)s: This guidance describes a general framework of how to format a Traditional or Abbreviated 510(k) submission, but does not provide recommendations for any specific device types, or other types of premarket submissions. The document goes through each of the 20 sections in Traditional or Abbreviated 510(k) submissions, and provides recommendations for the format and content of each section.

Refuse to Accept Policy for 510(k)s: This guidance explains the procedures and criteria the FDA intends to use to assess whether a 510(k) submission “meets a minimum threshold of acceptability and should be accepted for substantive review.” The FDA will review the submission against specific acceptance criteria and inform the submitter within 15 calendar days after submission if the submission is administratively complete, or if not, will identify the missing elements. The guidance contains detailed checklists in its appendices to assist reviewers in determining the acceptability of the submission.

The FDA notes that the 510(k) “framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices,” and further that the “510(k) process allows the FDA to recognize that medical devices exist across a continuum of complexity and risk and that the scope of premarket review should reflect this risk continuum.”

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