Medical Devices FDA Essay

Magnetic Resonance division designs, manufactures, and installs MRI systems and
associated equipment for the worldwide medical diagnostic imaging market. In
addition, Marconi MR imports MRI systems from Nordstar (located in Helsinki,
Finland) and installs them in the United States. Associated equipment includes
surface coils and physician viewing stations. Surface coils are specialized
transducers, which, when used with an MRI machine, produce high-quality images
of specific portions of the anatomy. MR designs, manufactures, and installs
surface coils as well. Marconi Medical Systems as a whole, is a transnational
corporation. While retaining its strength in the United Stated, MR’s products
have achieved global recognition. Strengths in markets such as Europe and South
America have opened doors to Asian countries such as Japan and China. MR has a
variety of customers, but focuses primarily on hospitals and imaging centers. MR
customers expect high quality systems that are easy to use, have low operating
cost, high throughput, and can support new technology. An MR system must provide
superior image quality and offer a range of imaging techniques to support
diagnosis. Given the high cost of the equipment ($900,000 on average), customers
expect smoothly installed, easy to operate, reliable, low maintenance equipment
that provides a solid return on investment. To make all this possible, Marconi
must pass the Food and Drug Administration’s (FDA) stringent policies and
procedures for the safe and effective use of a medical device. Advantages of MRI
Unlike x-ray based medical diagnostic techniques such as computed tomography,
magnetic resonance imaging (MRI) and spectroscopy are techniques that do not
employ ionizing radiation. As such, it is considered to be less hazardous than
other x-ray imaging techniques. In addition, since x-rays can only discriminate
different tissues by electron density, which does not vary greatly between soft
tissues, the injection of contrast media is often necessary. In MRI, however,
there are a number of tissue specific parameters which can affect magnetic
resonance (MR) signals. One of the most important advantages of MRI is its
capacity for displaying soft tissue contrast. An example of this capacity is the
discrimination between the gray and white matter of the brain that can be
accomplished with MRI. Image contrast can be tailored to the specific clinical
application so that specific types of pathology are emphasized. In addition,
since MRI is unobstructed by bone, it is especially beneficial in imaging of the
brain and spinal cord. MRI also has the unique ability to acquire images in
numerous planes without repositioning the patient. Three-dimensional recreations
of anatomic structure can be obtained. These characteristics render MRI a very
effective and important tool for soft tissue imaging. Regulations Products
meeting the definition of a device under the Federal Food, Drug and Cosmetic Act
(FD&C Act or “the Act”) are regulated by the Food and Drug
Administration (FDA). Medical devices are subject to general controls and other
controls in the FD&C Act. General controls of the FD&C Act are the
baseline requirements that apply to all medical device manufacturers. Unless
specifically exempted, medical devices must be properly labeled and packaged, be
cleared for marketing by the FDA, meet their labeling claims, and be
manufactured under Good Manufacturing Practices (GMP), which is a mandated
quality assurance system. FDA regulates devices to assure their safety and
effectiveness. To fulfill provisions of the FD&C Act, FDA develops rules to
regulate devices intended for human use. These rules regulate various aspects of
the design, clinical evaluation, manufacturing, packaging, labeling, commercial
distribution, and postmarket surveillance of devices. These regulations are
published in the Federal Register. Final regulations are codified annually in
the Code of Federal Regulations (CFR). What is a Medical Device? The definition
of a device appears in section 201(h) of the FD&C Act. A device is:
“…an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including a component, part,
or accessory, which is: ? recognized in the official National Formulary,
or the United States Pharmacopeia, or any supplement to them, ? intended
for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
? intended to affect the structure or any function of the body of man or
other animals, and which does not achieve any of its primary intended purposes
through chemical action within or on the body of man or other animals and which
is not dependent upon being metabolized for the achievement of any of its
primary intended purposes…” Accessories and Components Certain components
such as blood tubing sets, major diagnostic x-ray components, and stand-alone
software are regulated by the FDA as finished devices because they are
accessories to finished devices and meet the above definition of a device.

Software that is to be marketed to enhance the performance of a device is
regulated as an accessory to that device. Software that enhances the performance
of a group of different devices is regulated as an accessory to the device that
poses the greatest risk to the patient. The manufacturer of accessories is
subject to the medical device regulations when the accessory is labeled and
marketed separately from the primary device for a health-related purpose to a
hospital, physician, or other end user. So, you want to sell a medical device?
Each manufacturer who wants to market medical device intended for human use in
the U.S. must submit a 510(k) (premarket notification) to FDA at least 90 days
before marketing unless the device is exempt from 510(k) requirements. 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 that is not subject to premarket approval. Premarket
approval (PMA) is the most stringent type of device marketing application
required by FDA. A PMA is an application submitted to FDA to request clearance
to market, or to continue marketing the medical device. Unlike premarket
notification, PMA approval is to be based on a determination by FDA that the PMA
contains sufficient valid scientific evidence that provides reasonable assurance
that the device is safe and effective for its intended use or uses. In the first
stage of the design process, the Product team, with the assistance of the
Regulatory Affairs team, determines the regulatory requirements for a product.

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One of the key requirements that must be considered is if a 510(k) submission is
required in order to distribute the product in the United States. The product
team leader completes a Regulatory Impact Assessment (RIA) to determine if such
a submission is needed. After completing the product information required by the
RIA, the Product Team Leader submits the information to the Regulatory Affairs
section to determine whether the new product requires a 510(k). If Regulatory
determines that a 510(k) submission is needed for one or more features included
in the product, the Product Team Leader should incorporate the submission
strategy into the design plan for the product. The strategy should include both
the number of submissions required for the product (individual features may be
submitted separately) and the type of submission to be filed for each feature.

Based on the type of feature/product and the needs of the business, the
Regulatory group may recommend one of the four types of 510(k) submissions.

? Special 510(k): This type of a submission can be used in cases where
there is no change in the intended use of the device or in the fundamental
scientific technology of the device. Instead of submitting data to support the
submission, the manufacturer submits a “Declaration of Conformity”
with the design control requirements in the Quality System Regulations and a
brief summary of their design control process. All design control activities and
verification/validation tests specified in the Risk Analysis must be completed
at the time of the submission. The advantage of this type of submission is that
FDA will make a clearance decision in 30 days. ? Abbreviated 510(k): This
type of a submission can be used in cases where there is a device-specific
guidance document or FDA has recognized a relevant consensus standard. Instead
of submitting data to support the submission, the manufacturer submits a
“Declaration of Conformity” to the recognized standard and a brief
summary of the activities taken to meet that standard. All activities required
by the recognized standard must be completed at the time of the submission FDA
does not guarantee a shorter review time with this type of submission, but they
believe review times should be shorter. ? Traditional 510(k): This type
of a submission can be used in all cases These submissions can contain
promissory notes on activities that will be done prior to commercial
distribution, but have not necessarily been completed at the time of the
submission. FDA is supposed to give a clearance decision for the submission in
90 days. Note: if they formally request (i.e. in writing) additional
information, the review time clock starts over at zero once that information is
submitted. ? Third-Party Reviewed 510(k) ? These submissions are
similar to traditional 510(k) submissions. However, the initial review is
conducted by a qualified third party at a predetermined expense. Once the third
party completes the review, the submission is forwarded to FDA for final review
and clearance. Although there is a cost involved with this submission, the
review time is typically shorter (30-45 days) since they bypass the queue of
submissions at FDA. The Regulatory Affairs Group prepares and submits all
documentation required for FDA approval/clearance of new products and
modifications/ upgrades to existing products. The team is responsible for all
interactions with government regulatory agencies and Industry Relations
(Corporate) Department. It also monitors and follows-up Medical Device Reporting
(MDR) requirements and monitors compliance with the Safe Medical Devices Act and
other medical device legislation. When a manufacturer decides to modify an
existing device, they must decide whether the proposed device modification
requires submission of a 510(k). It is not FDA’s intent that a 510(k) must be
submitted for every modification. However, all changes in indications for use
require the submission of a 510(k). Examples of modifications that may require a
510(k) submission include the following: ? Sterilization method ?
Structural material ? Manufacturing method ? Operating parameters
or conditions for use ? Patient or user safety features ? Sterile
barrier packaging material ? Stability or expiration claims ?
Design FDA believes that the manufacturer is best qualified to determine when
modifications to their device could significantly affect safety or
effectiveness. Therefore, every modification to the device should be reviewed by
appropriate personnel to determine if it affects safety or efficacy. If it is
determined that the modification is not significant, the basis for this decision
should be documented with supporting data in the manufacturer’s device master
file. If it is determined that the modification is significant, then a complete
510(k) must be submitted to FDA. If FDA finds the device to be substantially
equivalent, FDA will send the manufacturer a marketing clearance letter,
referred to as an “SE letter”, and the device may be marketed as
described in the 510(k). If FDA finds the device not to be substantially
equivalent, FDA will send a not-substantially equivalent letter. In the latter
instance, the manufacturer may chose to resubmit another 510(k) with new
information, may petition FDA requesting the device be reclassified or may
submit a PMA. Manufacturers may not place their device into U.S. commerce until
they receive a marketing clearance letter from FDA. Once they receive the
approval letter, they can then sell the product to the U.S. market. In addition,
before clearance is obtained the manufacturer must assure that the device is
properly labeled in accordance with FDA’s labeling regulations. Once clearance
for marketing is obtained, the manufacturer must register their establishment
and list the type of device they plan to market with the FDA. Finally, once on
the market, there are postmarket surveillance controls that a manufacturer must
comply with; these include the Quality Systems and Medical Device Reporting (MDR)
regulations. The QS regulation is a quality assurance requirement that covers
the design, packaging, labeling and manufacturing of a medical device. The MDR
regulation provides a mechanism for FDA and manufacturers to identify and
monitor significant adverse events involving medical devices. The goals of the
regulation are to detect and correct problems in a timely manner. Although the
requirements of the regulation can be enforced through legal sanctions
authorized by the Federal Food Drug and Cosmetic Act, FDA relies on the goodwill
and cooperation of all affected groups to accomplish the objectives of the
regulation. Analysis The medical device industry tends to comply with all
government regulations to get the product to market. The more time it takes to
get the product to market, the less money the business makes. Many laws tend to
be vague and are subject to interpretation. The problem for medical device
manufacturers is that many of the laws are broad and written for drugs and not
for medical devices. As a consumer, the FDA is an excellent regulatory body to
have around. For an industry however, it can be very difficult to get through
all the red tape. Entire regulatory departments are needed just so the necessary
paperwork can be generated for market approval. The FDA does recognize that
through constant modification to the existing laws, and assisting the medical
device industry in obtaining market approvals, together industry and government
can work together to improve healthcare for the general public.

1. Marconi Medical Systems, Inc. MR GBC Work Instruction MR 313. 2. Duane
Praschan, former Regulatory Affairs manager, Marconi Medical Systems. 3.


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