Requirements for participating in pilot program: Accreditation Scheme for Conformity Assessment

ASCA Pilot Evaluation Plan- Accreditation
Body and Testing Laboratory Survey
Questions
Contents
I.

Summary ............................................................................................................................................... 2

II.

Background ........................................................................................................................................... 2

III.

Accreditation Body Survey ................................................................................................................ 2

Objectives ................................................................................................................................................. 2
Cohort ....................................................................................................................................................... 2
Questions .................................................................................................................................................. 2
Evaluation Method ................................................................................................................................... 3
IV.

Testing Laboratory Survey ................................................................................................................ 3

Objectives ................................................................................................................................................. 3
Cohort ....................................................................................................................................................... 3
Questions .................................................................................................................................................. 4
Evaluation Method ................................................................................................................................... 5

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I.

Summary

The ASCA Pilot will be evaluated using data analyses with respect to premarket submissions and survey
responses from stakeholders. This document describes the types of survey questions intended for
accreditation bodies and testing laboratories. Survey questions were developed using an approach
similar to that described in the Report to Congress: Least Burdensome Training Audit and using Surveys
101: A Simple Guide to Asking Effective Questions by Stephanie Beadell.

II.

Background

The evaluation of the ASCA Pilot is intended to support commitment D.8.a. in the MDUFA 4
Commitment Letter- “by the end of FY2022: FDA will have piloted and provided a report on the viability
of an ASCA program….”

III.

Accreditation Body Survey

Objectives
-

Objective 1: Determine whether ASCA-recognized accreditation bodies believe the ASCA Pilot is
good idea and worth continuing
Objective 2: Determine the experience that ASCA-recognized accreditation bodies have had with
the ASCA Pilot

Cohort
All accreditation bodies with ASCA Recognition at the time the survey is sent. This cohort includes
accreditation bodies whose ASCA Recognition has been withdrawn.

Questions
The below questions are being asked to determine the effectiveness of the ASCA Pilot. Your input is
important in determining what the ASCA Pilot looks like in the future.
Objective 1: Determine whether ASCA-recognized accreditation bodies believe ASCA Pilot is
good idea and worth continuing
Question
The ASCA Pilot supports international
harmonization by encouraging stakeholders
to utilize consensus standards.
The ASCA Pilot supports conformity
assessment activities
The ASCA Pilot should be continued in
MDUFA 5

Response Options
Agree, Neutral, Disagree
Agree, Neutral, Disagree
Agree- ASCA Pilot should continue as is (write
in box for why)
Agree, With Changes- ASCA Pilot should
continue with some changes (write in box for
changes)
Neutral
Disagree- ASCA Pilot should not continue
even with changes (write in box for why)

2

I would like to participate in the ASCA Pilot if
it continues in MDUFA 5
The ASCA Pilot would benefit from including
additional standards
I believe the following categories of standards
would add value to the ASCA Pilot

Yes, Neutral, No
Agree, Neutral, Disagree
Open Ended (may update to include specific
options as well as open ended response)

Objective 2: Determine experience ASCA-recognized accreditation bodies had with the ASCA
Pilot
Question
Participating in the ASCA Pilot requires as
much work as I expected
I feel confident that if/when I provide
feedback to FDA regarding the ASCA Pilot,
FDA will address my concerns
Information about the ASCA Pilot is easy to
locate
The processes and policies of the ASCA Pilot
are well described
FDA follows the processes and policies of the
ASCA Pilot Guidance document

Response Options
Agree, Neutral, Disagree
Agree, Neutral, Disagree
Agree, Neutral, Disagree
Agree, Neutral, Disagree
Agree, Neutral, Disagree

Evaluation Method
Survey results will indicate the frequency of each response for each question. At a minimum, results will
be provided separately for (a) all respondents, (b) all respondents currently ASCA-recognized, and (c) all
respondents that have ever been withdrawn.

IV.

Testing Laboratory Survey

Objectives
-

Objective 1: Determine whether ASCA-accredited testing laboratories believe the ASCA Pilot is
good idea and worth continuing
Objective 2: Determine the experience that ASCA-accredited testing laboratories have had with
the ASCA Pilot
Objective 3: Determine the extent to which device manufacturers have used an ASCA-accredited
testing laboratory
Objective 4: Determine the perceived impact of the ASCA Pilot on medical device testing

Cohort
All ASCA-accredited testing laboratories at the time the survey is sent. This cohort includes testing
laboratories whose ASCA Accreditation has been suspended or withdrawn.

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Questions
The below questions are being asked to determine the effectiveness of the ASCA Pilot. Your input is
important in determining what the ASCA Pilot looks like in the future.
Objective 1: Determine whether ASCA-accredited testing laboratories believe the ASCA Pilot is
good idea and worth continuing
Question
The ASCA Pilot supports international
harmonization by encouraging stakeholders
to utilize consensus standards.
The ASCA Pilot supports conformity
assessment activities
The ASCA Pilot should be continued in
MDUFA 5

Response Options
Agree, Neutral, Disagree
Agree, Neutral, Disagree
Agree- ASCA Pilot should continue as is (write
in box for why)
Agree, With Changes- ASCA Pilot should
continue with some changes (write in box for
changes)
Neutral
Disagree- ASCA Pilot should not continue
even with changes (write in box for why)
Yes, Neutral, No

I would like to participate in the ASCA Pilot if
it continues in MDUFA 5
The ASCA Pilot would benefit from including
Agree, Neutral, Disagree
additional standards
I believe the following categories of standards Open Ended (may update to include specific
would add value to the ASCA Pilot
options as well as open ended response)

Objective 2: Determine the experience that ASCA-accredited testing laboratories have had with
the ASCA Pilot
Question
Participating in the ASCA Pilot requires as
much work as I expected
I feel confident that if/when I provide
feedback to FDA regarding the ASCA Pilot,
FDA will address my concerns
Information about the ASCA Pilot is easy to
locate
The processes and policies of the ASCA Pilot
are well described
FDA follows the processes and policies of the
ASCA Pilot Guidance document

Response Options
Agree, Neutral, Disagree
Agree, Neutral, Disagree
Agree, Neutral, Disagree
Agree, Neutral, Disagree
Agree, Neutral, Disagree

Objective 3: Determine the extent to which device manufacturers have used an ASCA-accredited
testing laboratory
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Question
To the best of my knowledge, device
manufacturers are aware of ASCA
Accreditation
To the best of my knowledge, device
manufacturers understand what ASCA
Accreditation means
I have conducted testing for a device
manufacturer under the ASCA Pilot
I have conducted testing for the following
number of device manufacturer(s) under the
ASCA Pilot:
I have conducted testing for device
manufactures I did not work with prior to the
ASCA Pilot.
The testing I conducted for a device
manufacturer was included in a premarket
submission to FDA
The testing I conducted for a device
manufacturer was used to meet U.S.
regulatory requirements beyond FDA (e.g.,
OSHA, etc.)
The testing I conducted for a device
manufacturer was used to meet regulatory
requirements of countries and/or
jurisdictions outside the U.S. (e.g., CE Mark)

Response Options
Agree, Neutral, Disagree
Agree, Neutral, Disagree
Yes, No
0
1-5
5-10
>10
Yes, No
Yes, No, Unknown, N/A (I have not
conducted testing for a device manufacturer
under the ASCA Pilot)
Yes, No, Unknown, N/A (I have not
conducted testing for a device manufacturer
under the ASCA Pilot)
Yes, No, Unknown, N/A (I have not
conducted testing for a device manufacturer
under the ASCA Pilot)

Objective 4: Determine the perceived impact of the ASCA Pilot on medical device testing
Question
Device manufacturers consider whether a
testing laboratory has ASCA Accreditation
when selecting a laboratory
Having ASCA Accreditation has improved my
value proposition to device manufacturers

Response Options
Agree, Neutral, Disagree
Agree, Neutral, Disagree

Evaluation Method
Survey results will indicate the frequency of each response for each question. At a minimum, results will
be provided for (a) all respondents, (b) all testing laboratories with ASCA Accreditation at the time of the
survey, (c) all testing laboratories with ASCA Accreditation suspended at the time of the survey, and (d)
all testing laboratories with ASCA Accreditation withdrawn at the time of the survey.

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