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CDRH Learn: The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions

Slide 1 

Hello, my name is Simon Choi. I am a health science analyst in the Standards and Conformity 

Assessment Program at FDA. The title of this presentation is “The ASCA Pilot: Streamlining Conformity 

Assessment in Device Submissions.” In this module, we’ll introduce you to the Accreditation Scheme for 

Conformity Assessment pilot program, or ASCA, as it’s known for short.

Slide 2 

Testing is a critically important part of device development and manufacturing, and of course, a central 

aspect of the FDA’s review processes. Essentially, the ASCA Pilot establishes an accreditation program 

for testing laboratories. Test results from ASCA-accredited test labs should enhance device 

manufacturers’ and product reviewers' confidence in medical device testing. This, in turn, should reduce 

FDA’s need to request additional information regarding testing conducted to support premarket 

evaluation. Ultimately, the ASCA Pilot is designed to enhance FDA’s approach to conformity assessment 

in premarket review.

Slide 3 

We’re going to accomplish three things during this session. First, we’ll talk about the program itself: 

what it is and why it will benefit manufacturers and the FDA. Next, we’ll go over, step by step, how to 

prepare a premarket submission which includes testing from an ASCA-accredited testing lab. Finally, 

we’ll close with some helpful tips on how to participate successfully in the Pilot. Before I begin, I should 

note that we understand that there are different types of organizations that submit their devices for 

FDA review. For the purposes of this module, I will use the word “manufacturers” throughout to refer to 

anyone who files device submissions.

Slide 4

Let’s get started with an introduction to the ASCA Pilot and its benefits.

Slide 5 

The ASCA Pilot was developed with input from experts across the medical device manufacturing and 

conformity assessment communities. It is a voluntary program. It leverages a well-established 

international conformity assessment infrastructure, and it capitalizes on the use of voluntary consensus 

standards in device development and review. We are “putting standards to work’” on both an individual 

submission level as well as on the international level!

Slide 6 

The ASCA Pilot is authorized under section 514(d) of the Federal Food, Drug, and Cosmetic Act and is 

part of the Medical Device User Fee commitments of 2017. The Pilot was built with the intention of 

increasing FDA’s confidence in the test methods and results in device submissions. That enhanced 

confidence means that manufacturers should usually see fewer requests for additional information 

regarding testing methods. This, in turn, helps leads to a review process that is more consistent, 

predictable, and efficient – which supports CDRH’s commitment to a “least burdensome” approach. 

Finally, at the end of the day, ASCA should help the patients we all serve to have access to safe, effective 

and high-quality devices.
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Slide 7 

Before we go any further, I’d like to distinguish between two important terms in the ASCA Pilot. The first 

is ASCA Recognition. ASCA Recognition is a formal status that the FDA grants to accreditation bodies 

who demonstrate the qualifications summarized in the ASCA program guidance. This is not to be 

confused with the FDA’s standards recognition program, though the two are related in that only FDArecognized versions of standards are included in the ASCA Pilot. The second ASCA Pilot term is ASCA 

Accreditation. This is the formal status that the FDA grants to qualified testing laboratories that meet 

ASCA Pilot specifications outlined in the guidance. This is separate from any other accreditation a test 

lab may have from accrediting bodies.

Slide 8 

ASCA is a brand-new voluntary program for the FDA and manufacturers. In fact, it is the first conformity 

assessment initiative of its kind using FDA-recognized standards within CDRH and the first time FDA is 

directly engaging with the conformity assessment community. This slide outlines the pre-ASCA 

environment: FDA’s key interactions were between FDA and industry. Industry worked with test labs, 

and test labs worked with accreditation bodies. Accreditation bodies interacted with ILAC, which is the 

international accreditor of accreditation bodies. Those individual, bilateral relationships are depicted by 

the light blue arrows you see.

Slide 9 

Here you see how the relationships change. The ASCA Pilot introduces new interactions: the FDA is now 

working with both accreditation bodies and testing labs, and you can see those new relationships in the 

dark blue arrows. In the future, we anticipate working with ILAC as well, as noted by the yellow dotted 

arrow. This dynamic community is all coming together to support our shared priorities of improving 

device review and advancing regulatory science.

Slide 10 

Understanding how those individual entities work together as part of the ASCA Pilot makes this slide a 

little easier to understand. I won’t go into too much detail, because I know your interest lies in how 

manufacturers are expected to participate, but the process goes like this. First, FDA grants ASCA 

Recognition to accreditation bodies who meet Pilot specifications. Second, the test labs may apply to 

the FDA for ASCA Accreditation. Both independent and in-house test labs may participate. Third, device 

manufacturers select an ASCA-accredited test lab and develop a test plan. Fourth, the test lab conducts 

testing and sends both the complete test report and a Summary Test Report to the manufacturer. Fifth, 

the manufacturer sends a declaration of conformity and the Summary Test Report to the FDA with its 

device submission. And finally, FDA conducts its review according to the ASCA guidance. We’ll dive into 

how all this works in just a moment, but first a little background.

Slide 11 

Three guidance documents outline the parameters of the ASCA Pilot. The first is a program guidance, 

with general information about the Pilot and how to participate. The other two are standards-specific 

guidances that outline specifications for the two standards families included in the Pilot: 

biocompatibility and basic safety and essential performance. How did we go about choosing which 

standards should be included in the ASCA Pilot? Well, we asked you, and we asked conformity 

assessment experts. We wanted standards and test methods that were both cross-cutting and productspecific, and ones which would yield good insights into how a conformity assessment program should 

work.
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Slide 12 

The biocompatibility scope in the ASCA Pilot includes the standards listed in the left column and the test 

methods in the right column. Be sure to check the biocompatibility standards-specific guidance. There is 

also a button on the ASCA web page called “View ASCA Pilot Standards” that will take you directly to a 

list of ASCA standards in our Recognized Consensus Standards database. This database is also where 

you’ll find the Supplementary Information Sheets. These contain important information about the 

version of the standard, extent of recognition and related guidances you should know. 

Slide 13 

The basic safety and essential performance standards in the ASCA Pilot are from two families: 

ANSI/AAMI 60601-1 and IEC 61010-1. There are too many to list here – the Basic Safety and Essential 

Performance standards-specific guidance and the ASCA web page contain the complete list.

Slide 14 

Now let’s turn our attention to how to go about preparing a premarket submission that contains ASCA 

testing.

Slide 15 

The ASCA aspects of a premarket submission are not complicated and can be summarized in 5 steps. 

Let’s review them one at a time, starting with Step 1.

Slide 16 

This step is straightforward: identify the ASCA Pilot standards to be cited. The important thing about 

this step is that you should first check the list of ASCA Pilot standards, then go to the Recognized 

Consensus Standards database to access and review the Supplementary Information Sheets. Be sure to 

check the extent of recognition – partial or complete – as well as the edition. A quick but important 

reminder: the manufacturer maintains responsibility for the choice of standards and test methods and 

appropriate use and application.

Slide 17

Next up is to develop and agree on a test plan with the ASCA-accredited test lab. 

First, select an ASCA-accredited testing laboratory, and then work together to develop and agree on a 

test plan. Just remember that you, as the manufacturer, are ultimately responsible for the test plan. 

Keep some things in mind as you develop the test plan. Consult relevant FDA guidance documents, and 

not just ASCA Pilot guidances. The standards you use must be the FDA-recognized version of the 

standard – be sure to check the extent of recognition. In cases of partial recognition, the Supplementary 

Information Sheets will have more information on the rationale for a partial recognition and may also 

point you to relevant FDA guidance documents to aid in the development of your test plan. All of this 

information can be found in the Recognized Consensus Standards database. And finally, be sure to check 

that the test laboratory’s scope of accreditation matches the edition or version of the recognized 

standard you’ve chosen to use.

Slide 18 

Step 3 is to plan the submission elements. So, what are the ASCA elements of a premarket submission? 

First is the cover letter of the submission. In the cover letter, you will include a reference to the ASCA 

Pilot so that we can flag it as an ASCA submission. The other elements are the declarations of 

conformity and the Summary Test Reports. We’ll go into greater detail about these in just a moment, 
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but it’s important to remember that complete test reports generally do not need to be included in the 

submission.

Slide 19 

Next, the laboratory will conduct the testing according to the agreed-upon plan, and then send you the 

complete test reports and ASCA Summary Test Reports.

Slide 20 

Step 5 is when it all comes together: you prepare your FDA submission. You’ll prepare your cover letter 

that includes ASCA-specific information, the declarations of conformity, and the Summary Test Reports. 

Of course, as a reminder, do not modify the Summary Test Reports. Submit them just as they were 

received from the testing laboratory. And don’t forget the non-ASCA related components of the 

submission! Other submission requirements are not altered by this pilot.

Slide 21 

Now let’s turn to a deeper discussion of the three ASCA elements you’ll want to include: a cover letter, 

declarations of conformity and the ASCA Summary Test Reports. We’ll review each of these in turn.

Slide 22 

Let’s start with the premarket submission cover letter. This is separate from and in addition to the FDA 

Submission Cover Sheet, or Form 3514. We understand that a cover letter is also commonly included in 

a submission. We encourage inclusion of a cover letter, because this is where you will identify for the 

FDA that the submission is ASCA-related. A reference to ASCA in your cover letter is the way to tell us 

that the submission is ASCA-related. The additional language for the cover letter can be very simple: it 

should clearly state that the submission contains ASCA Summary Test Reports, it should reflect the 

ASCA-accredited test lab’s information, including its ASCA identification number, and it should list the 

ASCA standards and test methods being cited.

Slide 23 

Let’s move on to the declaration of conformity. Remember that this is the manufacturer’s 

responsibility. It should reflect the test lab’s ASCA Accreditation status at the time of testing. We 

encourage you to check out the example declarations of conformity provided in the two standardsspecific guidances.

Slide 24

The third and final element is the ASCA Summary Test Report provided to you by the test lab. We’re 

going to review one in detail in a moment, but as a reminder there are example Summary Test Reports 

in the standards-specific guidances: nine for biocompatibility and one for basic safety and essential 

performance.

Slide 25 

Here are two examples of ASCA declarations of conformity. These examples may be found in the two 

standards-specific guidances.

Slide 26 

The ASCA Summary Test Report examples were developed in response to feedback to the draft ASCA 

guidance. We were asked to offer direction on what a Summary Test Report should contain. Note: these 

are not templates or forms - they are simply advice on what to include. Test labs will likely have their 
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own format for Summary Test Reports. And while you are not allowed to change anything on the 

Summary Test Reports that the test lab sends to you, you as the manufacturer are responsible for its 

contents, so please be sure to check that they contain all the information that FDA expects. 

We’re going to walk through an example Summary Test Report – in this case, from the basic safety and 

essential performance standards-specific guidance. The biocompatibility examples will of course be 

different. The first part addresses three elements. The administrative information, next to the blue 

arrow, provides details about the testing and the lab. It includes a reminder in #5 that the lab should 

have that testing or method in its ASCA Accreditation scope. The red arrow indicates the device essential 

performance characteristics section. It should reflect all those that you as the manufacturer have 

developed. This section should also indicate if there are any differences between the essential 

performance identified in the standard and those essential performance characteristics which were 

considered during the test. The next section, with the green arrow, describes the use environment, 

reflecting where the device is intended to be used.

Slide 27 

In the Clauses Tested section, next to the blue arrow, the test lab goes into detail about how and what it 

did and did not test. The test lab will also want to indicate if any modifications were made to the test 

methods or the acceptance criteria – highlighted there by the red arrow. Recall that some standards 

allow choices; this is how the lab will note those choices. 

The green arrow points out where the test lab would describe any additional testing that was 

performed, along with its results. And at the bottom of this page next to the yellow arrow, you can see 

that we would want to understand how the device was configured, including its mode of operation, 

during all of the testing.

Slide 28 

Finally, we come to the test results section. The test lab is expected to be very clear about any 

”observations and degradations” during the testing, as seen here by the blue arrow. And if they did find 

such observations, they should enter only the unexpected ones. In the next section, the red arrow 

indicates whether the test lab made any modifications to the device. They then describe any identified 

concerns – highlighted by the green arrow - which would have been clearly communicated to the 

manufacturer. And finally, the yellow arrow points to where the test lab signs to confirm that the 

document is accurate and summarizes all original and any retest data. As we mentioned earlier, 

individual test labs may have different styles or formats for their ASCA Summary Test Report. However, 

those reports should still reflect the expected content described here and in the guidance documents.

Slide 29

Let’s close with some tips to help you prepare a successful ASCA submission.

Slide 30

First, ensure that your submission cover letter is complete and that it indicates that it contains ASCA 

Pilot testing. It should provide the name, location and identification numbers of the ASCA-accredited 

test labs you worked with, as well as the FDA-recognized standards and test methods used. This will flag 

the submission so that the FDA reviewer knows to look for an ASCA declaration of conformity and 

Summary Test Report. Include complete declarations of conformity for all cited FDA-recognized 

standards. 
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Submit ASCA Summary Test Reports, as supplied by the testing lab. And finally, but most importantly, 

please don’t hesitate to ask questions. The ASCA Pilot is a new program and we are here to help you in 

any way we can.

Slide 31 

I’d like to recap what we’ve shared here today. The Accreditation Scheme for Conformity Assessment 

Pilot brings together stakeholders from across the device community who contributed to the design of 

the Pilot, which relies upon and leverages international consensus standards. At the same time, these 

stakeholders are helping us advance regulatory science. Our shared goal is to enhance the use of 

conformity assessment in device premarket review.

Slide 32 

ASCA’s advantages are potentially significant, for both manufacturers and the FDA. It is designed to 

increase consistency and predictability in FDA's approach to assessing conformance, which should 

reduce regulatory burden. Most importantly, we expect that the patients we all serve will benefit from 

the ASCA Pilot, as safe and effective devices are made available to them without unnecessary delay.

Slide 33 

We reviewed the five steps to preparing a submission with ASCA testing. These are: identify the ASCA 

standard, agree on a test plan with the ASCA-accredited test lab, plan the submission elements, obtain 

the test results and summary test reports, and prepare the FDA submission. 

And finally, we reviewed the three elements of an ASCA submission: the cover letter with ASCA-specific 

information, the declaration of conformity and the Summary Test Reports.

Slide 34 

The next few slides include resources for you to use after watching this presentation. On this slide, I’ve 

listed the links to the three ASCA Pilot guidance documents we discussed.

Slide 35 

This slide provides some websites that should be helpful to you use standards in your submissions.

Slide 36 

This slide includes two important standards-related guidances: Recognition and Withdrawal of Voluntary 

Consensus Standards and the Appropriate Use of Voluntary Consensus Standards. As a reminder, the 

use of standards is voluntary, and these two guidances represent FDA’s thinking on these important 

standards topics. I’d also like to draw your attention to CDRH Learn, which features a series of 

educational modules on the standards program – these may be found under the “How to Study and 

Market Your Device” section.

Slide 37 

And of course, we urge you to tap into CDRH Learn and Device Advice for additional regulatory 

education. You may also contact D-I-C-E directly by phone or email with any general regulatory 

questions you may have. Useful information is listed on this slide.

Slide 38 

I’d like to close today with your call to action. First, you promote the use of recognized standards in 

device submissions: among your colleagues, within your firms, everywhere. Second, please participate in 
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the Pilot! You have a lot to gain – time, efficiency and the confidence that you are contributing to the 

advancement of regulatory science. Third, contact us with any questions or feedback for the Pilot. 

And because the best, most regulatory-ready standards are ones built by a broad cross-section of 

experts, please get involved in standards development. Your insights and contributions are invaluable 

and will help us at the FDA put standards to work. Thanks for watching!

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