FDA classify Medical Devices and how to report device problems A Systematic Review – Pubrica
                     FDA classify 
Medical  Devices 
and how to  report 
device problems:  A 
SystemaAntAciacdem iRc peresvenitaetiown by 
 Dr. NancyAgnes,Head, Technical Operations,
Pubrica
Group:
www.pubrica.com  Email:
[email protected]
Today's 
OInu brief  Introdtucltiione
n
The Pre-Clinical Stages: Prototype Development 
and  Testing
Basic Pathways to Medical Device 
Approval  Conclusion
About Pubrica
In 
bInr niewe mfedications, the FDA's clearance procedure 
is  designed to provide consumers confidence that a  
 medical device will be safe and effective in its  
intended use once it comes to market.
The typical time it takes to get a  device to market is 
3  to 7 years, compared to 12 years for 
pharmaceuticals.
However, there are concerns that the Food and Drug Administration's  S
ystematic Review Writing methods may not be adequate to satisfy the  
required guarantees of safety and efficacy.
This blog aims to review the second part of a  two-part series on the 
essential  phases in medical device development and FDA clearance and 
summarise  post-marketing protocols for pharmaceuticals and devices ( J  
Am Coll Cardiol  Basic Trans Science 1:277–87, 2016). The Authors, 2016. 
Elsevier represents the  American College of Cardiology Foundation.
The second part of a  two-part series discusses the fundamental phases in  
medical device development and FDA clearance and the post-marketing  
processes for medications and devices.

Introducti
oThne FDA's Center for Devices and Radiological Health (CDRH) oversees  
device regulation.
A device is defined as "an apparatus, instrument, contrivance, 
implement,  machine, implant, or in vitro reagent" that meets three 
criteria: 1) it is  recognised in the official National Formulary or the United 
States  Pharmacopeia; 2) it is intended for use in the diagnosis of 
disease or other  conditions, or the cure, mitigation, treatment, or 
prevention of disease; or 3)  it is intended to affect the structure or utility 
of the human body.
Devices cannot achieve their goals by chemical action or by 
metabolism.  Some biologically based products are inert (e.g., acellular 
dermatologic  fillers) and classified as devices.
According to the FDA, medical devices include tongue depressors,  
stethoscopes, lab equipment, surgical tools, and life-support equipment,  
including pacemakers, ventilators, and perfusion systems.
If a  product is a  device or a  biological, the FDA's Device Determination  
Officer can help.
Another component of an informative abstract is the presentation of  
unbiased information. Abstracts are frequently read since these are  
provided by indexing/abstracting services and are placed at the  
beginning of the articles.
The abundance of published materials competing with the finite amount 
of  time available to stay current with the literature may force many  
practitioners to resort to reading only the article abstract.
The Pre-Clinical Stages: 
Prototype  Development and 
Testing
Many of the new medical gadgets on the market are 
adaptations of prior  equipment.
A physician or bioengineer's proposal for a  remedy to a  medical 
condition  is usually the starting point for developing an altogether new 
device.
In Conducting a Systematic Review, they create or arrange to construct 
a   preliminary prototype of the device while also starting the patent  
procedure.
Animal testing follows initial bench testing, and the device then enters 
a  testing and redesign cycle that takes 2 to 3 years and costs between 
$10  million and $20 million.
Because of these expenditures, venture-backed startup firms rather than 
 university medical institutes now produce the majority of really novel  
medical devices.
Basic Pathways to  
Medical Device 
ADpepepndrinog vona tlhe type of the item and 
the  conditions under which approval is  
requested, there are 3 main stages for  
obtaining FDA marketing clearance for  
medical devices: Three processes are: 1)  
the PMA, 2) the PMN, and 3) the  
humanitarian device exemption (HDE).
PATHWAY 1: PRE-MARKET APPROVAL (PMA)
Federal law requires device makers to inform the FDA of their intent to  
commercialise a  medical device at least 90 days before release.
The FDA requires a PMA for every new device for which there is no 
existing  equivalent or predicate unless the device can be classed as a 
"de novo"  device.
A device must be proven to have enough scientific Systematic Review  
Service evidence that it is safe and effective in its intended application 
to  receive a PMA.
PATHWAY 2: PRE-MARKETING NOTIFICATION (PMN): THE 510(K) 
APPLICATION
A PMN, also known as a 510(k) application, is a  fast-track process for  
medical devices in which the sponsor demonstrates that the product is  
substantially identical to an authorised and marketed item.
Devices under PMA evaluation but not yet authorised cannot be used 
as a  predicate device in a  PMN for a  separate, new device. A PMA 
application is  not required if the FDA decides that the device has an 
acceptable  predicate, and PMN can proceed.
PATHWAY 3: THE HUMANITARIAN DEVICE EXEMPTION (HDE)
A humanitarian use device (HUD) is a  medical gadget designed to 
treat or  diagnose illnesses that affect less than 4,000 people in the 
United States  each year.
The FDA's Office of Orphan Products Development is in charge of HDE.
In addition to FDA permission, the use of a  HUD needs approval and  
monitoring by a local IRB.
The application for an HDE is similar to that for a  PMA, except that 
scientific  evidence of efficacy is not required, based on the rationale 
that finding  enough subjects to provide sufficient power for a  clinical 
TRreiavli eSwy sStermvaicteics to achieve statistical significance could take 
years.

Devices: post-market  
regulations and 
pIfr ao decveices fuslfiels asn.y of the following requirements, the FDA may compel 
 manufacturers to implement post-marketing surveillance programmes  
and submit a  post-marketing surveillance report.
Its failure would very certainly result in catastrophic health 
effects;  It is predicted that it will be widely used in paediatric 
populations.
It is designed to be a life-sustaining or life-supporting device used 
outside  of a  device user facility, or
It is intended to be implanted in the body for more than one year.
Conclusio
nDrug and device approval processes have a great deal in common. Each  
offers unique pre-submission prospects for FDA engagement. There are 
three  basic routes to approval for each.
A major road (the Investigational New Drug Application and the PMA,  
respectively) requires strong clinical proof of effectiveness and safety and 
a  channel for an emergency usage (the emergency investigational new 
drug  and the Emergency Use notification, respectively).
The investigator faces a series of challenges, the first of which is to 
choose  which path to take. Early and regular engagement with the FDA is 
 recommended to minimise errors and difficulties that waste time and 
money.
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