NEMA ei November 2016 - 14MITA


MITA

Strategic Priority 6:

Focusing on
Regulatory Environment

Enhance the regulatory environment
to support growth and innovation
in imaging

Diane Wurzburger, Executive, Regulatory Affairs, GE Healthcare
Ms. Wurzburger chairs MITA's Technical and Regulatory Committee.
high level issues (e.g., x-ray emissions) that might be
MDUFA
appropriate to document.
When MDUFA IV negotiations began in September
2015, MITA's goals were to improve timeliness,
CONTRAST
consistency, and predictability throughout the
The current FDA regulatory pathway for
premarket review process. The team advocated
premarket clearance of imaging device
for improved performance in exchange
indications that may be used with
for increased resources. The resulting
contrast agents is complicated,
agreement expands these
ITA's Technical and
forcing device manufacturers
performance metrics:
Regulatory Committee
to navigate a process that may
(TRC) promotes a regulatory
include multiple FDA centers.
*	 Reduction in total time
environment that supports growth and
The TRC is dedicated to a
to 108 days for 510(k)
innovation in medical imaging.
streamlined and timely
decisions, which
pathway-to-market
demonstrate that a
In 2016, the TRC set three priorities: successful
that allows imaging
device is at least as safe
Medical Device User Fee Amendments
applications and contrast
and effective as one
(MDUFA) negotiations; critical to quality (CtQ)
agents to keep pace with
that is not subject to
engagement, which is part of the U.S. Food and Drug
innovative performance
premarket approval
Administration (FDA) initiative related to medical
and standards of care.
device quality; and resolving the contrast issue, a
*	 More rigorous
MITA
collaborated
long-standing MITA project to create a reasonable
scheduling and feedback
with
the
Council on
regulatory pathway for clearance of medical
goals for pre-submission
Radionuclides
and
devices with contrast agents.
meetings
Radiopharmaceuticals,
*	 Traceability of all reviewer
the contrast agent trade
The TRC works with the FDA on key issues
questions and requests
association,
to develop a
related to medical imaging technology
for additional information
legislative
framework
for
and supporting other MITA sections
to regulation, guidance,
clearance of medical imaging
and committees in their
standards, or relevant scientific
devices involving the use of
regulatory efforts.
evidence
contrast agents.
*	 New quality management targets and
FDA INTERACTION
standards conformity assessment
MITA sections and committees seek opportunities
*	 Quarterly summary medical device reporting
with FDA leadership and staff that will establish it as a
valuable stakeholder for discussions regarding medical
CTQ ENGAGEMENT
device policy, including
Since 2011, the FDA collaborates with stakeholders
on defining activities and characteristics that drive
*	 influencing the agency's priorities, policy positions,
product and manufacturing quality. The goal is to
and regulatory pathways;
focus attention on attributes and data that promote
*	 collaborations with other associations to develop
the practice and culture of quality within firms-as
consensus on challenging policy issues that impact
opposed to compliance with regulations alone-and
market access of medical imaging devices; and
thereby increase the quality of devices.
*	 submitting comment letters on relevant FDA Federal
Knowing what device attributes are critical to device
Register notices, draft guidance documents, and
quality allows product development teams-and
public meeting dockets.
ultimately manufacturing teams-to ensure the right
These interactions are strategically planned to influence
focus is on items that are most critical to safe and
the development and implementation of regulatory
effective performance. MITA is considering whether
priorities and policies that are aligned with MITA goals
there are issues for medical imaging technology that
and support growth of the diagnostic imaging market
could be addressed, such as whether there are any
as well as continued patient access. ei

M

14 MITA

NEMA electroindustry *  November 2016



Table of Contents for the Digital Edition of NEMA ei November 2016

Comments from the President
Breaking News
Survey: Benchmarking, Transparency Work
Centerfold: A look inside the Medical Imaging & Technology Alliance (MITA), a division of NEMA
2017 NEC Broadens Requirements for SPDs
Power Surges: Protect Your Home!
Grid Modernization Promotes Sustainability
Advocacy
Code & Standards
Revision Simplifies Magnet Wire Production
International
Business Analysis
NEMA ei November 2016 - Cover1
NEMA ei November 2016 - Cover2
NEMA ei November 2016 - 1
NEMA ei November 2016 - 2
NEMA ei November 2016 - 3
NEMA ei November 2016 - 4
NEMA ei November 2016 - Comments from the President
NEMA ei November 2016 - Breaking News
NEMA ei November 2016 - 7
NEMA ei November 2016 - Survey: Benchmarking, Transparency Work
NEMA ei November 2016 - 9
NEMA ei November 2016 - 10
NEMA ei November 2016 - 11
NEMA ei November 2016 - 12
NEMA ei November 2016 - Centerfold: A look inside the Medical Imaging & Technology Alliance (MITA), a division of NEMA
NEMA ei November 2016 - 2MITA
NEMA ei November 2016 - 3MITA
NEMA ei November 2016 - 4MITA
NEMA ei November 2016 - 5MITA
NEMA ei November 2016 - 6MITA
NEMA ei November 2016 - 7MITA
NEMA ei November 2016 - 8MITA
NEMA ei November 2016 - 9MITA
NEMA ei November 2016 - 10MITA
NEMA ei November 2016 - 11MITA
NEMA ei November 2016 - 12MITA
NEMA ei November 2016 - 13MITA
NEMA ei November 2016 - 14MITA
NEMA ei November 2016 - 15MITA
NEMA ei November 2016 - 16MITA
NEMA ei November 2016 - 2017 NEC Broadens Requirements for SPDs
NEMA ei November 2016 - 14
NEMA ei November 2016 - 15
NEMA ei November 2016 - Power Surges: Protect Your Home!
NEMA ei November 2016 - 17
NEMA ei November 2016 - 18
NEMA ei November 2016 - 19
NEMA ei November 2016 - Advocacy
NEMA ei November 2016 - 21
NEMA ei November 2016 - Code & Standards
NEMA ei November 2016 - Revision Simplifies Magnet Wire Production
NEMA ei November 2016 - 24
NEMA ei November 2016 - International
NEMA ei November 2016 - Business Analysis
NEMA ei November 2016 - 27
NEMA ei November 2016 - 28
NEMA ei November 2016 - Cover3
NEMA ei November 2016 - Cover4
https://www.nxtbook.com/ygsreprints/NEMA/g78283_nema_july2017
https://www.nxtbook.com/ygsreprints/NEMA/g77252_nema_june2017
https://www.nxtbook.com/ygsreprints/NEMA/g75897_nema_may2017
https://www.nxtbook.com/ygsreprints/NEMA/g74413_nema_april2017
https://www.nxtbook.com/ygsreprints/NEMA/g73647_nema_march2017
https://www.nxtbook.com/ygsreprints/NEMA/g72371_nema_february2017
https://www.nxtbook.com/ygsreprints/NEMA/g71716_nema_january2017
https://www.nxtbook.com/ygsreprints/NEMA/g70286_nema_december16
https://www.nxtbook.com/ygsreprints/NEMA/g68064_nema_november16
https://www.nxtbook.com/ygsreprints/NEMA/g67417_nema_october16
https://www.nxtbook.com/ygsreprints/NEMA/g65247_nema_september16
https://www.nxtbook.com/ygsreprints/NEMA/g64195_nema_august16
https://www.nxtbook.com/ygsreprints/NEMA/g62957_nema_july16
https://www.nxtbook.com/ygsreprints/NEMA/g62621_nema_june16
https://www.nxtbook.com/ygsreprints/NEMA/g61522_nema_may16
https://www.nxtbook.com/ygsreprints/NEMA/g60076_nema_apr16
https://www.nxtbook.com/ygsreprints/NEMA/g59228_nema_mar16
https://www.nxtbook.com/ygsreprints/NEMA/Nema_feb16
https://www.nxtbook.com/ygsreprints/NEMA/g56839_nema_jan16
https://www.nxtbook.com/ygsreprints/NEMA/g56034_nema_dec15
https://www.nxtbook.com/ygsreprints/NEMA/g54875_nema_nov15
https://www.nxtbook.com/ygsreprints/NEMA/g54656_nema_oct15
https://www.nxtbook.com/ygsreprints/NEMA/g53383_nema_ei_sept15
https://www.nxtbook.com/ygsreprints/NEMA/ei_aug2015
https://www.nxtbook.com/ygsreprints/NEMA/g51911
https://www.nxtbook.com/ygsreprints/NEMA/G51101_nema_ei_june2015
https://www.nxtbook.com/ygsreprints/NEMA/g50122_nema_ei_may2015
https://www.nxtbook.com/ygsreprints/NEMA/g49416_nema_ei_april2015
https://www.nxtbook.com/ygsreprints/NEMA/g48729_nema_ei_march2015
https://www.nxtbook.com/ygsreprints/NEMA/g47992_nema_ei_feb2015
https://www.nxtbook.com/ygsreprints/NEMA/g47420_nema_jan2015
https://www.nxtbook.com/ygsreprints/NEMA/g46789_nema_ei_dec2014
https://www.nxtbook.com/ygsreprints/NEMA/g45735_nema_nov14
https://www.nxtbook.com/ygsreprints/NEMA/g44837_nema_ei_October2014
https://www.nxtbook.com/ygsreprints/NEMA/g4438_nema_sept2014
https://www.nxtbook.com/ygsreprints/NEMA/g43520_nema_aug14
https://www.nxtbook.com/ygsreprints/NEMA/G42960_nema_ei_july14
https://www.nxtbook.com/ygsreprints/NEMA/g42238_nema_ei_june14
https://www.nxtbook.com/ygsreprints/NEMA/g41547_nema_ei_May14
https://www.nxtbook.com/ygsreprints/NEMA/g40829_nema_ei_apr14
https://www.nxtbook.com/ygsreprints/NEMA/g40178_nema_ei_Mar14
https://www.nxtbook.com/ygsreprints/NEMA/g309513_nema_ei_feb14
https://www.nxtbook.com/ygsreprints/NEMA/g39026_nema_ei_jan14
https://www.nxtbook.com/ygsreprints/NEMA/g38680_nema_ei_dec13
https://www.nxtbook.com/ygsreprints/NEMA/G37864_nema_ei_nov13
https://www.nxtbook.com/ygsreprints/NEMA/G36899_nema_ei_oct13
https://www.nxtbook.com/ygsreprints/NEMA/g36301_nema_ei_sept13
https://www.nxtbook.com/ygsreprints/NEMA/G35638_NEMA_ei_aug13
https://www.nxtbook.com/ygsreprints/NEMA/G35075_NEMA_ei_jul13
https://www.nxtbook.com/ygsreprints/NEMA/g34530_nema_ei_June13
https://www.nxtbook.com/ygsreprints/NEMA/g33413_nema_ei_may13
https://www.nxtbook.com/ygsreprints/NEMA/g32528_nema_ei_march13
https://www.nxtbook.com/ygsreprints/NEMA/g31850_nema_ei_feb13
https://www.nxtbook.com/ygsreprints/NEMA/g31330_nema_ei_Jan13
https://www.nxtbook.com/ygsreprints/NEMA/g30890_nema_ei_dec12
https://www.nxtbook.com/ygsreprints/NEMA/g29979_nema_ei_nov12
https://www.nxtbook.com/ygsreprints/NEMA/g29308_nema_ei_oct12
https://www.nxtbook.com/ygsreprints/NEMA/g28512_nema_ei_sept12
https://www.nxtbook.com/ygsreprints/NEMA/g27967_nema_aug12
https://www.nxtbook.com/ygsreprints/NEMA/g27429_nema_ei_july2012
https://www.nxtbook.com/ygsreprints/NEMA/g26904_nema_eijune2012
https://www.nxtbook.com/ygsreprints/NEMA/g25763_nema_ei_may12
https://www.nxtbook.com/ygsreprints/NEMA/g24906_nema_ei_april12
https://www.nxtbook.com/ygsreprints/NEMA/g24391_nema_ei_mar12
https://www.nxtbook.com/ygsreprints/NEMA/g24069_nema_ei_feb12
https://www.nxtbook.com/ygsreprints/NEMA/g23809_nema_ei_jan12
https://www.nxtbook.com/ygsreprints/NEMA/g23198_nema_ei_dec11
https://www.nxtbook.com/ygsreprints/NEMA/G22670_nema_ei_nov11
https://www.nxtbook.com/ygsreprints/NEMA/g22157_nema_ei_oct11
https://www.nxtbook.com/ygsreprints/NEMA/g21520_nema_ei_sept11
https://www.nxtbook.com/ygsreprints/NEMA/g21115_nema_ei_aug11
https://www.nxtbook.com/ygsreprints/NEMA/g20729_nema_ei_july11
https://www.nxtbook.com/ygsreprints/NEMA/g19430_nema_ei_may11
https://www.nxtbook.com/ygsreprints/NEMA/g19141_nema_ei_april11
https://www.nxtbook.com/ygsreprints/NEMA/g18610_nema_ei_march11
https://www.nxtbook.com/ygsreprints/NEMA/g18431_nema_ei_feb11
https://www.nxtbook.com/ygsreprints/NEMA/g17897_nema_ei_jan11
https://www.nxtbook.com/ygsreprints/NEMA/g17260_nema_ei_dec10
https://www.nxtbook.com/ygsreprints/NEMA/g17025_nema_ei_nov10
https://www.nxtbook.com/ygsreprints/NEMA/g16338_nema_ei_oct10
https://www.nxtbook.com/ygsreprints/NEMA/g15947_nema_ei_sept10
https://www.nxtbook.com/ygsreprints/NEMA/g15556_nema_ei_aug10
https://www.nxtbookmedia.com