FDA and Internationally Regulated Medical
Devices
Frequently Asked Questions
is vested with statutory authority
to protect and enhance the public health. The
original Food and Drugs Act establishing the
FDA was passed by Congress on June 30, 1906
and signed by President Theodore Roosevelt.
It prohibits interstate commerce in misbranded
and adulterated foods, drinks and drugs.
The FDA is responsible for protecting the
public health by assuring the efficacy, safety,
and security of food, drugs, biologicals ,
medical devices, animal feed and drugs, cosmetics,
and products that emit radiation.
FDA's Center for Devices and Radiological
Health (CDRH) is responsible for regulating
companies that manufacture, repackage, re-label,
perform specified processes, and/or import
medical devices sold in the United States.
Foreign establishments that export devices
into the United States are also required to
list their devices with FDA and are subject
to on-site inspections. The CDRH also regulates
radiation-emitting electronic products (both
medical and non-medical) such as lasers, x-ray
systems, and ultrasound equipment.
FDA classifies medical devices into three
regulatory categories—class I, II, and
III—each of which depends on the level
of regulatory control necessary to assure
safety and efficacy.
- Class I devices are subject to minimal requirements
including Good Manufacturing Practice (GMP)
and other general controls.
- Class II devices must comply not only with
general controls, but also with any applicable
performance standards developed to assure
safety and efficacy.
- Class III devices are subject to Premarket
approval in addition to general controls;
generally these are life sustaining or life
supporting devices such as implants.
You can read more about device classification
and link to the Product Classification Database
by visiting the FDA official government website:
http://www.fda.gov/cdrh/devadvice/313.html.
There are basic regulatory requirements with
which manufacturers of medical devices distributed
in the United States must comply. They include:
- Submitting a Premarket notification
510(k), unless exempt, or Premarket approval
(PMA)
- Registering establishments with FDA
- Achieving a medical device listing by
FDA
- Complying with the quality system (QS)
regulations
- Meeting labeling requirements including
directions for use
- Maintaining complaint records and follow-up
investigations, as well as adhering to the
medical device reporting (MDR) process
No. Compliance with FDA regulations goes
a long way toward preparing your organization
to meet the ISO quality system standard for
medical devices, namely ISO 13485. However,
for organizations distributing medical devices
in the United States, whereas ISO conformance
is voluntary, FDA regulations are law and
take precedence.
There are differences between the regulations
and the standard that are significant enough
to require independent attention.
For example, ISO 13485 requires continual
improvement as a formal process whereas FDA
has no such requirement.
These differences remain despite significant
activity in North America, Europe, Japan,
and other countries toward harmonizing standards
and regulations governing medical devices.
As a recognized leader in FDA compliance,
STAT-A-MATRIX has been involved in this type
of training and consulting for many years.
While our work with each client remains strictly
confidential, the strategies and tactics we
have developed can provide your organization
with the guidance, understanding, and tools
you need to effectively and efficiently achieve
FDA compliance and ISO conformity.
In fact, the STAT-A-MATRIX 14-step implementation
process is applicable to companies seeking
compliance with the FDA's Medical Device Quality
System Regulation as well as to ISO 13485
registration.
STAT-A-MATRIX has programs and consulting
capabilities to help guide all types of organizations
through the often overwhelming maze of regulatory
compliance and standard certification requirements.
Our highly experienced consultants—most
of whom have been through this process in
the corporate world themselves—understand
and address individual needs within small
and large organizations.
STAT-A-MATRIX works with Fortune 500 companies
to sharpen skills and capabilities, providing
experts in specific subject areas as needed,
as well as to educate and inform their new
employees. Likewise, STAT-A-MATRIX works with
start-up companies to jump-start their programs
and cost-effectively address new initiatives.
FDA's Center for Devices and Radiological
Health (CDRH) has created cross-cutting collaborative
product groups to better integrate Premarket,
post-market and enforcement efforts.
The Center is pursuing the development of
unique identifiers (UDI) for medical devices,
in collaboration with industry and health
care providers, in order to easily identify
specific devices when post-market questions
are raised. CDRH also is considering making
electronic reporting of adverse event data
mandatory ("eMDR").
STAT-A-MATRIX is continually involved in
the development and interpretation of regulations
facing the medical device industry. FDA continually
reviews its programs and annually publishes
new regulatory initiatives and goals based
on its oversight experience and Congressional
input.
Staying linked to STAT-A-MATRIX programs
and consultants is an effective means of staying
on top of the ever-changing regulatory environment.
There are several changes to FDA's inspection
approach. One important area for device manufacturers
to better understand is the quality system
inspection technique (QSIT) for evaluating
device manufacturers’ compliance.
QSIT is a “top-down” approach
that focuses on key control elements or subsystems
of the regulations, including management controls,
design controls, corrective and preventive
actions (CAPA), and process controls. Understanding
this inspectional technique can help you determine
the best approach to compliance for your organization.
STAT-A-MATRIX has the experience and resources
to guide you in this area.
Awareness is growing in the medical device
industry that organizations not only need
to know how to comply with regulations and
standards, but how to integrate the regulations
and standards into value -added business processes.
To that end, STAT-A-MATRIX provides guidance
in designing customized processes and compliance
pathways, which support your business goals.
For instance, we emphasize process models
that link the compliance/conformance needs
with business activity-interface management
and control systems.
Another strategy is tying together the various
elements of a robust quality management system
with the methods to monitor, control, and
sustain those elements.
And still another approach is to align problem
solving and project management linked to compliance
activities.
STAT-A-MATRIX offerings are comprehensive
and robust. They include—but are not
limited to—programs in the following
areas:
- FDA’a medical device regulations
- FDA quality system inspection techniques
- Process and software validation
- Risk management and analysis
- Design control and management
- ISO 13485 Implementation
- ISO 13485 and ISO 9001 internal and leader
auditor certification training
- CAPA (Corrective Action/Preventive Action)
for the medical device industry
Customized consulting services, auditing and
documentation review, are also available to
meet the specific needs of your organization.
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