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Global Medical Device Regulatory Strategy
(SMS), is responsible for coordinating all
CDRH consensus standards’ activities within
its assigned technical area with relevant SDOs.
The recognition process begins when an STG
identifies an existing and needed standard
within its technical area and prioritizes required
activities per common criteria. Then, the STG
coordinates an assessment of whether the stan-
dard can be used to meet a particular premarket
or statutory requirement. Upon completing the
assessment, it then recommends the standard be
recognized, as whole or a part, through publica-
tion in the Federal Register. The Federal Register
notice includes not only the newly recognized
standards it also includes modification to the
previously recognized standard and identifies
any previously recognized standard(s) that no
longer will be recognized. Any medical device
industry stakeholder may propose a standard for
recognition. The process includes submitting the
standard title, reference number, date and SDO.
In addition, the stakeholder must list device
types to which the standard would apply and
a brief identification of device testing, perfor-
mance and/or other characteristics a declaration
of conformity to that standard would address.
In September 2018, FDA finalized the
guidance, Appropriate Use of Voluntary Consensus
Standards in Premarket Submissions for Medical
Devices.24 This final guidance provides guidance to
industry and FDA staff about the appropriate use
of national and international voluntary consensus
standards in the preparation and evaluation of
premarket submissions for medical devices.
In accordance with amendments made
to Section 514 of the Federal Food, Drug and
Cosmetic Act by the FDA Reauthorization Act
of 2017, and as part of the enactment of the
Medical Device User Fee Amendments of 2017,
FDA intends to implement a pilot conformity
assessment initiative, entitled the Accreditation
Scheme for Conformity Assessment (ASCA).
This voluntary, pilot program is designed to
increase consistency and predictability in
FDA’s approach to assessing conformance with
ASCA-eligible standards in medical device
premarket reviews.
The ASCA pilot is intended to reduce reg-
ulatory burden by enhancing product reviewers’
confidence in medical device testing, which
should decrease the need for internal FDA
consultations, complete test report reviews and
additional information requests for standards
that are part of the pilot program. Ultimately, the
ASCA pilot is intended to help FDA ensure safe,
effective and high-quality medical devices are
available to patients without avoidable delay.25
The ASCA guidance document is expected to be
finalized in late 2020 or early 2021.
Outside the US, several regulatory author-
ities have processes in place to recognize
standards within their jurisdictions. Globally,
SDOs have established standards development
processes, described in the following section.
Standards Development Process
A ‘consensus standard’ is designated as such
because it takes all stakeholders’ interests into
consideration and defines what they have agreed.
Consensus is considered a general agree-
ment, characterized by the absence of sustained
opposition to substantial issues by any import-
ant stakeholders, through a process that takes
all concerned parties interests into account and
reconciles conflicting arguments. However, it
is important to remember consensus need not
imply unanimity but rather agreement to most
of the proposed requirements or guidelines by
the majority of the stakeholders. Care also is
taken to ensure a standard does not confer a
competitive advantage on individual operators.
The standardization process encom-
passes standards’ development, promulgation,
implementation and compliance. While some
governmental bodies develop standards, most
are written by nongovernmental entities, several
of which were profiled earlier in this chap-
ter. Those organizations follow a transparent
process open to public scrutiny, where partic-
ipation is balanced and an appeals process is
included. Behind each medical device standard
is a comprehensive process including extensive
data gathering, analysis and discussion from all
stakeholders’ perspectives and agreement on
critical factors. Stakeholders, such as regulatory
agencies and IMDRF, support standards’ use
by referencing them in guidance documents
and publications. National regulatory authority
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
19
16
20
17
21
18
22
Global Medical Device Regulatory Strategy
(SMS), is responsible for coordinating all
CDRH consensus standards’ activities within
its assigned technical area with relevant SDOs.
The recognition process begins when an STG
identifies an existing and needed standard
within its technical area and prioritizes required
activities per common criteria. Then, the STG
coordinates an assessment of whether the stan-
dard can be used to meet a particular premarket
or statutory requirement. Upon completing the
assessment, it then recommends the standard be
recognized, as whole or a part, through publica-
tion in the Federal Register. The Federal Register
notice includes not only the newly recognized
standards it also includes modification to the
previously recognized standard and identifies
any previously recognized standard(s) that no
longer will be recognized. Any medical device
industry stakeholder may propose a standard for
recognition. The process includes submitting the
standard title, reference number, date and SDO.
In addition, the stakeholder must list device
types to which the standard would apply and
a brief identification of device testing, perfor-
mance and/or other characteristics a declaration
of conformity to that standard would address.
In September 2018, FDA finalized the
guidance, Appropriate Use of Voluntary Consensus
Standards in Premarket Submissions for Medical
Devices.24 This final guidance provides guidance to
industry and FDA staff about the appropriate use
of national and international voluntary consensus
standards in the preparation and evaluation of
premarket submissions for medical devices.
In accordance with amendments made
to Section 514 of the Federal Food, Drug and
Cosmetic Act by the FDA Reauthorization Act
of 2017, and as part of the enactment of the
Medical Device User Fee Amendments of 2017,
FDA intends to implement a pilot conformity
assessment initiative, entitled the Accreditation
Scheme for Conformity Assessment (ASCA).
This voluntary, pilot program is designed to
increase consistency and predictability in
FDA’s approach to assessing conformance with
ASCA-eligible standards in medical device
premarket reviews.
The ASCA pilot is intended to reduce reg-
ulatory burden by enhancing product reviewers’
confidence in medical device testing, which
should decrease the need for internal FDA
consultations, complete test report reviews and
additional information requests for standards
that are part of the pilot program. Ultimately, the
ASCA pilot is intended to help FDA ensure safe,
effective and high-quality medical devices are
available to patients without avoidable delay.25
The ASCA guidance document is expected to be
finalized in late 2020 or early 2021.
Outside the US, several regulatory author-
ities have processes in place to recognize
standards within their jurisdictions. Globally,
SDOs have established standards development
processes, described in the following section.
Standards Development Process
A ‘consensus standard’ is designated as such
because it takes all stakeholders’ interests into
consideration and defines what they have agreed.
Consensus is considered a general agree-
ment, characterized by the absence of sustained
opposition to substantial issues by any import-
ant stakeholders, through a process that takes
all concerned parties interests into account and
reconciles conflicting arguments. However, it
is important to remember consensus need not
imply unanimity but rather agreement to most
of the proposed requirements or guidelines by
the majority of the stakeholders. Care also is
taken to ensure a standard does not confer a
competitive advantage on individual operators.
The standardization process encom-
passes standards’ development, promulgation,
implementation and compliance. While some
governmental bodies develop standards, most
are written by nongovernmental entities, several
of which were profiled earlier in this chap-
ter. Those organizations follow a transparent
process open to public scrutiny, where partic-
ipation is balanced and an appeals process is
included. Behind each medical device standard
is a comprehensive process including extensive
data gathering, analysis and discussion from all
stakeholders’ perspectives and agreement on
critical factors. Stakeholders, such as regulatory
agencies and IMDRF, support standards’ use
by referencing them in guidance documents
and publications. National regulatory authority