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510(k) Premarket Notifications
The primary mechanism by which new medical
devices come to market in the United States
is through the 510(k) process. A 510(k) is a
premarketing submission made to FDA to
demonstrate that the device to be marketed
is as safe and effective, that is,
substantially equivalent, to a legally
marketed device. Applicants must compare
their device to one or more similar devices
currently on the U.S. market and make and
support their substantial equivalency
claims. Most devices, excluding the most
novel or most complex technologies, are able
to utilize this process which requires
submission of descriptive data, and possibly
performance data, in a 510(k) application.
FDA’s review time for a 510(k) is 90 days
and frequently a clearance
can be received shortly thereafter.
O'Connell Regulatory Consultants has
significant expertise in filing successful
510(k) applications for diagnostic and
therapeutic Class II products in
ophthalmology, dermatology, plastic surgery,
vascular surgery, wound care, and other
specialties.
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PMA Submissions
The most novel and most complex technologies
are classified by FDA as Class III devices
which require approval through the Premarket
Approval (PMA) process prior to entering the
U.S. market. Premarket approval is the FDA
process of scientific and regulatory review
to evaluate the safety and effectiveness of
Class III medical devices. Class III devices
are those that support or sustain human
life, are of importance in preventing
impairment of human health, or which present
a potential, unreasonable risk of illness or
injury. PMA is the most stringent type of
device marketing application required by
FDA. The applicant must receive FDA approval
of its PMA application prior to marketing
the device.
PMA approval is based on a determination by
FDA that the PMA contains sufficient valid
scientific evidence to assure that the
device is safe and effective for its
intended use(s).
This is a rigorous process and FDA’s review time is usually a
minimum of 180 days. O’Connell Regulatory
Consultants, Inc. has significant expertise
in submission of Premarket Approval
applications.
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PMA Supplements for additional clinical indications or device changes
Once a Class III device has been approved by
FDA through the Premarket Approval process,
any device changes or new clinical
indications are highly regulated by FDA and
must be approved by FDA through a Premarket
Approval Supplement application.
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Investigational
Device Exemptions (IDEs) for clinical trials
New medical devices generally cannot be used
in human subjects without approval from the
FDA and an Institutional Review Board (IRB).
The application which is filed with FDA
seeking this approval is called an
Investigational Device Exemption (IDE)
application.
An IDE allows the investigational device to
be used in a clinical study in order to
collect safety and effectiveness data
required to support a Premarket Approval (PMA)
application or a Premarket Notification
[510(k)] submission to FDA.
FDA reviews this type of application in 30
days and after an IDE has been approved by
FDA and subsequently an IRB, the device may
be used in human subjects.
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Combination Product Device Trials and Approvals
Many new medical products utilize a
combination of drug and device technology.
These products are regulated by a new office
at FDA which specializes in these highly
complex products. O’Connell Regulatory
Consultants has experience with the types of
submissions necessary to pursue approval for
a combination drug/device.
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Managing Significant Risk and Non-Significant Risk Device Trials
Clinical trials can be either significant risk
or non-significant depending upon the level
of risk to the subject. O’Connell Regulatory
Consultants can help you determine which
type of device trial your device would be
subject to based on the specific
characteristics of your device and the types
of treatments to be performed. Certain
non-significant risk device trials can be
performed based on approval of an IRB
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Clinical Site Training and Monitoring
One of the most important aspects of any
medical device clinical trial is the
training and monitoring of clinical sites.
O’Connell Regulatory Consultants has years
of experience working productively with the
staff at clinical sites.
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Labeling and Advertising Reviews
Once medical devices are approved to be
marketed in the United States, it is
critical that all advertising and promotion
of the device be performed within the
approved device labeling. A rigorous review
of all proposed labeling should be performed
prior to introduction of new advertisements
or promotions.
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Company Registration and Device Listing
Prior to introduction of medical devices
into the United States market, companies
need to register their Establishment with
FDA using FDA 2891 and notify FDA of the
types of devices that will be entering the
United States market by completing Device
Listing using FDA 2892.
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CDRH
Electronic Product and Laser Reporting
Certain electronic and radiation emitting
products require an additional level of
reporting prior to introduction into the
U.S. market beyond 510(k) or PMA submission.
Reporting regarding certain aspects of
safety is required to the Center for Devices
and Radiological Health.
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Compliance and Custom Problems
There are a number of circumstances that can
lead to unwanted compliance and customs
problems. O’Connell Regulatory Consultants
can assist you in resolving any issues as
expeditiously as possible.
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The consultancy has managed all phases of
clinical studies and prepared regulatory submissions required to
obtain FDA marketing approval including IDEs, 510(k)s, and PMAs.
Activities also include establishment registration and listing;
preparation of all clinical study materials including protocols,
informed consent forms, case report forms, and patient education
materials; study-related site training and site monitoring;
interfacing with clinical investigators, Institutional Review
Boards and the Food and Drug Administration; and supervision of
data collection, data entry, and data analysis. We have also
provided project management for all aspects of PMA submissions
including timeline preparation, providing comprehensive advice
regarding technical documentation requirements, writing of
technical and clinical sections, and submission of documents to
FDA. |
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