1. 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device Christy Foreman Director Office of Device Evaluation

2. Purpose of this Guidance • First guidance was issued in 1997 (2 drafts before finalizing) • To clarify when a new 510(k) is needed • To ensure consistency between review branches • Original guidance benefits from added clarity in certain sections • Needed to update to reflect new technology • Needed to coordinate with emerging software policies

3. What’s in this guidance? • Basic Principles section that addresses known and potential points of confusion • Nanotechnology note • Manufacturing Changes • Labeling Changes • Technology or Performance Specification Changes • Materials Changes • Changes that Necessitate Clinical Data

4. What’s the same? • Basic logic scheme remains • Same basis in 21 CFR 807.81(a)(3) • Similar introduction and background • Cross-center working group developed based on current understanding of what changes would require new 510(k)s

5. What’s different? • No flowchart, emphasis on use of entire document • similar concept used in PMA modifications guidance • Stressing of certain points: • What the regulation means • Known and potential points of confusion • Brief manufacturing section • More clarity on newer technologies • 1997 has more examples for what does not need 510(k) • 2011 guidance has more examples of what does need a 510(k)

6. Emphases • 807.81: Change requires a new 510(k) when it “could significantly affect safety or effectiveness” • New 510(k) required for changes that could significantly affect • Changes intended as improvements could significantly affect the safety or effectiveness and require a new 510(k) (This concept dates back to the promulgation of the original regulation and was discussed in the preamble) • Known and potential problem points • Based on real world cases, warning letters, etc.

7. Scope of the draft guidance • Doesn’t include devices that don’t require a 510(k) • PMA devices • Class I or II devices that are 510(k)-exempt • Not intended to supersede any device-specific guidances

8. Comments Received • Received 27 official sets of comments, many more unofficial • Still in the process of reviewing • Comments cover the entirety of the guidance, and many echo the points made in the 510(k) Coalition White Paper, although some contradict • Most popular issues: • Flowchart • More examples

9. “Significance” Trigger • “could significantly affect safety or effectiveness” • Intent of guidance is not to de-emphasize “significantly,” but to ensure “could” is recognized as part of the trigger • Whether a change could significantly affect is highly device-specific, so as a horizontal guidance the intent is to provide basic guidelines and questions to consider in determining need for a 510(k) • FDA appreciates that thought process may need more clarity

10. Intended Use • “Major” vs. “could significantly affect” • Safety and effectiveness is bottom line, so FDA does interpret similarly • “Major” is not definable in a succinct statement – Labeling section captures what FDA believes constitute major changes • “Different fashion” – appreciate that this may need additional explanation

11. Clinical Data • Generally, guidance is referring to data that would typically support SE determinations in 510(k)s • Not user preference studies • Based on §B8.2 of ’97 guidance

12. Manufacturing Data • Intent is to capture manufacturing changes that “could significantly affect” • This area in particular is one where manufacturers may have important perspectives • Specific examples of manufacturing changes that could not significantly affect?

13. Special and Abbreviated 510(k)s • Recently-released 510(k) Program draft guidance covers this topic • The modifications guidance does apply equally to changes appropriate for all 510(k) submission types

14. Software • Software issues are highly device-specific, so guidance provides first considerations for deciding whether to submit • Two key considerations: • Could change expand device capabilities? • Could change affect device performance? • Yes to either question may mean that change “could significantly affect”

15. Conclusion • 1997 guidance has been updated with intent to ensure clarity & consistent interpretation by Industry and FDA staff • FDA will issue a second draft prior to finalizing • Pending legislation may impact content of that guidance • FDA appreciates specific examples that illustrate issues