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Arazy Group Home » FDA Clearance
 
 
How to Get FDA Clearance
 
In order to get FDA clearance for you product, you need to comply with one or more of the following requirements:
  • Establish and maintain a Medical Quality Management System, which complies with the GMP/QSR requirements

  • Construct and submit an product clearance application file (510(k) or a PMA) file

  • Contract a Regulatory Designated Agent in the EEUU

  • Register your company with the FDA

  • List your products with the FDA files
The actual requirements your product will need to comply with are subjected to the classification of your devices. This classification is based on the risk level established in Title 21 of the Code of Federal Regulations (CFR) - FDA, Parts 862-892.

Here are some examples of medical devices and there correlation to product classification classifications:


Description
CE Classification
Anesthesia machines
II
Bioactive implantable devices
II
Blood oxygen analyzers
II
Bone cements, with antibiotic
II
Brachytherapy devices
II
Catheters, angioplasty balloon
III
Catheters, with radioisotopes
III
Collagen implants
III
Condoms
II
Contact lenses
II
Contraceptive intrauterine devices (IUDs)
III
Corrective glasses
I
Crowns
I
Defibrillators, external
III
EEG and EMG Electrodes, non-invasive
I
Electrodes, neurocortical
II
Examination gloves
I
Extracorporeal Circulation Devices
II
Hemodyalizers.
II
Hospital beds
I
Incubators for babies
II
Infusion cannula
I
Infusion pumps
II
Lenses, intra-ocular
III
Lithotriptors
II
Lung ventilators
II
Muscle stimulators
II
Nebulizers
I
Needles, for syringes
I
Prosthetic heart valves
III
Scalpels
I
Shunts, carotid artery
III
Sterilizers for medical devices
II
Stethoscopes for diagnosis
I
Stomach pumping tubes
I
Stretchers
II
Sutures, absorbable
II
Syringes without needles
II
Ultrasound diagnostic equipment
II
Vascular stents
III
Wheelchairs
I
More examples…
 
 


If any of these examples is equal or similar to your type of products, take note of its classification and click on the corresponding red button. If you are not sure, just click on the “Tell us what you need” button, and let us do the work for you.
Arazy Group – US Medical Device Regulation – FDA approval – Class III – PMA submission
Arazy Group – Medical Device Regulation - What is CE mark and FDA approval? – FAQs
Arazy Group – Medical Device Regulation – Online Products
 
 
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