When to Submit a 510(k) for

510(k) Device
Modifications: Deciding
When to Submit a 510(k)
for a Change to an Existing
Christy Foreman
Office of Device Evaluation
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
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
 Materials Changes
 Changes that Necessitate Clinical Data
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
What’s different?
 No flowchart, emphasis on use of entire
 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)
 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.
Scope of the draft guidance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 devicespecific guidances
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
“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
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
 “Different fashion” – appreciate that this
may need additional explanation
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
Manufacturing Data
 Intent is to capture manufacturing changes
that “could significantly affect”
 This area in particular is one where
manufacturers may have important
 Specific examples of manufacturing changes
that could not significantly affect?
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
 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”
 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
 Pending legislation may impact content of
that guidance
 FDA appreciates specific examples that
illustrate issues