AdvaMed is the world’s largest association representing ......Finally, FDA must emphasize that the...

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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Demonstrating Substantial Equivalence Through Performance Criteria; Draft Guidance for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Radiological Health draft guidance Expansion of the Abbreviated 510(k) Program: Demonstrating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 Notice of this draft guidance and request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.

http://www.advamed.org/

Division of Dockets Management (HFA-305) Docket No. FDA-2018-D-1387 July 11, 2018

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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

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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



of 13


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



of 13


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



of 13


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



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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



of 13


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



of 13


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



of 13


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



of 13


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



of 13


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



of 13


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.

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