Streamlining the Regulatory Path to Market for Low-Risk Med Devices | Page 6

• Will physicians, health care workers, patients,
or non-skilled users administer the device?

DEFINE OFF-LABEL USE AND
CONTRAINDICATIONS
• Specify what the device cannot treat.
• Specify who it cannot treat.
• Describe cautionary use conditions.
• Detail warnings with use
(i.e., power supply, use of force, etc.).

Developing a Regulatory
and Strategic Pathway
Quality System Regulation/Current Good
Manufacturing Practices. The Quality System
Regulation is a component of the general controls
that apply to all medical devices, including those
that are exempt from FDA review. Quality System
Regulation includes requirements related to the
methods used in, and the facilities and controls used
for, designing, manufacturing, packaging, labeling,
storing, installing, and servicing of medical devices
intended for human use. Following Quality System
Regulations is necessary for developing preproduction
design controls and achieving consistency with
Quality System requirements worldwide.

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• Quality management and organization
• Device design
• Buildings
• Equipment
• Purchasing and handling of components
• Production and process controls
• Packaging and labeling controls
• Device evaluation
• Distribution
• Installation
• Complaint handling
• Servicing
• Records
Design Controls. A component of CGMPs
design controls are an interrelated set of practices
and procedures for systematically assessing the
development process. Design controls increase the
likelihood of smooth transitions from concept to
production of a device.
Because the design control process is revisited many
times during the life of a product, deficiencies in design
and discrepancies between the proposed designs and
requirements are made evident and corrected earlier in
the development process.
Design control applies to all changes to the device
or manufacturing process design, including changes
after a device is marketed. Such changes can
include evolutionary changes such as performance
enhancements as well as revolutionary changes such
as corrective actions resulting from a product failure.

à

à

à

DEFINE WHO CAN ADMINISTER
USE OF THE DEVICE

QUALITY SYSTEM
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REGULATION COVERS

VALIDATION

Design
Process

à

• Is it for hospital use only?
• Can it be used during home care?
• Does it need to be used under sterile conditions?
• Does it need to be used with specific
accessories or other devices, software or drugs?

à

VERIFICATION

REVIEW

‘‘

‘Small businesses’ are eligible
for a significant reduction in some
of those fees, as well as a one-time
waiver for their first Premarket
Approval Application.
Design Control Process
Consensus Standards. Consensus standards are
standards for evaluating medical devices before they
are cleared for market entry. The FDA believes that
meeting recognized consensus standards can support
the safety and/or effectiveness of a medical device.
To that end, consensus standards are also a means
to streamline the premarket review process, helping
medical device manufacturers reduce regulatory
obstacles and satisfy FDA requirements.
It is important to use consensus standards that the
FDA recognizes for a particular device. To find out
if the FDA believes a standard can apply to a device,
go to the Supplemental Information Sheet (SIS) posted
on the FDA website. For each recognized standard,
the following is specified:
• address(es) where the standard can be obtained
• the extent of recognition of the standard
• a list of devices or device categories affected
by the recognition
• other information pertinent to the use of the
standard by industry and in the premarket
review and postmarket process

Figure 2. Application
of Design Controls to
Waterfall Design Process.

Design
Output

à

DEFINE CONDITIONS AND ENVIRONMENTS
FOR USING THE DEVICE

To help manufacturers comply with requirements of
global regulators such as the FDA, the International
Organization for Standardization (ISO) has generated
standards for management systems.

Design
Input

à

• What type of device is it, and how does it work?
• What therapeutic need does it meet and how?
• What patient population can be treated?

User
Needs

à

DESCRIBE THE DEVICE

The FDA’s Quality System Regulation does not describe
in detail how a manufacturer should produce a specific
device. Instead, each manufacturer must develop its
own procedures and processes specific for its device.

à

TO DRAFT THE INTENDED
USE SECTION OF A 510(K):

Medical
Device

Source: © All Rights
Reserved. Application of
Design Controls to Waterfall
Design Process. Health
Canada – Medical Devices
Bureau, 2005. Reproduced
with permission from the
Minister of Health, 2015.

Submitters should, for example, identify the consensus
standard by its complete title, state whether it is FDArecognized, and provide adequate justifications for any
deviations from the standard.
Application Fees. Medical device companies pay fees
when registering their business and listing their devices
with the FDA and when submitting an application or a
notification for marketing a new medical device.
“Small businesses” are eligible for a significant
reduction in some of those fees, as well as a one-time
waiver for their first Premarket Approval Application.
A small business is defined as having gross receipts or
sales of no more than $100 million for the most recent
tax year. The FDA guidance document on user fees
for small businesses can be found on their website.
Conclusion
Medical devices are a highly diverse group of
products, and the processes for their regulatory
review and clearance are variable. Lower-risk devices
(Class I and II) generally require less time and expense
to meet the FDA’s standards for safety and efficacy
than Class III devices, but meeting the standards
that do exist can be complex. Developing a highlevel strategy for meeting regulatory requirements
and implementing quality control systems early in
a product’s lifecycle can save resources and improve
the device’s safety and performance in patients.

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