701 Pennsylvania Avenue, NW Suite 800 Washington, D.C. 20004–2654 Tel: 202 783 8700 Fax: 202 783 8750 www.AdvaMed.org
Bringing innovation to patient care worldwide
July 11, 2018
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket No. FDA-2018-D-1387: Expansion of the Abbreviated 510(k) Program:
Demonstrating Substantial Equivalence Through Performance Criteria; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability
Dear Sir/Madam:
The Advanced Medical Technology Association (AdvaMed) provides these comments in response to
a request regarding the Food and Drug Administration (FDA or “Agency”) Center for Devices and
Radiological Health draft guidance Expansion of the Abbreviated 510(k) Program: Demonstrating
Substantial Equivalence Through Performance Criteria. Notice of this draft guidance and request
for comments were published in Federal Register Vol.83,
No. 71/Thursday, April 12, 2018.
AdvaMed is the world’s largest association representing manufacturers of medical devices,
diagnostic products, and health information systems that are transforming health care through earlier
disease detection, less invasive procedures and more effective treatments. Our members range from
the largest to the smallest medical technology innovators and companies. We welcome the
opportunity to comment on this guidance and look forward to working with FDA to ensure the
revised guidance meets the needs and expectations of both FDA and industry.
We appreciate FDA’s attempt to offer additional opportunities to establish substantial equivalence
through the Expanded Abbreviated 510(k) pathway. The current 510(k) pathways (Traditional,
Special and Abbreviated) have served patients and industry well. Through legislation and changes in
FDA policy, the 510(k) processes have evolved as innovation and technology have changed. FDA
holds companies to high standards by ensuring that new devices meet current safety and performance
expectations. Ethical concern for the safety and well-being of patients motivate companies to
produce devices that meet the highest standards. Good business practices motivate companies to
produce devices that meet their customers’ current needs as well as avoid the substantial penalties
imposed by federal laws (recalls and legal actions) when devices do not comply with the law.
The voluntary Special 510(k) and Abbreviated 510(k) processes provide means for certain devices to
be cleared for marketing with appropriate data submission and FDA review and are made available to
patients in a timely manner. If properly defined and implemented, this new pathway potentially
complements the current 510(k) pathways, all of which assure that patients have timely access to
safe, effective and high-quality medical devices.
Division of Dockets Management (HFA-305) Docket No. FDA-2018-D-1387 July 11, 2018
Page 2 of 13
While we generally support the establishment of the Expanded Abbreviated 510(k) pathway, we have
some concerns. The Expanded Abbreviated 510(k) depends on guidance documents written by FDA
for each device type which will define the performance criteria for each device type. FDA should
provide more information about how it will prepare these guidances. The draft guidance states that
source criteria will come from FDA staff, information in literature, and analyses of data for existing
devices. Absent from the list is input from healthcare professionals and other relevant stakeholders,
including industry, which is typically gathered during the comment period for a draft guidance.
Consulting with healthcare professionals and other stakeholders offers perspectives and expertise
different from sources that FDA proposes to reference. Consequently, to assure that FDA applies all
relevant information, these parties require an opportunity to review and comment on device type
performance criteria.
Preparing many device type guidances will be time-consuming so we encourage FDA to rely heavily
on internationally recognized standards and existing FDA guidances when determining performance
criteria. In some cases, FDA might simply cite standards or guidances in a list on an FDA webpage
rather than preparing new guidance documents. It is important to note that performance criteria
defined by FDA in documents not recognized by other regulatory bodies will not support efforts to
converge global regulatory review requirements.
While we support the intent of this guidance to expand device clearance through conformance to
applicable guidances, special controls, or standards, it is somewhat difficult to determine the impact
of this effort – or to offer more substantive input without better understanding the device types that
will be eligible to use this Expanded pathway. We encourage FDA to share its criteria for
determining the eligibility of device types and to solicit industry suggestions for eligible device
types. FDA might also consider encouraging industry to develop special controls documents to make
more devices eligible for this program.
Finally, FDA must emphasize that the new Expanded Abbreviated 510(k) pathway is voluntary,
applies to certain, well-understood device types, and is an added option to current approaches [e.g.,
Special 510(k), Abbreviated 510(k)] to the Traditional 510(k). The draft guidance states “In
addition, this approach could facilitate healthcare professionals and patients making better informed
decisions by ensuring that a device cleared through this pathway meets a transparent set of
performance criteria.” This implies that a device cleared through the Expanded pathway is somehow
more desirable or safer than devices cleared through current pathways. This is certainly not true. It
is FDA’s responsibility and mandate to assure that all cleared devices – no matter the pathway to that
clearance – are safe and effective. FDA should not represent one pathway as preferable or yielding a
better device than others.
AdvaMed generally supports the establishment of an Expanded Abbreviated 510(k) pathway and
appreciates the opportunity to comment on the draft guidance. We trust that the Agency will
carefully consider our comments (attached) and the concerns highlighted in this letter.
Sincerely,
/s/
Ruey C. Dempsey RAC
Vice President
Technology and Regulatory Affairs
ADVAMED COMMENTS
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
Draft Guidance for Industry and Food and Drug Administration Staff
Page 3 of 13
Line(s) No. – Line number of the guidance Change – Proposed Change to the guidance. Reason – Reason/Rationale for the proposed Change.
Line(s) No. Change Reason
General
List the review clock for the abbreviated 510(k)s that fall within
the scope of this expansion program.
Knowing the number of days that FDA expects to review
submissions that fall within the scope of this program will
allow us, and industry, to better plan out our submission and
marketing strategies.
General
FDA should approach their proposed performance
criteria/standards with global convergence in mind.
FDA-generated performance criteria will be outside the
globally-recognized standards and may not support global
convergence efforts.
General;
101 − 112
An issue will be the clinical (and scientific) evidentiary
standards for validation of equivalent analytical and clinical
performance despite the lack of direct comparisons with the
predicate device, as per the opening paragraphs (lines 101-112).
This issue of evidentiary standards is particularly important
given the cautionary statement regarding those performance
criteria:
“All performance criteria for use of the Expanded Abbreviated
510(k) program will be publicized through FDA guidance
developed for purposes of this program, which may reference
FDA-recognized consensus standards and special controls. If a
device cannot rely entirely on performance criteria identified by
FDA to demonstrate substantial equivalence for its submission,
it is not appropriate for this program.”
ADVAMED COMMENTS
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
Draft Guidance for Industry and Food and Drug Administration Staff
Page 4 of 13
Line(s) No. Change Reason
134
Remove the example and replace it with a more common one. Typically, submitters do not conduct actual testing of
multiple predicate devices. An advantage for submitters is
not having to prepare a comparison to a predicate AND test
to demonstrate performance of the new device.
136 Delete sentence beginning with “Sometimes…” Unnecessary statement.
143 − 145
Remove “In addition, this approach could facilitate healthcare
professionals and patients making better informed decisions by
ensuring that a device cleared through this pathway meets a
transparent set of performance criteria.”
Irrelevant and misleading. This implies that devices that are
cleared through this pathway are “better” than the devices
cleared through the standard pathway. It must be made
clear that FDA considers all 510(k) pathways acceptable
and cleared devices are determined to be safe and effective -
--not better than. The criteria for device performance are
known for every cleared device because they are provided
in the 510(k) summary for the cleared device, in a device
specific guidance and/or an international standard. This
information is publicly available on the FDA 510(k)
website.
ADVAMED COMMENTS
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
Draft Guidance for Industry and Food and Drug Administration Staff
Page 5 of 13
Line(s) No. Change Reason
153 − 154
Remove “or exceeds” from this sentence. The fact that a new device performance exceeds that of the
marketed device is not a factor in determining substantial
equivalence. The performance of the new device must be
substantially equivalent therefore no need for discussing
“exceeds.”
To properly reflect the requirements in the FD&C Act, the
wording “exceeds the performance of” should be removed.
Sections 513(i)(1)(A)(ii)(I) and 513(i)(1)(D) of the FD&C
Act require substantial equivalence, not superior
performance, to a predicate device even though it may be
possible for a newer device to exceed the performance of
the predicate device.
157 Remove “or exceeds” from this sentence. Same reason as above.
164 Remove “or exceeds the performance” from this sentence. Same reason as above.
165
Remove “using equivalent test methodology.” It is difficult if not impossible for applicants to
determine/substantiate equivalent test methodology.
Therefore, this statement lacks clarity and is not in the spirit
of the alternative method. If this term is retained, provide a
reasonable definition of “equivalent test methodology.”
169 − 170 Replace “a Traditional 510(k)” with “a Traditional or Special
510(k) pathway, as appropriate.”
Other 510(k) pathways in addition to Traditional may be
appropriate.
ADVAMED COMMENTS
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
Draft Guidance for Industry and Food and Drug Administration Staff
Page 6 of 13
Line(s) No. Change Reason
176 − 179
Modify wording as follows: “In the optional program described
here, the Expanded Abbreviated 510(k) program, a submitter
would use robust versions of those same mechanisms to
demonstrate all of the alternative performance criteria
established by FDA characteristics necessary to support a
finding of substantial equivalence for a given device type in a
510(k) application where the proposed device has different
technological characteristics than the predicate device.”
As written, the statement suggests that the current
Abbreviated 510(k) program is not robust and does not
require demonstration of all performance characteristics to
establish substantial equivalence. Since it is FDA’s intent
to continue to allow the Non-Expanded Abbreviated 510(k)
as a submission option as stated in lines 188-192 and 236-
238, re-wording this sentence would clarify the intent of the
Expanded Abbreviated 510(k) Program and avoid the
misperception that FDA is allowing companies to market
devices without having to adequately prove substantial
equivalence by meeting all necessary requirements.
The suggested additional wording at the end of the line 179,
“…in a 510(k) application where the proposed device has
different technological characteristics than the predicate
device.” clarifies and reinforces the intent of the Expanded
Abbreviated 510(k) Program as stated in lines 130-132 of
the draft guidance.
ADVAMED COMMENTS
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
Draft Guidance for Industry and Food and Drug Administration Staff
Page 7 of 13
Line(s) No. Change Reason
177;
188 − 190;
255 − 257;
& 353 − 354
Clarify and apply consistently throughout the document when
manufacturers are required to follow all FDA
specified/recommended criteria when available or when data
can be submitted to support testing or methodologies not
specified by FDA.
The draft guidance states submitters must use conformity to
FDA-recognized consensus standards, FDA guidance,
and/or special controls to demonstrate all the performance
characteristics necessary to support a finding of substantial
equivalence for a given device type in Section III. It further
goes on to state if a device cannot rely entirely on
performance criteria identified by FDA to demonstrate
substantial equivalence for its submission, it is not
appropriate for the Expanded Abbreviated 510(k).
However, in Section (III)(C) the draft states that when no
testing methodology is specified or recommended, or when
a submitter chooses to use a testing methodology other
than the methodology specified or recommended,
submitters should submit underlying data to FDA. It is
inconsistent to say that submitters must rely entirely on
criteria identified by FDA and then to suggest a submitter
can choose a methodology other than what is
recommended/specified.
185 − 188
Please provide additional clarification on how the performance
criteria will be made available and easily accessible to the
public. A dedicated page on the FDA website specific to the
Expanded Abbreviated 510(k) program that identifies all
qualifying device types and their performance criteria with links
to the appropriate guidance or reference to the recognized
standard(s) would be helpful.
It is important that the published performance criteria be
easily accessible to companies to ensure the best
opportunity for success of the Expanded Abbreviated
510(k) Program.
ADVAMED COMMENTS
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
Draft Guidance for Industry and Food and Drug Administration Staff
Page 8 of 13
Line(s) No. Change Reason
185 − 188
Replace the sentence beginning on line 185 with
“All performance…” with:
“Performance criteria for use of the Expanded Abbreviated
510(k) program will be found in recognized consensus
standards, special controls or guidance documents for a specific
product type.”
Needing to develop guidance for every device type for this
program is going to be extremely burdensome to the FDA
and will likely limit utility of this program for both the FDA
and industry. Instead, we recommend recognizing
consensus standards completely and relying on third party
certifications.
General
comment with
reference to lines
188 − 192 &
236 − 238
Please clarify and differentiate how FDA intends to distinguish
between and rely on the FDA guidance, which may reference
FDA-recognized standards and special controls that are to be
utilized for the Expanded Abbreviated 510(k) program versus
the Non-Expanded Abbreviated 510(k) program.
Lines 188-192 and lines 236-238 of this draft guidance state
that the Non-Expanded Abbreviated 510(k) option remains
as a submission option available to submitters if the device
cannot rely entirely on the performance criteria identified by
FDA in the Expanded Abbreviated 510(k) program. Since
the Non-Expanded Abbreviated 510(k) submission option
also relies on FDA guidance documents, special controls, or
FDA-recognized consensus standards, it is unclear how the
two programs could still be applicable to the same device
type with two potentially different sets of requirements
(e.g., guidance, special controls, standards) for
demonstrating substantial equivalence. Further, it is unclear
how FDA reviewers will be able to differentiate and enforce
two different sets of requirements for the same device type
via two different submission types.
197 Add “(s)” to the end of “…product code”. Multiple product codes may be appropriate to be addressed
at one time.
ADVAMED COMMENTS
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
Draft Guidance for Industry and Food and Drug Administration Staff
Page 9 of 13
Line(s) No. Change Reason
197 − 198
Remove “and expectations for technological characteristics”. It is unclear what is meant by “expectations” and how FDA
will determine the technological characteristics that are
cited. If FDA has predetermined expectations for certain
technological characteristics, FDA will be driving device
design. This information will be difficult to determine and
require frequent updates. It will reduce utility of the
program and be more burdensome to the FDA by requiring
more frequent updates than otherwise required.
Additionally, it is unclear what will be the outcome of a
device not having the characteristics and/or not meeting the
expectations.
197 Add “and/or” between “uses” and “appropriate indications for
use.”
Editorial because of change described above.
198
Between the sentences on this line, insert:
“FDA may publish lists of the types of devices for which it
believes there is already sufficient information to allow
immediate implementation of the Expanded Abbreviated 510(k)
pathway. Additionally, industry may request FDA to allow the
pathway for products for which there are FDA-recognized
consensus standards through the Q-Submission program.”
Allows FDA to indicate to industry what they believe has
sufficient controls to utilize the program now and allows
industry to suggest additional product categories for which
they believe sufficient controls exist to utilize the program.
ADVAMED COMMENTS
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
Draft Guidance for Industry and Food and Drug Administration Staff
Page 10 of 13
Line(s) No. Change Reason
200
Explain what is meant by “…technological characteristics
prongs of the substantial equivalence analysis.”
More clarity is needed to fully understand FDA
requirements for the submission. The use of “prong” in line
130 and here should be consistent. “Prong” is used in line
130; “prongs” is used in line 200. Perhaps the use of
another word would be helpful and clarify the FDA
intention.
221 − 223
As part of the final guidance, FDA should provide more details
on where specifically the list of device types will be maintained.
Transparency for the process of identifying and maintaining
lists of device types that are eligible for the Expanded
Abbreviated 510(k) program is key.
222 Add “recognized consensus standards, special controls, and/or”
between “the” and “guidance”.
Allow for the possibility that FDA would not have to
prepare a guidance for every device type.
233
Replace “performance” with “safety”. The intent of 510(k)s is to demonstrate that the product is at
least as safe and effective as the predicate device.
Performance of a first device of type might be much greater
than is actually required to accomplish its intended purpose,
and requiring equivalent performance could limit
innovation. Current 510(k) types will still be available for
companies that want to compare performance.
240 − 252 Summarize the use of a declaration of conformity and data
requirements in a table or other easy to comprehend format.
The verbiage is difficult to follow. A table listing the
various scenarios would clarify the requirements.
ADVAMED COMMENTS
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
Draft Guidance for Industry and Food and Drug Administration Staff
Page 11 of 13
Line(s) No. Change Reason
243 − 252
Delete lines 243-252.
Suggest adding “When the performance criteria and testing
methodologies are in an FDA-recognized standard, an FDA
guidance or special control that establishes performance criteria
and recommends or specifies test methodologies, a declaration
of conformity should be sufficient and no additional data is
required.”
When performance criteria are not met and/or specified testing
methodologies are not used, justification and additional data is
required.
It is inconsistent to limit the use of the declaration of
conformity to conformance to FDA-recognized standards.
The use of Declarations of Conformity (DoCs) should
include other FDA-recognized or generated sources. The
essence of the Abbreviated 510(k) is: there are public
criteria, they were met, and we are certifying that this fact is
true.
It is unclear why a manufacturer would need more
information if the test methodology recommended by an
FDA-developed guidance or special controls document
came from an FDA-recognized standard.
FDA has the right to request data summaries and more
information when necessary to assess the safety and
effectiveness of the device. When criteria are not met or
different methodology used, or when there was nothing
specified, that data submission may be necessary. It
remains important to clarify where summary of data and/or
underlying data is required and where it is not.
255 − 257
We would recommend FDA provide an example of when an
Expanded Abbreviated 510(k) could be submitted with no
underlying test methodology specified.
Clarify how an Abbreviated 510(k) program can be used
when no testing methodology is specified, or if the
submitter chooses to use a different testing methodology.
ADVAMED COMMENTS
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
Draft Guidance for Industry and Food and Drug Administration Staff
Page 12 of 13
Line(s) No. Change Reason
265
Remove “in guidance and”. Forcing FDA to publish guidance documents for each
product type is burdensome and will limit utility of this
program.
267 − 272
There should be a mechanism for the sponsor to
suggest/recommend inclusion of device type to the list of
appropriate devices.
Without a mechanism for industry to provide
recommendations, it is unlikely that the full potential of this
program will be realized. For example, there are no special
control guidance documents for IHC devices (and likely
will not be in the future), therefore they will not be eligible
for the Abbreviated 510(k) program. However, if industry
had a mechanism for suggesting special controls (outside of
filing a de novo application) and addition of an existing
device type to the list, there may be an opportunity to
streamline the process of determining substantial
equivalence.
269 − 271
When a device type is removed from the list, discuss the
Agency’s policy and actions on devices that have already been
cleared and are marketed via the Expanded Abbreviated 510(k)
process.
It is important for the Agency to clarify the status of devices
under current review and products already cleared when a
device type is removed or the performance criteria are
altered.
332
Modify the sentence to read: “A declaration of conformity to a
standard, guidance or Special Control.”
Based on previous recommendations on this draft guidance,
declarations of conformance should be acceptable for FDA
guidance and Special Controls.
ADVAMED COMMENTS
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
Draft Guidance for Industry and Food and Drug Administration Staff
Page 13 of 13
Line(s) No. Change Reason
342 − 344 Delete the sentence beginning: “In general…” Submitters should be able to submit a declaration of
conformance for guidance and Special Controls.
343
Revise the sentence to read:
“In general, FDA expects submitters to submit a declaration of
conformity when using standards, guidances and Special
Controls”.
Based on previous recommendations on this draft guidance,
declarations of conformance should be acceptable for FDA
guidance and Special Controls.