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GUEST COLUMN | JULY 26, 2021




FDA SEEKS PUBLIC COMMENT ON DRAFT GUIDANCE ON REMANUFACTURING MEDICAL DEVICES

By Mark Durivage, Quality Systems Compliance LLC



On June 24, 2021, the FDA released a draft guidance, Remanufacturing of Medical
Devices Draft Guidance for Industry and Food and Drug Administration Staff, for
public comment in the Federal Register to help clarify whether repair,
servicing, and reprocessing activities performed on devices are likely
considered remanufacturing. The clarification is intended to facilitate
consistency and better interpretation of applicable statutory and regulatory
requirements. The guidance applies to all class I, II, or III reusable medical
devices, including software and electronic products. The guidance does not apply
to reprocessed single-use devices, regardless of classification. The comment
period closes 60 days after the draft guidance was posted on June 24, so the
deadline for comments is on or around August 23.

Definitions

The guidance provides definitions to reflect updated understanding and practice:

Remanufacture: Process, condition, renovate, repackage, restore, or any other
act done to a finished device that significantly changes the finished device’s
performance or safety specifications, or intended use. (21 CFR 820.3(w)).

Repair: A type of servicing that returns a component to original specifications,
including replacing non-working components or parts outside of routine or
periodic upkeep for the current owner of the device.

Reprocessing: With respect to reusable devices, means validated processes used
to render a medical device, which has been previously used or contaminated, fit
for a subsequent single use on a patient. These processes are designed to remove
soil and contaminants by cleaning and to inactivate microorganisms by
disinfection or sterilization.

Service: Repair and/or preventive or routine maintenance of one or more parts in
a finished device, after distribution, for purposes of returning it to the
safety and performance specifications established by the OEM and to meet its
original intended use. Servicing excludes activities that significantly change
the finished device’s safety or performance specifications or intended use.

Guiding Principles

The proposed guidance focuses on six fundamental principles to decide if
activities meet the definition of remanufacturing:

Principle 1: Assess whether there is a change to the intended use.

Principle 2: Determine whether the activities, individually and cumulatively,
significantly change the safety or performance specifications of a finished
device.

Principle 3: Evaluate whether any changes to a device require a new marketing
submission.

Principle 4: Assess component/part/material dimensional and performance
specifications.

Principle 5: Employ a risk-based approach.

Principle 6: Adequately document decision-making.

I’ll discuss each principle in more detail below.


PRINCIPLE 1: ASSESSING WHETHER THERE IS A CHANGE TO THE INTENDED USE

The intended use of the device is defined as the general purpose of the device
or its function, which encompasses the indications for use (21 CFR 801.4). If
the purpose of the servicing activity is to return the device to the safety and
performance specifications established by the original equipment manufacturer
(OEM) and to meet its original intended use, the activity is not considered
remanufacturing. However, if the servicing activity alters the original safety
and performance specifications, the activity may be considered remanufacturing
and will need a formal evaluation.


PRINCIPLE 2: DETERMINING WHETHER THE ACTIVITIES SIGNIFICANTLY CHANGE THE SAFETY
OR PERFORMANCE SPECIFICATIONS

Let’s revisit the definition of “remanufacture” provided above. Remanufacture
“significantly changes” the finished device’s performance or safety
specifications or intended use. Repair, servicing, and reprocessing activities
that are not meant to significantly change the original safety or performance
specifications of the device should be evaluated to determine whether they do
significantly change the finished device’s original safety or performance
specifications. Additionally, cumulative changes made during repair, servicing,
and reprocessing activities should be evaluated to verify the original safety or
performance specifications of the device.


PRINCIPLE 3: EVALUATING WHETHER ANY CHANGES TO A DEVICE REQUIRE A NEW MARKETING
SUBMISSION

21 CFR Part 807 Establishment Registration and Device Listing for Manufacturers
and Initial Importers of Devices provides requirements for premarket
notification for changes that affect the safety, effectiveness, or intended use
of class II medical devices. Therefore, evaluate any repair, servicing, and
reprocessing activities to determine whether they do significantly change the
finished device’s original safety, effectiveness, or intended use and thus
require a new 510(k) submission.


PRINCIPLE 4: ASSESSING COMPONENT/PART/MATERIAL DIMENSIONAL AND PERFORMANCE
SPECIFICATIONS

Repair, servicing, and reprocessing activities that change OEM dimensional and
performance specifications, including changes in components, parts, and
materials, should be evaluated to verify the original safety or performance
specifications of the device. Significant changes may require risk-based
verification and validation testing and may require a new 510(k) submission.


PRINCIPLE 5: EMPLOYING A RISK-BASED APPROACH

The guidance recommends using a risk-based approach, such as ISO 14971: Medical
devices – Application of risk management to medical devices, when assessing
whether repair, servicing, and reprocessing activities are remanufacturing.
Specifically, your risk assessment should evaluate if any new hazards or
hazardous situations have been introduced and if any of the known hazards or
hazardous situations have changed from the finished device’s original (legally
marketed) performance or safety specifications or intended use.


PRINCIPLE 6: ADEQUATELY DOCUMENTING DECISION-MAKING

The guidance recommends documenting the rationale whether repair, servicing, and
reprocessing activities constitute remanufacturing or not. Your rationale should
be supported by and include reference to supporting verification and validation
data.

Your rationale should specify why the repair, servicing, and reprocessing
activities performed on the device do or do not significantly change the safety,
performance specifications, or intended use of the legally marketed device. It
is appropriate to leverage documentation from previous determinations from the
identical activity on the same version or model of a device. The documentation
can help support complaints, adverse events, field notifications, and FDA
inspections.


IMPORTANT CONSIDERATIONS & REMANUFACTURING DETERMINATION

In the draft guidance, the FDA states that it generally considers a significant
change to device performance or safety specifications to be one that, ”based on
verification and validation testing and/or a risk-based assessment, results in a
finished device that is outside the OEM’s performance or safety specifications
or introduces new risks or significantly modifies existing risks.”

The FDA identifies certain types of activities that the agency believes
significantly change the legally marketed device’s safety or performance
specifications, including changes to the device’s sterilization methods, changes
to the device’s reprocessing instructions, changes to the device’s control
mechanism, operating principle, or energy type, and intended use.

For repair, servicing, and reprocessing activities that change OEM dimensional
and performance specifications, including changes in components, parts, and
materials, the guidance provides a flowchart to assist in determining if
activities are likely remanufacturing.

The flowchart is intended to be used after an entity determines that there is no
significant change to intended use or the device’s sterilization methods,
reprocessing instructions, control mechanism, operating principle, or energy
type. The flowchart does not apply to software. The guidance also emphasizes the
flowchart is a visual aid intended to be used in conjunction with the
accompanying guiding principles.

As with other guidance documents with flowcharts, such as Deciding When to
Submit a 510(k) for a Change to an Existing Device and Deciding When to Submit a
510(k) for a Software Change to an Existing Device, it is a best practice to
incorporate the flowchart into your organization’s quality management system
(QMS).

Conclusion

This proposed guidance will provide industry with clarification on whether
repair, servicing, and reprocessing activities performed on devices are likely
considered remanufacturing. The flowchart used in conjunction with the six
guiding principles will help document and justify the organization’s rationale.

Submit written comments before August 23 to the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 or electronic comments to https://www.regulations.gov. Please reference
docket number FDA-2018-N-3741 and the complete title of the guidance with all
comments.

About The Author:

Mark Allen Durivage has worked as a practitioner, educator, consultant, and
author. He is Managing Principal Consultant at Quality Systems Compliance LLC,
an ASQ Fellow and SRE Fellow. Durivage primarily works with companies in the FDA
regulated industries (medical devices, human tissue, animal tissue, and
pharmaceuticals) focusing on quality management system implementation,
integration, updates, and training. Additionally, he assists companies by
providing internal and external audit support as well as FDA 483 and warning
letter response and remediation services. He earned a BAS in computer aided
machining from Siena Heights University and an MS in quality management from
Eastern Michigan University. He holds several certifications, including CRE,
CQE, CQA, CSSBB, RAC (Global), and CTBS. He has written several books available
through ASQ Quality Press, published articles in Quality Progress, and is a
frequent contributor to Life Science Connect. You can reach him at
mark.durivage@qscompliance.com with any questions or comments.



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