editorial
advisory board
Editor
Negin Shamsian
negin.shamsian@markallengroup.com
Chief Sub Editor
Lindsey Stewart
Sub Editor
Brian Cooper
Commercial Manager
Emma Blick
emm.blick@markallengroup.com
Circulation Director
Sally Boettcher
sally.boettcher@markallengroup.com
Production
Larry Oakes
Managing Director
Anthony Kerr
anthony.kerr@markallengroup.com
Associate Publisher
Sophie Gardner
Chief Executive Officer
Ben Allen
Journal of Wound Care is published by
MA Healthcare Ltd, St Jude’s Church,
Dulwich Road, London SE24 0PB
Tel: +44 (0)20 7738 5454
Email: jwc@markallengroup.com
Websites: www.journalofwoundcare.com
www.markallengroup.com
Journal of Wound Care is published by
MA Healthcare Ltd, St Jude’s Church,
Dulwich Road, London SE24 0PB
Tel: +44 (0)20 7738 5454
Email: jwc@markallengroup.com
Websites: www.journalofwoundcare.com
© MA Healthcare Ltd, 2020. All rights
reserved. No part of the Journal of Wound
Care may be reproduced, stored in a retrieval
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The views expressed do not necessarily
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of Wound Care. Advertisements in the journal
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ISSN 0969-0700
Printed by Pensord Press Ltd,
Blackwood, NP12 2YA
supplement editorial
Innovation in wound care
products: a FDA regulatory
perspective
T
he US Food and Drug Administration (FDA)
recognises the importance of bringing high-
quality, innovative wound care products to the
market. This editorial focuses on how the
Center for Devices and Radiological Health
(CDRH) reviews and supports the development of new
devices for wound care. Note that the FDA may regulate a
wound care product as a drug, device, biological product
or combination product.1 Generally, drugs are reviewed in
the Center for Drug Evaluation and Research (CDER),
devices are reviewed in the Center for Devices and
Radiological Health (CDRH) and biological products are
reviewed in the Center for Biologics Evaluation and
Cynthia J Chang, PhD
Research (CBER). A combination product is a product Office of Product Evaluation and
composed of any combination of a drug and a device; a Quality, Center for Devices and
biological product and a device; a drug and a biological Radiological Health, US Food
product; or a drug, a device and a biological product.2,3 If and Drug Administration, US
the classification of a product as a drug, device, biological
product or combination product is unclear or in dispute,
the Office of Combination Products (OCP) assigns the lead
agency centre for the product’s premarket review
and regulation.1
Medical devices are classified into one of three classes—
Class I, II or III—based on their risks and the regulatory
controls necessary to provide a reasonable assurance of
safety and effectiveness. Class I devices generally pose the
lowest risk to the patient and are subject to general controls
to provide a reasonable assurance of safety and
effectiveness.4 Devices which cannot be classified into
Class I because general controls, by themselves, are Mehdi Kazemzadeh-Narbat,
PhD. Office of Product Evaluation
insufficient to provide reasonable assurance of safety and
and Quality, Center for Devices
effectiveness, may be classified into Class II if sufficient and Radiological Health, US Food
information exists to establish special controls that, in and Drug Administration, US
addition to general controls, are adequate to provide such Musculoskeletal Clinical
assurance. This class of devices usually requires a premarket Regulatory Advisers (MCRA),
Washington DC, US
notification submission, or 510(k), which involves
comparison of a new device to a predicate device to meet
the ‘substantial equivalence’ review standard.5,6 Class III devices are those for
which insufficient information exists to determine that general controls are
sufficient to provide reasonable assurance of its safety and effectiveness or that
application of special controls would provide such assurance. In addition,
Class III devices are life-supporting or life-sustaining, for a use which is of
substantial importance in preventing impairment of human health, or present
a potential unreasonable risk of illness or injury. Class III devices require a
Premarket Approval (PMA) application, which is an independent
demonstration of reasonable assurance of safety and effectiveness.7 Some
devices are unclassified,8 and these are reviewed through the 510(k) pathway.
CDRH regulates a variety of wound care devices across all classes. For
example, wound dressing devices may be Class I, II, III or unclassified,
JOURNAL OF WOUND CARE  NORTH AMERICAN SUPPLEMENT VOL 30, NO 2, FEBRUARY 2021 S3
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 supplement editorial
depending on their intended use and technology.
Most antimicrobial-containing wound dressings are
intended to cover a wound and keep it moist and are
reviewed under the unclassified product code FRO
(dressing, wound, drug). Interactive wound and burn
dressings that promote or accelerate wound healing
are Class III devices.
For novel devices, the De Novo process allows
classification into Class I or II when certain criteria are
met.9 Several novel devices recently classified through
the De Novo pathway into Class II may serve as
predicates for future 510(k) submissions, including a
negative pressure wound therapy device for reduction
of wound complications, an extracorporeal shock
wave device for treatment of hard-to-heal wounds, a
device to detect bacterial protease activity in hard-to-
heal wound fluid, a pressure ulcer management tool
and a wound autofluorescence imaging device.
In any premarket submission, clinical data may be
requested when bench and animal performance data
are not sufficient to demonstrate substantial
equivalence or reasonable assurance of safety and
effectiveness, and they may be provided in the form of
an Investigational Device Exemption (IDE) study,10
literature, real-world evidence (RWE) or other forms of
valid scientific evidence. Developers of innovative
devices, including those with novel materials or new
indications for use, are encouraged to consider
submitting a pre-submission (Q-Submission) for
References
1 US Food & Drug Administration. Classification of products as drugs and
devices and additional product classification issues: guidance for industry
and FDA staff. 2017. https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/classification-products-drugs-and-
devices-and-additional-product-classification-issues (accessed 22
December 2020)
2 US Food & Drug Administration. Combination product definition
combination product types. 2018. https://www.fda.gov/combination-
products/about-combination-products/
combination-product-definition-combination-product-types (accessed 22
December 2020)
3 US Food & Drug Administration. Combination products guidance
documents. 2020. https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/combination-products-guidance-
documents (accessed 22 December 2020)
4 US Food & Drug Administration. Medical device exemptions 510(k) and
GMP requirements. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfpcd/315.cfm (accessed 22 December 2020)
5 US Food & Drug Administration. The 510(k) program: evaluating
substantial equivalence in premarket notifications [510(k)]: guidance for
industry and Food and Drug Administration staff. 2014. https://www.fda.
gov/regulatory-information/search-fda-guidance-documents/510k-
program-evaluating-substantial-equivalence-premarket-notifications-510k
(accessed 22 December 2020)
6 US Food & Drug Administration. Format for traditional and abbreviated
510(k)s: guidance for industry and FDA staff. 2019. https://www.fda.gov/
regulatory-information/search-fda-guidance-documents/format-
traditional-and-abbreviated-510ks (accessed 22 December 2020)
7 US Food & Drug Administration. Premarket approval (PMA). 2019.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm
(accessed 22 December 2020)
8 US Food & Drug Administration. Medical device classification product
codes: guidance for Food and Drug Administration staff. 2013. https://
www.fda.gov/regulatory-information/search-fda-guidance-documents/
medical-device-classification-product-codes-guidance-industry-and-
S4 JOURNAL OF WOUND CARE  NORTH AMERICAN SUPPLEMENT VOL 30, NO 2, FEBRUARY 2021
feedback on the type of information that may be
important to provide. 11 CDRH encourages pre-
submissions for those who are designing clinical
studies and is open to considering a variety of potential
clinical endpoints.
To promote innovation, CDRH has several programs
and guidances relevant to the wound care community.
The breakthrough devices program allows prioritised
review for eligible products that provide for more
effective treatment or diagnosis of life-threatening or
irreversibly debilitating diseases or conditions.12 The
Medical Device Development Tools program13 allows
the FDA to qualify clinical outcome assessments
(including patient-reported outcomes), biomarker
tests and nonclinical assessment models for use in the
development and review of medical devices. For those
considering how to provide clinical data for the FDA’s
regulatory decision-making, the FDA has published
guidance on how RWE, which may be generated by
data from electronic health records, registries, claims
and billing data, and other sources, may be used as an
alternative to traditional clinical data.14 The FDA is
committed to supporting the wound care community,
including industry, researchers, clinicians and patients,
in using these initiatives. We encourage interested
parties to explore these pathways and programs, and
to engage with the FDA for a collaborative approach
in the development of innovative wound care
devices.  JWC
food-and-drug-administration-staff (accessed 22 December 2020)
9 US Food & Drug Administration. De Novo classification process
(evaluation of automatic class III designation): guidance for industry and
Food and Drug Administration staff. 2017. https://www.fda.gov/
regulatory-information/search-fda-guidance-documents/de-novo-
classification-process-evaluation-automatic-class-iii-designation
(accessed 22 December 2020)
10 US Food & Drug Administration. Design considerations for pivotal
clinical investigations for medical devices: guidance for industry, clinical
investigators, institutional review boards and Food and Drug
Administration staff. 2013. https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/design-considerations-pivotal-clinical-
investigations-medical-devices (accessed 22 December 2020)
11 US Food & Drug Administration. Requests for feedback and meetings
for medical device submissions: the Q-Submission program: guidance for
industry and Food and Drug Administration staff. (2019). https://www.fda.
gov/regulatory-information/search-fda-guidance-documents/requests-
feedback-and-meetings-medical-device-submissions-q-submission-
program (accessed 22 December 2020)
12 US Food & Drug Administration. Breakthrough devices program:
guidance for industry and Food and Drug Administration staff. 2018.
https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/breakthrough-devices-program (accessed 22 December 2020)
13 US Food & Drug Administration. Qualification of medical device
development tools: guidance for industry, tool developers, and Food and
Drug Adminsitration staff. 2017. https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/
qualification-medical-device-development-tools (accessed 22 December
2020)
14 US Food & Drug Administration. Use of real-world evidence to support
regulatory decision-making for medical devices: guidance for industry and
Food and Drug Administration staff. 2017. https://www.fda.gov/
regulatory-information/search-fda-guidance-documents/use-real-world-
evidence-support-regulatory-decision-making-medical-devices (accessed
22 December 2020)
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