FDA Webinar

Moderator: Irene Aihie

10-22-20/12:00 pm ET

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FDA Webinar: Accreditation Scheme for Conformity Assessment (ASCA) 

Pilot Program - Final Guidances

Moderator: Irene Aihie

October 22, 2020

1:00 pm ET

Coordinator: Welcome and thank you for standing by. At this time, I'd like to inform all 

participants that today's call is being recorded. If you have any objections you 

may disconnect at this time. All participants will remain on a listen-only mode 

throughout the duration of the call until the question answer session. At that 

time, if you would like to ask a question you may do so by pressing star and 1.

I would now like to turn the call over to your host Irene Aihie. You may 

begin.

Irene Aihie: Thank you. Hello and welcome to today’s FDA webinar. I am Irene Aihie, of 

CDRH’s Office of Communication and Education. The FDA issued three final 

guidance documents related to the Accreditation Scheme for Conformity 

Assessment Pilot Program (ASCA Pilot). These guidance documents outline 

the goals and implementation of the voluntary ASCA Pilot, intended to 

increase confidence in testing results from ASCA-accredited testing 

laboratories for certain FDA-recognized standards and help the FDA ensure 

safe, effective, and high-quality medical devices are available to patients 

without unnecessary delay.
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Today Stacy Cho, Senior Policy Analyst for the Standards and Conformity 

Assessment Program here in CDRH, will present an overview of the three 

final guidance documents, with the primary focus of today’s webinar on the 

guidance document titled, “The Accreditation Scheme for Conformity 

Assessment (ASCA) Pilot Program”. She is joined by other Center subject 

matter experts to assist with the Q&A. Following the presentation, we will 

open the line for your questions related to information provided during the 

presentation. 

Now, I give you, Stacy.

Stacy Cho: Hello everyone. Thank you for joining us and thank you Irene for the 

introduction. My name is Stacy Cho and as Irene stated, I will be discussing 

the recently published final guidance, the Accreditation Scheme for 

Conformity Assessment or ASCA Pilot Program.

Next Slide, please. Our agenda for today is to go over the objectives of this 

training session, background information and overview of the ASCA Pilot 

Program. We will discuss the scheme design, the FDA recognized consensus 

standards and test methods selected for the pilot and the roles and 

responsibilities of the different stakeholders, which include the accreditation 

bodies, testing laboratories, device manufacturers and FDA review staff. We 

will conclude with key implementation dates that will be of interest to those 

who want to participate in the pilot.

Next slide. Through today's session, we hope to clearly convey why ASCA 

was developed, understand how ASCA was developed and explain to you 

what ASCA is. This webinar will go over the roles of all stakeholders, 

policies and processes that are specific to each stakeholder and an 

implementation timeline.
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Next slide. The ASCA Pilot is established by statute. During negotiations for 

MDUFA IV, FDA and Industry agreed to establish a conformity assessment 

accreditation scheme for testing laboratories that evaluate medical devices 

according to certain FDA recognized standards. The FDARA amended section 

514 of the Food Drug and Cosmetic Act by adding a new sub-section (in D)

titled Pilot Accreditation Scheme for Conformity Assessment. This is the 

regulatory foundation for the pilot program.

Next slide. While we identify the regulatory foundation of ASCA, I'd like to 

delve further on why the ASCA pilot program was developed. Evidence of 

conformity to one or more FDA recognized standards is often a thorough and 

efficient way for a manufacturer to address certain questions of safety and or 

effectiveness. This is why FDA invests time and personnel into participating 

in various standards working groups so that the agency may have input in the 

development of these different medical standards. For manufacturers and FDA

to benefit from this efficiency, FDA must have confidence in the Declaration 

of Conformity or DOC submitted by device manufacturers in their pre-market 

submission.

This is described in the final guidance document titled “Appropriate Use of 

Voluntary Consensus Standards and Pre-Market Submissions for Medical 

Devices”. While the appropriate use guidance document describes the 

different types of information needed from medical device testing to 

determine safety and or effectiveness in the DOC, in practice, the reliability of 

the determination in the DOC varies depending on the specific laboratory 

performing the testing and the standard being used. 

These differences between testing laboratories and how they conduct the 

testing, in some instances, results in the need for FDA to request additional 
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information and review supplemental documentation given this variability. 

Additional FDA review and questions may lead to repeated or revised testing 

causing delays and or additional costs.

Next slide, please. We establish the why but let us now discuss how the 

program was developed. As mentioned earlier, the concept of the ASCA Pilot 

Program emerged from discussions between device manufacturers and FDA 

resulting in MDUFA IV and FDARA.

FDA then published the Federal Register Notice in May of 2017, requesting 

comments on a set of questions designed to gain insight regarding the 

development and overall design of the ASCA Pilot Program. We then took 

that information and held a public workshop the following year. The 

workshop took place over two days on May 22 and 23 in 2018.

And we invited testing laboratories, accreditation bodies and device 

manufacturers to open discussion across these different stakeholders and 

FDA. Throughout this time and even now, we are collaborating with NIST, 

the National Institute of Standards and Technology to develop the ASCA Pilot 

Program using best practices as established by experts in conformity 

assessment. NIST has helped multiple federal agencies set up conformity 

assessment programs, ranging from OSHA to GSA. We then published the 

draft guidance on September 23 of 2019 and hosted a webinar shortly after. 

We received comments on the draft guidance and have incorporated them into 

the final guidance documents which were published on September 25, 2020.

Next slide. The ASCA Pilot is a conformity assessment scheme in which 

ASCA recognized accreditation bodies will accredit testing laboratories using 

ISO/IEC 17025 and ASCA program specifications.
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For those who may be unfamiliar with the standard, ISO/IEC 17025 specifies 

the general requirements for the competence of testing and calibration 

laboratories. ASCA will then grant eligible accreditation bodies, what we call 

ASCA Recognition. ASCA accredited testing laboratories will conduct 

medical device testing in accordance with ISO/IEC 17025 and the ASCA 

program specifications. ASCA will then grant eligible testing laboratories 

what we call ASCA Accreditation. FDA ASCA staff will administer the 

ASCA program, including managing participation of accreditation bodies and 

testing laboratories, including suspensions and withdrawals.

Next slide, please. The ASCA Pilot Program capitalizes on the relevance of 

consensus standards in device development and regulatory review, as well as 

the existence of a well-established international conformity assessment 

infrastructure. The ASCA Pilot Program aims to improve efficiency of the 

pre-market review process by building confidence in the declaration of 

conformity through the utilization of accredited testing laboratories. 

With this increase in confidence, when device manufacturers include test 

results from an ASCA accredited testing laboratory in a pre-market 

submission, FDA pre-market review staff are expected to generally accept 

declarations of conformity that rely on testing from an ASCA accredited 

testing laboratory without the need for additional questions related to testing 

methodology. FDA has not previously had a relationship with testing 

laboratories, but through the ASCA Pilot Program, we hope to change this by 

opening up a relationship with testing laboratories through accreditation 

bodies.

Next slide. This is a detailed process flowchart that breaks down the previous 

slides in smaller steps. Accreditation bodies that are interested in participating 

in the ASCA pilot apply to FDA for ASCA recognition. FDA grants ASCA 
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recognition to qualified accreditation bodies. Testing laboratories that are 

interested in participating in the ASCA pilot, can receive accreditation from 

ASCA recognized accreditation bodies. FDA will ensure that a list of ASCA 

recognized accreditation bodies will be made available on the FDA website. 

Once laboratories receive accreditation from an ASCA recognized 

accreditation body, they can apply to FDA for ASCA accreditation. FDA will 

grant ASCA accreditation to qualify testing laboratories.

Device manufacturers can then select an ASCA accredited testing laboratory 

from a list posted on FDA’s website for device testing. An ASCA accredited 

testing laboratory conducts device testing and provides information listed in 

relevant ASCA program specifications including ASCA summary test reports 

to the device manufacturer. The device manufacturer includes the DOC with 

ASCA summary test reports in their pre-market submission to FDA. And 

then FDA pre-market review staff applies pre-market review considerations 

per the ASCA pilot.

Next slide. Where is the ASCA pilot described? The draft ASCA pilot 

guidance document was split into three guidance documents for final 

publication on September 25, 2020. The first guidance is the one being 

discussed at today's webinar, which is the overview of the ASCA Pilot 

Program. The following two are standards-specific ASCA pilot guidance 

documents which are also final. 

One is for the basic safety and essential performance of medical electrical 

equipment, medical electrical systems and laboratory medical equipment. The 

second is for the biocompatibility testing of medical devices.
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The standards specific ASCA pilot guidance documents include a list of the 

standards and test methods selected for the ASCA pilot, ASCA program 

specifications for those standards and testing methods, recommended content 

for pre-market submission containing testing from an ASCA accredited 

testing laboratory, example declarations of conformity for those standards and 

test methods and example ASCA summary test reports for those standards and 

test methods.

Next slide. How does the ASCA pilot leverage existing conformity 

assessment resources? FDA did not want to reinvent the wheel. Therefore, 

we maximized the use of existing frameworks and arrangements for the 

ASCA pilot wherever possible. The first framework we leveraged is the 

ILAC MRA, or the International Laboratory Accreditation Cooperation 

Mutual Recognition Agreement. ILAC is an international organization for 

accreditation bodies that are credit conformity assessment bodies, such as 

testing laboratories. Accreditation bodies that are signatories to the ILAC 

MRA are evaluated to ISO/IEC 17011 to demonstrate their competence.

ISO/IEC 17O11 includes specifications for accreditation bodies and is titled 

Conformity Assessment Requirements for Accreditation Bodies Accrediting 

Conformity Assessment Bodies.

Next slide. So how does ASCA leverage the ILAC MRA? Well in the ASCA 

Pilot Program, accreditation bodies must have ILAC MRA signatory status in 

order to qualify for participation. FDA will leverage ILAC MRA policies and 

procedures by reviewing accreditation body peer evaluation reports and or 

participating as an observer during these activities. FDA will also leverage 

17011 policies and procedures by reviewing testing laboratory assessment 

reports and or participating as an observer during these activities.
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Next slide. The second framework that FDA will leverage is ISO/IEC 17025. 

This standard contains specifications for laboratories to operate competently 

and generate valid results. The title of 17025 is General Requirements for the 

Competence of Testing and Calibration Laboratories. Accreditation bodies 

that are signatories to the ILAC MRA already accredit testing laboratories to 

ISO/IEC 17025.

Next slide. In the ASCA pilot, we will leverage this framework by utilizing 

accreditation bodies to use ISO/IEC 17025 plus ASCA program specifications 

outlined in the standard specific guidances to accredit testing laboratories. 

Along the same line, ASCA accredited testing laboratories will conduct 

testing in accordance with ISO/IEC 17025 and ASCA program specifications.

Next slide. So which FDA recognized consensus standards and test methods 

are in the ASCA pilot? In accordance with the MDUFA IV commitment 

letter, the standards and test methods in the ASCA pilot include both crosscutting or horizontal and device specific or vertical standards. They are of

public health significance and have or are able to provide a means for 

establishing acceptance.

The standards are exclusively listed out in each standard specific guidance 

document. In terms of the standards chosen for the pilot program. There are 

no changes from draft guidance to final guidance.

Next slide. For the basic safety and essential performance of medical electrical 

equipment, medical electrical systems and laboratory medical equipment, the

guidance document consists of the IEC 60601/80601 series of standards 

recognized by FDA at the time of final guidance publication. This includes 

IEC 60601-1, ICN US adopted collaterals, along with the particulars.
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Please refer to the basic safety and essential performance final guidance 

document for a complete list of eligible standards.

Next slide. For the biocompatibility testing of medical devices, the following 

is a table of all standards and test methods that are part of the pilot.

Next slide. So how did FDA come up with the ASCA program specifications? 

Well, ISO/IEC 17025 served as the foundation for ASCA program 

specification found in the standard specific ASCA pilot guidance documents. 

The working group that developed the specification consisted of technical 

experts and personnel from FDA and NIST.

To give you a better idea of how this was established, these three images are 

excerpts of Section 7.2 of the ISO/IEC 17025 standard, section 7.2 of the 

ASCA program specifications for the biological evaluation of medical devices 

and section 7.2 of the ASCA program specifications for the basic safety and 

essential performance standards family.

As you can see, the technical experts and personnel for each working group 

went through each section of 17025 and added in additional specifications for 

the two sets of standards that we believe will help bolster the confidence in the 

testing of the selected device standards. This slide shows you how each group 

listed out program specifications for the selection, verification and validation 

of methods.

Next slide. This chart provides a comprehensive overview of how each of the 

different stakeholders relate to one another in terms of their roles and 

responsibilities. I realized that the font size is small but this chart shows the 

various interactions between the stakeholders that provides a great 

visualization of these relationships.
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Accreditation bodies in the green box, they apply to FDA in the blue box for 

ASCA recognition. And then FDA ASCA staff grant ASCA recognition to 

qualified accreditation bodies. The yellow box represents the International 

Laboratory Accreditation Cooperation, where ILAC develops and maintains 

the mutual recognition agreement with the accreditation bodies.

Then the testing laboratory in the pink purple box, show that test labs request 

accreditation from ASCA recognized accreditation bodies, who in turn 

accredit testing labs to ISO/IEC 17025 and ASCA program specifications. 

Testing laboratories then apply to FDA for ASCA accreditation and FDA 

ASCA staff grants ASCA accreditation to qualify testing laboratories.

The next focus is on the device manufacturers in the gray box. They request 

device testing from ASCA accredited testing labs, who in turn conduct testing 

in accordance with their scope of ASCA accreditation. Device manufacturers 

then submit pre-market submissions with testing from ASCA accredited 

testing labs to FDA, who then review and provide a final decision on the premarket submission.

The biggest takeaway from this chart is the fact that FDA has a relationship 

with the accreditation bodies, testing laboratories and device manufacturers.

Next slide. We will now take a deeper dive into the policies and processes for 

accreditation bodies. The role of an ASCA recognized accreditation body is 

to accredit testing laboratories using the specifications of ISO/IEC 17025 and 

ASCA program specifications associated with each FDA recognized 

consensus standard and test method in their scope of ASCA recognition.
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So, what are the qualifications? An accreditation body must have signatory 

status of testing to ISO/IEC 17025 within the ILAC mutual recognition 

agreement. They must be based in the United States and they also must agree 

to the terms of participation.

Next slide. The following slide describes the application process an 

accreditation body must go through to be granted ASCA recognition. An 

accreditation body will draft an application for ASCA recognition consistent 

with Appendix A of the ASCA Pilot Program guidance. The accreditation 

body then submit the application via email to ASC@fda.hhs.gov. FDA 

reviews the application within 60 days, FDA will notify the accreditation body 

of final decision via email, and if applicable, of any issues precluding ASCA 

recognition. 

FDA aims to resolve any issues in an interactive manner during the 60 Day 

Review. And if ASCA recognition is granted, we will update the FDA 

website to include the newly recognized accreditation body, the expiration 

date and scope of ASCA recognition.

If an accreditation body wants to extend its ASCA recognition by adding 

standards or test methods to their scope, then the same process must be 

followed.

Next slide. FDA intends to periodically audit accreditation bodies to ensure 

that they are adequately fulfilling program expectation. We heard your 

comments regarding audits, so we fleshed this out a bit more.

FDA will use a tiered approach with three levels of audits. Level one audits 

will leverage the existing arrangement of ILAC peer evaluation by requesting 

a copy of the most recent ILAC peer re-evaluation report. Such periodic 
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assessments will ensure adherence to program expectations. Level two audits 

will ask for a copy of the most recent ILAC peer re-evaluation report, as in 

level one, but will also participate as an observer during the next scheduled 

ILAC peer re-evaluation. Level two audits will take place when level one is 

insufficient. For example, if there are persistent issues with testing 

laboratories accredited by a particular accreditation body. For level three 

audits, FDA will initiate on site or remote audit of the accreditation body 

outside of the ILAC MRA peer evaluation schedule. This will occur when 

level one and level two audits are insufficient. For example, if there is a 

public health concern regarding the safety of a device.

Next slide. This next slide focuses on withdrawals and this is also in response 

to comments received asking for more information. Withdrawal of ASCA 

recognition cancels the accreditation body’s full scope of ASCA recognition 

and removes them from the ASCA pilot entirely.

So why would it withdraw the appropriate? This will happen when FDA no 

longer has confidence in the accreditation body's ability to adequately fulfill 

its role in the ASCA pilot. For example, violation of law or policies outlined

in the guidance or other standards specific ASCA pilot guidance, failure to 

correct nonconformities, failure to adhere to the signed agreement, if there's 

information materially bearing on safety or effectiveness of a device that 

reasonably relates to the accreditation body, and withdrawal or suspension of 

ASCA accreditation for a testing laboratory that was accredited by the 

accreditation body.

Next slide. FDA will send a withdrawal letter via email to the contact on 

record for the accreditation body. The letter will include reasons for 

withdrawals and if appropriate, how these issues may be addressed in the 

future through new applications to the ASCA pilot program. Accreditation 
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bodies can also voluntarily request to withdraw from the program by emailing 

ASCA@fda.hhs.gov. In either case, FDA then notifies ASCA accredited 

testing laboratories accredited for the ASCA pilot by the now withdrawn 

accreditation body. If an accreditation body wants to participate again, they 

must submit a new application.

Next slide. We will now shift gears to the policies and processes for testing 

laboratories. So, what is their role? ASCA accredited testing laboratories 

perform testing in accordance with the specifications of ISO/IEC 17025 and 

the ASCA program specifications associated with each FDA recognized 

consensus standard and test method in their scope of ASCA accreditation. 

After testing is complete, ASCA accredited testing laboratories provide the 

information listed in the relevant ASCA program specifications including an 

ASCA summary test report to the device manufacturer.

So, what are the qualification? The requested scope of ASCA accreditation 

must be consistent with the scope of accreditation provided by an ASCA 

recognized accreditation body. The testing lab has also agreed to the terms of 

participation in the pilot program.

Next slide. The following slide describes the application process a testing 

laboratory must go through to be granted ASCA accreditation. A testing 

laboratory would draft an application for ASCA accreditation, consistent with 

Appendix B of the ASCA Pilot Program guidance. The testing laboratory 

then submits the application via email to ASCA@fda.hhs.gov. FDA reviews 

the application within 60 days. 

FDA will notify the testing laboratory of the final decision via email, and if 

applicable, of any issues precluded ASCA accreditation. FDA aims to resolve 

any issues in an interactive manner during the 60 Day Review. And if ASCA 
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accreditation is granted, we will update the FDA website to include the newly 

accredited testing laboratory, the expiration date and scope of ASCA 

accreditation. If the testing laboratory wants to extend its accreditation by 

adding standards or test methods to their scope, then the same process must be 

followed.

Next slide. FDA intends to periodically audit testing laboratories to ensure 

that they are adequately fulfilling program expectations. FDA will use a 

tiered approach with three levels of audits similar to the accreditation body 

audit scheme. Level one audits will leverage the existing arrangement of 

assessment by the accreditation body of the testing laboratory, as laid out in 

ISO/IEC 17011. FDA will request a copy of the most recent assessment 

report of the testing laboratory. Such periodic assessments will ensure 

adherence to program expectations.

Level two audits will ask for a copy of the most recent assessment report as in 

level one, but FDA will also participate as an observer during the next 

scheduled assessment of the testing laboratory by the accreditation body. 

Level two audits will take place when level one is insufficient. For example, 

if there are concerning trends in the testing laboratory’s complaint log.

For level three audits, FDA will initiate on site or remote audit of the testing 

laboratory outside of the assessment schedule stablished by the accreditation 

body. This will occur when level one and level two audits are insufficient. 

For example, if there is a public health concern regarding safety or a device.

Next slide. The next several slides will discuss suspension and withdrawals of 

testing laboratories from the pilot program. FDA considers the magnitude of 

issues when determining whether suspension or withdrawal is appropriate. As 
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they must feel confident that such actions are sufficient to maintain 

confidence in the program.

Why would a testing lab be suspended? This will occur when FDA identifies 

potential concerns regarding the testing laboratories ability to adequately 

fulfill its role in the ASCA pilot. For example, if there is an existence of a 

nonconformity, inadequate completion of training or communication with 

FDA, information materially bearing on safety or effectiveness of a device 

that reasonably relates to the testing laboratory, such as a GLP warning letter,

or withdrawal of ASCA recognition from the accreditation body that 

accredited the testing laboratory for the ASCA pilot.

Next slide. FDA will initiate a suspension by sending a letter via email to the 

contact on record for the testing laboratory. A testing laboratory can also 

voluntarily request suspension by submitting an email to ASCA@fda.hhs.gov. 

In either case, FDA will notify the accreditation body that accredited that 

particular testing laboratory for the ASCA pilot. The testing laboratory can 

request the suspension to be listed by sending a response to 

ASCA@fda.hhs.gov addressing the issues and concerns identified.

Next slide. Withdrawal of ASCA accreditation cancels the testing laboratory’s

full scope of ASCA accreditation and removes them from the ASCA pilot 

entirely.

Why would FDA withdraw ASCA accreditation? This will happen when 

FDA no longer has confidence in the testing laboratories ability to adequately 

fulfill its role in the ASCA pilot. For example, violation of law or policies 

outlined in this guidance and other standards specific ASCA pilot guidance, 

failure to correct nonconformity, failure to adhere to signed agreement, 

information materially bearing on safety or effectiveness of a device that 
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reasonably relates to the testing laboratory, or withdrawal of ASCA 

recognition from the accreditation body that accredited the testing laboratory 

for the ASCA pilot.

Next slide. FDA will initiate a withdrawal by sending a withdrawal letter via 

email to the contact on record and include the reasons for withdrawal. In turn, 

the testing laboratory can also voluntarily request to withdraw themselves 

from the ASCA program by sending an email to ASCA@fda.hhs.gov. In 

either case, FDA will notify the accreditation body that accredited that 

particular testing laboratories for the ASCA pilot. If the testing laboratory 

wants to participate in the program again, they must send in an application.

Next slide. We will now focus on policies and processes for device 

manufacturers. Device manufacturers may voluntarily choose to use an 

ASCA accredited testing laboratory to conduct testing included in the premarket submission. A list of ASCA accredited testing laboratories will be 

posted on the ASCA FDA website.

Next slide. The ASCA program does not change the fact that device 

manufacturers are responsible for ensuring that FDA recognized consensus 

standards are selected and used appropriately. Device manufacturers may still 

choose to work with a testing laboratory given their expertise in developing 

the test plan. Considerations for development of a test plan for testing at an 

ASCA accredited testing laboratory include other relevant FDA guidance 

documents, such as device type guidance, scientific area guidance or 

submission type guidance, other FDA recognized consensus standards, such 

as collateral and particular standards for basic safety and essential 

performance, the impact of deviations from FDA recognized consensus 

standard,s and testing outside of testing laboratory scope of ASCA 

accreditation.
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Note that deviations with standards are different from modifications allowed 

by a standard. Deviations from standards are not allowed in ASCA because 

we need a declaration of conformity. Please also note that a device 

manufacturer can always request a Q submission to discuss any details.

Next slide. Device manufacturers are responsible for documenting how the 

testing supports pre-market authorization even when testing is performed at an 

ASCA accredited testing laboratory.

The manufacturer will submit a cover letter that includes the following 

information, clear identification of the term ASCA, name and location of the 

testing laboratory where testing was conducted, the ASCA testing laboratory 

identification number, FDA recognized consensus standards and specific test 

methods used during testing.

The manufacturer will also include a declaration of conformity. This 

declaration of conformity will include information already expected in a 

DOC, plus the ASCA accreditation status of the testing laboratory.

In response to your comments, we have included example DOC in the 

standard specific ASCA pilot guidance documents. Supplemental 

documentation may be necessary. Again, please review the standard specific 

ASCA guidance documents. And also, in response to your comments we 

provided example ASCA Summary Test Reports for you. Note that in some 

situations FDA may need information beyond ASCA Summary Test report. 

This is discussed in detail in the standard specific guidance documents.

Next slide. The following slide provides pre-market considerations for FDA 

staff. The ASCA pilot’s conformity assessment scheme provides FDA 
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increased confidence in the methods used and results reported by ASCA 

accredited testing laboratories when testing is performed within the testing 

laboratory scope of ASCA accreditation. This increase in confidence leads to 

the following FDA review policies. FDA intends to rely on the results from 

ASCA accredit testing laboratories for the purposes of premarket review, 

without the need for additional information related to conformance with the 

standard. FDA does not intend to question the validity of test methods within 

a testing laboratory scope of ASCA accreditation.

Next slide. However, there will be exceptions to these review policies. FDA 

will take a deeper dive in the review process and may ask for additional 

information in the following cases which are: as part of periodic audits, if 

FDA becomes aware of information that would result in suspension or 

withdrawal of the testing laboratories ASCA accreditation, if FDA becomes 

aware of information that will result in withdrawal of the associated 

accreditation bodies ASCA recognition, if FDA becomes aware of 

information materially bearing on the study conduct or quality, or if the 

ASCA summary test report indicates an issue with a testing or device. Please 

note that this list is not exhaustive.

Next slide. What if ASCA accreditation was suspended at the time of testing? 

FDA may then need to review additional information and or ask questions to 

determine whether the test results can be used to support a decision on a premarket submission. Please note that FDA is only concerned with the status at

the time of testing, not the time of pre-market submission receipt or review. 

FDA intends to carefully consider the issues resulting in suspension, as well 

as which FDA recognized consensus standards and test methods were subject 

to the temporary labeling constraints of the suspension.
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Next slide. What if ASCA accreditation was withdrawn at the time of testing? 

FDA will then apply the policies applicable to testing from labs that never 

received ASCA accreditation. FDA intends to carefully consider the nature 

and severity of the reasons for withdrawal of ASCA accreditation when 

determining what if any post market action is needed for closed pre-market 

submission that included testing results from testing laboratories whose 

ASCA accreditation has been withdrawn. 

FDA will suspend the testing laboratories ASCA accreditation when specific 

issues are identified that raise potential concerns with the results from that 

specific laboratory. And FDA will withdraw a testing laboratories ASCA 

accreditation when FDA no longer believes the premarket review benefits of 

the ASCA pilot are appropriate for testing conducted at that testing laboratory.

Next slide. We hope that with teamwork across the four different 

stakeholders, accreditation bodies, testing laboratories, device manufacturers 

and FDA, we will be able to leverage the existing conformity assessment 

framework to all of our advantage for efficient utilization of medical device 

testing.

Next slide. I will now conclude with several important dates and timelines to 

keep in mind. The slide describes key application dates. FDA intends to 

publish a list of ASCA recognized accreditation bodies on November 25, 

2020. Applications received on or before November 4, 2020 will be 

considered for publication on this initial list. Applications received after 

November 4, 2020 will be reviewed in the order received and the list of 

ASCA recognized accreditation bodies will be updated as appropriate. FDA 

intends to publish an initial list of ASCA accredited testing laboratories that 

will be updated throughout the pilot. FDA will update the webpage to include 

the anticipated publication date for the initial list of ASCA accredited testing 
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laboratories and the date by which advocates should receive a testing 

laboratories application in order for the organization to be considered for the 

initial list.

For more information, you can visit the Web site.

The following two slides provide training and Q&A sessions information for 

those who want to participate in the pilot program. Accreditation body 

training session for accreditation body program managers is scheduled on 

October 29, from 1 pm to 5pm. This will focus on the overview of ASCA 

pilot policies and processes for accreditation bodies.

Technical ASCA training sessions for accreditation bodies are scheduled from 

October 30 to November 3 from 1:00 pm to 5:00 pm. These sessions will 

provide detailed instruction on how to use the ASCA program specification 

during the accreditation of testing laboratories for the ASCA pilot.

And again, for more information regarding these sessions, including how to 

sign up, please visit the ASCA website.

Next slide. Testing laboratories will be provided with Q&A sessions. Basic 

safety and essential performance testing Q&A will be held on November 16, 

2020 and biocompatibility testing Q&A will be held on November 23, 2020.

Next slide. The following links are to the 3 final guidance documents, the 

ASCA webpage, the FDA recognized consensus standards database and 

appropriate use guidance document. These are resources that will help you 

understand the ASCA Pilot Program.
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Next slide. This concludes the presentation portion of the webinar. We will 

now take questions over the phone. If you have any questions that we cannot 

get to or if you have questions later down the road regarding the asker pilot 

program, please email us at asca@fda.hhs.gov. For more general questions, 

please submit them (dice) at fda.hhs.gov.

At this time, I'd like to introduce the panel of experts present who will also 

help answer your questions. I'd like to first introduce Captain Scott Colburn.

He is the Director of the Standards and Components Estimate Program at 

CDRH. Next is Amy Phelps. She is a Conformity Assessment expert from 

NIST, the National Institute of Standards and Technology. And last but 

certainly not least, (Erin Cutts), who is a Senior Policy Analyst and team lead 

of the ASCA program.

Thank you.

Irene Aihie: Operator, we will now take questions.

Coordinator: We will now begin our question and answer session. If you would like to ask 

your question, press star 1 from your phone, unmute your line and record your 

first and last name clearly when prompted. If you would like to withdraw 

your question, you can press star 2. Just a moment as we wait for questions to 

queue.

Scott Colburn: Good afternoon, this is Scott Colburn. I first want to thank Stacy for doing 

just an excellent job in conveying a very complex and very long guidance. 

Very hard to distill down three guidance documents into a 40 minute 

presentation. But I feel she did an excellent job.
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For all of our participants are called in. Also thank you for the time and effort 

during a very challenging time in our economy and in our public health crisis 

that we are dealing with. We do want to try to make sure we answer as many 

questions as we can. And as Stacy mentioned, if we're not able to get to your 

question or something comes up, please do try to contact the program using 

the email there.

Do we have any questions currently in the queue right now?

Coordinator: We do. Our first question comes from (Michael Yardsale), your line is now 

open.

(Michael Yardsale): Good morning and thank you very much for the presentation. Actually, to 

an extent it's a two part question. I guess the first part and this would be 

around biocompatibility. So, for many submissions, medical device 

submissions, there is quite a bit more in vivo, in vitro, as well as chemistry 

testing performed over and above what is included in this program.

And so, my question is, what is the advantage of participating when during an 

application review, the FDA would be looking at quite a few other tests that 

are not included within this program? And then I guess my second question, 

if it's possible, is, if you are not participating in this, does anything change 

during the application review process, in terms of review of your test results? 

Is there more scrutiny placed on laboratories that aren't accredited under this 

process? Or is there just less scrutiny versus today?

Thank you very much.

Scott Colburn: All right. Thank you, Michael. So, he started off with the tough one, right? 

I'll do my best & I will admit, I'm not the biocompabiltiy expert. So, if you 
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don't feel we're hitting it right, I would encourage you to also forward that 

question on.

First, yes we realized there are several other methods or standards that a 

manufacturer may be looking to do in developing their test plan to address 

their particular medical device depending on its intended use with the contact, 

duration, et cetera that goes into selection of the types of methods that are

necessary based upon the guidance documents or the standards lead you 

down.

The methods and standards that were selected for the pilot program were done 

intentionally to try to address common test methods that are seen a crossed a 

particular type of medical devices but also apply to others that may also need 

additional testing. And in those cases, you would be kind of doing a little bit 

of a split and how you would propose the delivery of that information.

The guidance documents themselves have very specific ways of supporting 

how you address particular methods that are contained in the ASCA pilot. 

And with that, the coordination with the testing laboratory should you choose 

to use one that's participating or has ASCA recognition in the pilot, would 

work with you to fill out those tests report, summary test reports to support the 

declaration of conformity to those particular methods that are made that that 

you can include in your submission.

If you have additional testing, you would need to follow the relevant either 

biocompatibility guidance and or supplemental for how the appropriate use 

guidance would help direct you using that information to support that in your 

submission.
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To the second part of your question, I'll try to remember but what we are 

doing and why, you know, what we're doing within the ASCA pilot program 

as it relates to engagement with the testing laboratories and specifically to the 

biocompatibility testing laboratories, is we really trying to get behind a 

confidence window here of understanding their competence to the specific 

methods and the biocompatibility area is very specific. FDA has put a lot of 

effort over the years to try to coordinate our expectations for how information 

should be delivered. Based upon the types of tests being done.

ASCA opened up that door for us to coordinate that more now with not just 

how accreditation is being looked at from the ISO/IEC 17025 competencies, 

but also in how that information can be delivered by the testing laboratory to 

the agency. So, we no longer need to read or evaluate that over and over and 

each submission, but rather have confidence on it based upon a point in, you 

know, of understanding when they come in for their ASCA recognition. And 

from that, that lowers the threshold a little bit of what we need to be looking 

for and we can be able to rely on the results of tests rather than how it was 

tested to make a regulatory determination. I hope that helps answer your 

question a little bit.

(Michael Yardsale): Thank you very much.

Coordinator: Our next question comes from (Sarah Plough), your line is now open.

(Sarah Plough): Thank you. My question is related to if you're using a third party reviewer 

for your FDAs 510 k submission. Are there any limitations when you're 

going that route with respect to this program?

Scott Colburn: Good, Stacy.
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(Erin Cutts): So, there are no limitations in terms of using third party review program. It 

would just be ensuring that you adhere to the guidance documents established 

for the third-party program and also for the ASCA guidance as well. So, the 

simple answer to that question is no. No limitations.

(Sarah Plough): Okay, thank you.

(Erin Cutts): You're welcome.

Coordinator: Our next question comes from (Tara), your line is now open. (Tara), we'll 

take your questions, your line is now open. (Tara), would you please check 

your mute button.

Okay, our next question comes from (Mi Salaam), your line is now open.

(Mi Salaam): Thank you very much. I think that was a very good, excellent presentation. 

Good job. My question goes in multiple pools. Is ASCA going to have a 

checklist for the 70 logical. I am an auditor; I am an extensive multi-site. 

And ideally (unintelligible) have their own checklist.

And also, SPC is affiliated with 17025 and industrial Canada is also affiliated 

with 17025 and all these they have their checklist to be followed. My 

question is, is ASCA program going to have their own checklist, 17025? 

Thank you.

Scott Colburn: Thanks very much. That's a that's a good question. So, we're working that 

process through the pilot. So, the first stage of this is working with the 

interested accreditation bodies and we know the accreditation bodies as part of 

that develop their checklists at that underneath their own organization. So, 

they will be managing that for each of their applications & each of their 
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programs as they set that up. And we'll have that as part of their application 

with us to kind of show how they are using their technical assessors and

measuring the competencies to 17025 plus the ASCA specific program 

specifications that are outlined in the guidance documents, dependent upon 

the types of scope that testing laboratory is asked for.

The program itself did not develop or will be delivering specific checklists to 

the ABs. Those will be presented to us, based upon the specifications outlined 

in the guidance. I hope that helps. 

(Mi Salaam): Okay, all right. Thank you.

Coordinator: Our next question comes from (Chris Dodd), your line is now open.

(Chris Dodd): Hi, good morning, everyone. To all the panel, I have a couple of questions. 

The first one is related to the accreditation body training session. So, this 

program for training starting with October 29 to November 3, we are in the 

process of considering submitting our applications to the accreditation body. 

Is there a way that we could attend this training and because the application 

might take a little longer? That's my first question.

And the second question is related to I think this pilot program has to start 

with, it should be in USA. Is it also okay to have an accreditation body or the 

consultants or the test lab can be outside the US? Or is there any constraints 

as such?

Scott Colburn: Thank you very much. This is Scott Colburn again. I'll try to tackle that 

question. And I'll invite other experts if they wish to, of course. 
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If you are working are part of accreditation body or are a technical assessor 

that works for one or more accreditation bodies, you can go ahead and submit 

a request to attend the accreditation body technical assessor training that's 

taking place in about a month. Or, yes, in the next few weeks, I'm sorry. But 

the - and we can try to make sure you can get registered into the appropriate 

sessions. So that that is something that anyone is allowed.

We are asking for accreditation bodies that are interested in applying to be a 

participant in the program and to obtain recognition in that first wave to have 

an application in by November 4, which is just the day after the technical 

assessor training to be a part of that first wave announcement, but there may 

be an opportunity after that for another accreditation body to join the pilot 

later on. And again, I just want to stress this as a pilot program. So, we're 

trying to get a first wave of interested accreditation bodies in.

The need to attend the training that's going to be provided on the 29, 30, and 

2, 3 of November, is not a requirement for application and accreditation 

bodies can submit an application now. But one of the requirements for them 

to be able to conduct assessments or accreditations to testing labs to the 

ASCA program specifications is that their technical assessors need to attend 

relevant training. So, I just want to make sure that is clear.

Regarding the second part of your question, you know, the guidance 

document specifically asked that the - for purposes of the pilot that we use a 

US based accreditation body that has an ILAC MRA. So, the accreditation 

bodies themselves would need to be US based and fit that criteria.

Testing laboratories, however, as long as they are accredited by a participating 

accreditation body, that is meeting the criteria can be from outside of the US 

as long as they're following the criteria that is outlined. And I think the 
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guidance is specific to that. So, there's a limitation on that the same way as 

there is with an accreditation body.

And I'll just kind of open that up for anyone else if there's more to add to that.

(Erin Cutts): Hi Scott, this is (Erin), I was going to add just a little bit about the application 

process. So just to I think this was super clear, I just want to just take 

the risk of being even more clear. We will be making decisions for 

accreditation body applications on a first come first serve basis after that 

initial list. So please just get your application in as soon as you can, noting 

that the November 4, timeline is to be on our initial list. But even if you 

submit on November 5, we'll be looking at that right away. You just might 

not make that first list. We will be looking at them first come first serve and 

updating our Web site as needed throughout the pilot.

(Chris Dodd): Great, thank you. Thank you.

Coordinator: Our next question comes from (Mandy Ambrick), your line is now.

(Mandy Ambrick): Thanks. Thank you very much. I think this is kind of a follow up 

question to one asked earlier. And that is in reference to the accreditation 

program, if it's going to be combined in any way with accreditation programs, 

for example, from CSA and UL, for example, supporting the issuance of an 

NRTL in the US? Thank you.

Scott Colburn: So that's a great question. And this has been something we've been actually 

talking about since the thought of the accreditation scheme for conformity 

assessment, realizing that there are a number of other regulatory jurisdictions 

that have similar areas and conformity assessment.
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This is really, I'll kind of put it in the most simple way, it really it's up to how 

the accreditation body wants to address us. We are really, we are very 

cognizant of how OSHA works within their NRTL program but OSHA has a 

different operating platform and how they kind of act more as the 

accreditation body in their program. But we have been coordinating with 

them as well to kind of make sure that we're addressing similar things because

we are interested in harmonization. And same thing with things like the FCC, 

and so forth. So, one of our goals with this is in coordination with the 

accreditation bodies is making sure that, you know, the program specifications 

clearly communicate across other regulatory programs. So, they can be, you 

know, intertwined into each other in a way and not have to be necessarily 

additive. This is probably something that we will learn a little bit more as we 

go on. And if you're having more questions about that, I definitely would 

encourage you to submit that into the program as well. So, we can go a little 

bit further.

I just asked if there's anyone else on the phone and want to add into that.

No, okay, thank you. Go ahead, next question.

Coordinator: Our next question goes from (Jenin), your line is now open. (Jen), your line is 

now open. And our next question comes from (Victor Kaczynski), your line is 

now open.

(Victor Kaczynski): Okay, good afternoon. So, I believe my question was a partially answer. 

And it was related about what's the requirements for testing laboratories 

located outside the United States? So, my understanding is, if they are 

accredited with appropriate scope by a accreditation body, US base and 

recognized by FDA, that will be sufficient to get recognition for that ASCA 

program. Is that correct?
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Scott Colburn: Yes and thank you for asking a question that you answered. That makes it 

easier.

(Erin Cutts): The only other thing I'd add is that there's two parts to the test lab. Testing 

qualificationsfirst the one you mentioned, making sure you have an 

appropriate scope of accreditation from an ASCA-recognized accredention

body. And the second is the signed agreement that we have in the guidance 

section itself, inside the application. And it just outlines all the things that you 

would agree to do agree to acknowledge as part of your participation in the 

program. So that's another part I wanted to point out.

(Victor Kaczynski): Great, thank you so much.

Coordinator: Our next question comes from (Yan Chen), your line is now open.

(Yan Chen): Thank you. I have a question regarding to the testing lab qualification. Let's 

say if a testing lab received a four eighty three warning letter in the past and 

still in the middle of resolving the issue. Does that disqualify the lab from 

attending the ASCA program?

(Erin Cutts): I can try to take that one, and then others can add in.

So we are doing a lot of training, as you heard about the dates, for our 

accreditation bodies to get trained on the program specifications. And we are 

relying on those accreditation bodies to truly go out there and look at the 

things that we think are important. One of the things that we are asking for 

accreditation bodies to do is to consider other things that -- consider, for 

example, GLP, and bio kind of issues. 
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And, you know, how they would look at that sort of information as they’re

accrediting testing laboratories. So I think it will be important for the 

accreditation bodies, they're the ones that are going to be making the 

accreditation decisions. And in using the ASCA program specifications, I 

think they will be looking at some of the same things that might have been in 

the 483.

Is that, does anyone want to add to that? Or maybe clarify something I was 

unclear about?

Scott Colburn: Yes, I think (Erin) kind of hit it well. You know, I think the easiest thing to 

this, there's always anytime there's a question, I would encourage you to 

contact us if you've received accreditation from an accreditation body that is 

participating in the program was received as a recognition and you want me to 

submit. If there's other things that are dependent upon yourself recognition 

that you think would be, you know, something that needs to be, you know, 

brought out, I know, you could always contact us and we can help walk 

through that as well. We want to be - tried to help make sure we walk through 

some of these educate type questions.

I think the guidance document itself though, does walk through, you know, 

what are the things that need to be necessary to demonstrate that you are, you 

know, someone who is qualified to be a participant, or in this case, receive 

ASCA accreditation. But if there's any kind of question, feel free to contact 

the program, and we can try to walk through that question a little bit more in 

detail.

(Erin Cutts): And I realized I was remiss in not saying another part. So I talked about the 

role of the accreditation bodies. There's also the test lab application stuff and 

in particular, for biocompatibility test labs we'll be looking at the procedures, 
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protocols, those things that are biocompatibility lab is doing. So there's also 

that part of the review that's needed to get granted ASCA accreditation.

(Yan Chen): Thank you very much.

Coordinator: Our next question comes from (Damien), your line is now open.

(Damien): My questions were answered already. Thanks.

Coordinator: Thank you. And our last question come from (Ross), I believe your line is 

now open. (Ross) for question, your line is open, please check your mute 

button. And our next question comes from (Mike McGrew), your line is now 

open.

(Mike McGrew): Good afternoon, folks, again, have echoed the sentiments from the rest of your 

listeners, the great presentation now very informative. My question may be 

more of an outcome of the ASCA pilot program, that is part of it. But I want 

to get it on the table. One of the elements that I experienced being in the GLP 

testing world is we are often audited by GMP testing manufacturing related 

facilities. 

And as such, I think there's a mixture of the relevant systems in some of the 

observations, which leads to a potential muddling of those systems. And so 

I'm wondering if as an outcome of the ASCA accreditation, would this 

preclude the need for manufacturers to audit the laboratories?

Scoot Colburn: Hi (Mike) this is Scott Colburn and good to hear from you. I think there 

might be others that can get a little bit more specific. I don't believe it would 

preclude this. What we're doing when working with the accreditation bodies 

is looking to make sure that there's the appropriate procedures in place for you 
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and how you're addressing GLP and how any types of inspection findings or, 

you know, things have been addressed as part of the oversight and what 

they're taking into consideration. But it should be the same requirements and 

expectations that you're seeing today.

The whole idea of ASCA is not to increase or invent requirements, but to look 

at how the existing requirements are in place, but consistently applied and

communicated across the board, so that way that helps the agency develop 

consistent approaches and how we can evaluate that information. So at that 

point, what we can do is make, how we would hope these would be addressed 

by any lab looking for that scope of accreditation under a specific credibility 

area.

I hope that, does that answer your question? It's not, I might get someone 

else.

(Erin Cutts): I was, if you don't mind Scott, I was going to add something in one of your 

points of communication and making sure we're all on the same page. So 

within FDA, we are coordinating and working with other folks in FDA, who 

perform different roles that might be affected by the ASCA program. So we'll 

be talking with BIMO and the folks who do audits, to understand what they're 

looking for. We'll be talking with pre-market review staff on what they see in 

the submissions that come through to really get into a continuous 

improvement kind of approach for the ASCA program.

So there's going to be some coordination communication amongst the 

individuals that allows sharing.

(Mike McGrew): Sure, actually, from my experience, anyway, I've always received pretty clear 

expectations from the FDA is more than manufacturers that I get very mixed 
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signals from. So it's more of the requirements in the FDA to the 

manufacturers that if they're using an ASCA accredited laboratory, there's no 

need for them to be conducting an audit, especially based on their lens, their 

lens will be different than what the laboratory is operating under.

Scott Colburn: Yes, I make that's a really good question. And I think, you know, really, you 

know, we can't say that the manufacturer shouldn't be doing, it is up to them 

and how they manage their own quality system. And you know, I'm sure you 

understand that, of course, but I think what, you know, what ASCA trying to 

do in assessing laboratories that are qualified to receive the ASCA 

accreditation or have been accredited by the ABs is that the procedures that 

are in place are there to make sure findings are being addressed that, you 

know, you're here at least getting, you know, GLP, you know, addressed and 

so forth, by the manufacturer themselves dependent upon, you know, how 

they're using your test to, you know, get into markets and so forth, may feel 

the need to do something that's additional.

Look for the purposes of ASCA that isn't an expectation that is in our 

guidance right now. If I'm understanding your question correctly.

(Mike McGrew): Yes. And that's what I expected. Thanks Scott.

Coordinator: Yes. Our next question comes from (Sarah), your line is now open.

(Sarah): Yes. Hi, thank you so much for the excellent presentation, I actually have a 

couple of questions. The first is whether the laboratory accreditation is 

specific to a specific lab location, or whether a laboratory that's part of a larger 

organization whether an accreditation could be issued to the larger 

organization that has multiple labs in the US or overseas.
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And then my second question is, if you could speak to the process for adding 

other standards to the ASCA pilot program, please?

(Erin Cutts): Sure, understand, I can take a first stab at that and other folks can add in. So 

your first question about accreditation to specific test lab locations, we do

need to have an application for each location of the test lab. So it will be 

location dependent. And you can combine that in one application. If that 

makes sense. We just need to know exactly what scope is being requested for 

the different locations. And then if there are procedures and that sort of like 

differences, especially for biocompatibility, we would need to know the what 

applies to which location, that sort of thing.

Hopefully answers your first question. And then your second question about 

expanding to include additional standards. The ASCA program is a pilot 

program from the MDUFA and in FDARA and it's set to sunset, October 1, 

2022. 

And after that, after its sunsets, you won't be it won't be a pilot anymore. We 

won't necessarily have a program -- we're actually in the middle of negotiation 

discussions to understand what the ASCA pilot program would look like 

afterwards. So during this current phase - so we're in a pilot phase, we were 

not intending to include additional standards right away. We want to learn 

from our experience here first. And we also want to get input from 

stakeholders like yourself, if we did add additional standards.

And yes, I think that answers your question. Did I miss anything, folks? 

Anything to add to that?
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Scott Colburn: Erin was very well put I, I'll just kind of add that, you know, every negotiation 

phase, because we're looking into the next stage of negotiations. And as Erin 

mentioned, we are interested in seeing how the pilot itself runs. And of 

course, we're always looking, you know, from our side of this, as you know, 

what would a permanent program look like? And one of those questions that 

we do consider is, what other types of standards would be

appropriate for such a type of program, of course, we have our recognition 

program that we've had in place since 1997, which permits the manufacturer 

to submit a declaration of conformity. But we have 1400 standards in that 

program right now. And we don't feel that 1400 standards is where we need 

to go with ASCA either.

But we are interested to learn from stakeholders in areas where they feel that 

this type of conformity assessment platform, a third party, so to speak, 

conformity assessment platform, add benefit and value to everything that 

we're trying to do with the objectives here. Have we spurred in some 

framework and proving the overall quality of submissions and testing being 

conducted. 

So there will be times to have discussions on this, but to Erin’s point, at this 

time, we're not intending to open up doors for a lot of different platforms for 

new types of standards to ASCA pilot right now, you know, we're still trying 

to grasp our hands around just getting the first stage going.

Once that gets going and learn more about our program, we'll probably be 

able to have other discussions later on how an approach like that could look. 

What we are most interested in is hearing from our external stakeholders on 

what that could look like to be of highest value for all the stakeholders that are 
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involved in this because it does require all of us to work together to 

understand best practices moving forward.

(Sarah): Great, thank you. Yes, that's perfect. Perfect, perfectly answered my 

questions. Thank you.

Coordinator: Our next question comes from (Dan Schofield), your line is now open.

(Dan Scofield): Thank you for the presentation was very good. My question is, so I'm part of 

a medical device manufacturer. And as a part of that organization, we have an

accredited test labs in there that the test to the IEC 601 of particular in the 

collateral standards. My question is what is the benefit to us of going into this 

type of a program? For instance, I mean, will it shorten our 510 K approval 

cycle time from 90 days to something less than that? Because I haven't seen 

any questions from the FDA, when they're doing reviewing our 510 Ks 

concerning safety or EMC, for that matter? is a part of that, so.

Scott Colburn: That's a great question. And that's a common one we get from the 

manufacturer or stakeholder is, will this reduce my time to market I asked, 

you know, the use of standards and the review of testing from standards is a 

component of review. And so the ASCA program itself does not have as, a 

primary objective to reduce the 90 day time clock for 510(k)'s. But what we 

are very interested in is reducing the types of the additional information 

questions that would put a submission on hold. And, you know, in areas 

where if we had better understanding or a better appreciation or higher 

confidence in how testing is conducted to areas, then we feel we are 

addressing the larger question, which is that total time to market and reduction 

in burden both from the regulatory side but on our review staff, as well as 

manufacturers who have to go back and look at how testing is done, do they 

need to retest? Do they need to deliver testing from a different format?
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So really, the benefit should be having a greater assurance that there's some 

predictability, that we wouldn't be looking to ask questions on how you are 

tested, we're going to be able to see the results of tests based upon the 

summary test report that is in the outlined in our guidance documents. To 

help better illustrate how the information that is contained and how you 

address say basic safety and central performance areas of the standard per

60601 and how that can easily translate to support to your intended use and 

other aspects that are important to the reviewer. 

You know, every manufacturer has a different experience. And I think part of 

that is because we see a lot of differentiation and how the information is 

conveyed in a submission. And, you know, so I can't give a specific answer to 

your particular, you know, precedents on how you've gone through with 

premarket submissions. 

But we do feel that based upon what we have heard, both from our 

stakeholders externally and from many interviews with review staff, that the 

areas that we brought into the pilot are the ones that are most commonly seen 

with additional information questions and add the highest burden to review 

staff in terms of having to submit consultations and do a lot of review work 

where we can lower that burden and have a hopefully a shorter review time 

cycle going on.

I hope that kind of paints that picture a little bit better for you.

(Dan Scofield): Okay, thank you very much.
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Coordinator: Next question comes from (Amanda MacDonald), your line is now open. 

(Amanda MacDonald), your line is open, please check your mute button.

(Amanda MacDonald): Hi, thank you. I have two questions related to the accreditation (body). 

The first is under the appendix for the application under the signed agreement, 

one of the things we have to agree to is to provide ASCA pilot accreditation 

documentation to the FDA upon request. And could you just elaborate exactly 

what's covered under that? Would it be specific testing laboratories records 

that we accredit that you would be looking to see? Or could you just elaborate 

a little bit more about that?

And then my second question is, are remote assessments of the testing labs 

going to be accepted for the program?

(Stacy Cho): So I'll take a stab at those questions. The first one in terms of what's requested 

in that, in the description of accreditation services offered, this would pretty 

much just be kind of an overview of how the accreditation policies and 

procedures that you currently provide, or you have to be described. 

And this would include whatever documents that the accreditation body 

deems necessary, for example, checklists or SOPs, work instructions. We 

didn't want to be limiting in terms of detailing out exactly what type of 

documentation are needed, but rather, in general, making sure that the 

documents provided do support an overarching understanding of the 

accreditation services provided, whether they're the existing accreditation 

services that a body might be conducting right now or kind of how it's tailored 

towards the ASCA program.

So I know that that's a very vague response to your question, because you 

probably wanted something a little bit more specific, but in terms of what it is 
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that we're going to be reviewing, I think it's more along the lines of does the 

content substantiate, you know, confidence and understanding the 

accreditation body and what it provides. So that can come in different shapes 

and forms. We don't want to be overly limiting. But that’s the overarching 

kind of gist of the documents we'd like to look at. 

In terms of your second question. Remote is definitely acceptable, given the 

climate now, you know, this was something that people were doing prior to 

the pandemic, but of course right now, we'd like to state that remote is 

definitely acceptable.

I hope that answers your question. If not, please let me know.

(Amanda MacDonald): Thank you.

Coordinator: And that is it for the question. But now I kind of fall back over your host Irene 

Aihie.

Irene Aihie: Thank you. This is Irene Aihie. We appreciate your participation and 

thoughtful questions.

Today's presentation and transcripts will be made available on the 

CDRHLearn)web page at www.fda.gov/training/cdrhlearn by Friday, October 

30th. If you have additional questions about today's presentation, please use 

the contact information provided at the end of the slide presentation. As 

always, we appreciate your feedback.

Following the conclusion of today's live webinar, please complete a short 13 

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FDA Webinar

Moderator: Irene Aihie

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be found at www.fda.gov/cdrhwebinars immediately following the conclusion 

of today's live webinar.

Again, it works for participating. This concludes today's webinar.

Scott Colburn: Thank you, everybody.

Coordinator: Thank you for your participation in today's conference. All parties may 

disconnect at this time. Leaders, please stand by.

END