Medical Design Briefs - December 2022 - 19

Regulatory Changes on the Horizon
In addition to the FDA, there are several
global entities focused on standardization
and good manufacturing practices affecting
life sciences. These include the International
Organization for Standardization
(ISO), International Council for Harmonization
(IHC), PIC/S, and GAMP. Official
regulatory requirements and guidelines
for medical device manufacturers are
outlined in sections 21 CFR 820.30 (design
controls), 820.40 (document controls),
820.70 (product and process controls) of
the U.S. federal code, as well as ISO
13485:2016. The FDA's Title 21 CFR Part
11 outlines compliance requirements for
electronic records, including signatures.
It is critical to be up to date on regulations
that directly impact the organization.
It is further critical to be aware when regulations
change. So, what changes can be
expected? This can be answered by asking
some additional questions.
How will harmonizing with ISO 13485
impact 21 CFR Part 820 Quality System
Regulations and ultimately an OEM's
quality management system? Industry will
know for sure when the FDA begins providing
training on the final Quality Management
System Regulation (QMSR) rule
once it is implemented. Currently, sections
with differences include Document
Controls (subpart D), Labeling and Packaging
Control (subpart K), Records (subpart
M), and Servicing (subpart N).4 Medical
device OEMs should be familiar with
(if not certified to) ISO 13485 and be prepared
to revise workflows, documents (including
SOPs), and training. The FDA
announced that the most notable difference
between the two is the risk management
requirements integrated throughout
ISO 13485.5 A digital solution is
crucial here - one that offers built-in risk
management tools allowing the OEM to
identify and offset risk to avoid nonconformances
and execute CAPAs.
What is the FDA's computer software assurance
(CSA) guidance all about? The
FDA recognizes that there are onerous and
confusing regulations surrounding computer
system validation. These have impeded
the adoption of automation and digital
technologies that can ultimately yield the
highest and most timely benefits for consumers.
Compliance has displaced quality
in this instance. The FDA's aim is to grant
flexibility to organizations to ensure software
quality by targeting higher-level processes
as well as particular features that diMedical
Design Briefs, December 2022
rectly impact product safety and efficacy.6
This puts into relief the FDA's emphasis on
digital transformation and automation to
keep pace with the technological advantages
of Industry 4.0. What it means for OEMs
is that they need to find a seasoned software
vendor - one that can leverage their
experience to identify and address these
highest areas of concern. This enables the
company to be a step ahead as soon as the
solution is implemented.
The Only Constant Is Change
As one modern movie character stated,
" Prepare to be surprised. " Change is coming
and always will. Fortunately, with a digital
solution, OEMs can incorporate necessary
changes while navigating inherent risks
more efficiently than by using paper-based
documents. A digital solution can help the
company properly focus efforts on areas
that present the organization with the most
risk and ensure ongoing compliance. Consequently,
the company will be able to continue
operations as it evolves systematically
and organizationally. Once the company
finds this digital sweet spot - the perfect
balance between change and risk - change
no longer delays time to market but can
hopefully expedite it.
References
1. How to Address the Top 6 Pains in DHF Management, "
Matt Lowe, MasterControl, Inc., https://
www.mastercontrol.com/resource-center/documents/top-device-history-record-pain-points.
2.
Inspectional Observation FY 2021 data set, " FDA
web site Inspection Observations page, Nov. 24,
2020, https://www.fda.gov/inspections-complianceenforcement-and-criminal-investigations/
inspection-references/inspection-observations.
3.
CDRH Learn: Documents, Change Control, and Records, "
Joseph Tartal, Division of Industry and Consumer
Education, U.S. FDA, accessed August 2022.
4. Medical Devices; Quality System Regulation
Amendments, " U.S. FDA, Feb. 23, 2022, https://
www.fda.gov/media/118202/download.
5. Proposed Rule: Quality System Regulation
Amendments - FAQ, " U.S. FDA, current as of
01/22/2022, https://www.fda.gov/medical-devices/quality-system-qs-regulationmedicaldevice-good-manufacturing-practices/proposed-rule-quality-system-regulation-amendments-frequently-asked-questions.
6.
CSA vs CSV: FDA's New Guidance for Software Assurance, "
Mohamed Benkirane, Critical Manufacturing,
Feb 8, 2021, https://www.criticalmanufacturing.
com/blog/csa-vs-csv-fda-new-guidance-for-softwareassurance.
This
article was written by Nate Henriod
, Senior Product Manager, MasterControl,
Salt Lake City, UT. In this role,
he works with beta customers to build
the Advanced Quality Event Management
(QEM) product. For more information,
visit www.mastercontrol.com.
Contact: nhenriod@mastercontrol.com.
www.medicaldesignbriefs.com
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Medical Design Briefs - December 2022

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Medical Design Briefs - December 2022 - COV1A
Medical Design Briefs - December 2022 - COV1B
Medical Design Briefs - December 2022 - Cov1
Medical Design Briefs - December 2022 - Cov2
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