Consultation about FDA 510 k clearance and submission

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FDA 510K Consultant

• FDA 510k Clearance, Submission and Premarket
  Approval

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What Does a FDA 510( k) Clearance mean?

• Medical devices for human use within the United
  States must be submitted to the FDA to determine
  if the product is safe and effective. To do this,
  in utmost cases a company must compare their
  product to one formerly cleared by the FDA and
  give substantiation that their product is
  substantially equivalent to the preliminarily
  cleared( legally marketed) device. To be mainly
  original, the product must meet criteria for the
  same intended use, have the same technology or(
  slightly) different technology but produces
  similar end results, and be safe and effective.1
  Once pre-market clearance is took from the FDA
  the device can be distributed commercially
  immediately.
• There are important differences between cleared
  and approved . When a medical device is
  cleared, this means it has experienced a 510( k)
  submission, which FDA has reviewed and handed
  clearance. For Class III medical devices to be
  legally marketed they must suffer a rigorous
  review and approval process orpre-market
  approval( PMA)

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What Exactly is Substantial Equivalence?

• In the United States, this frequently means
  submitting a 510( k). A 510( k) is a structured
  package of information about your device and its
  performance and safety that you submit to the
  Food and Drug Administration( FDA) for
  clearance before you can deal your device in
  the U.S. In order to receive clearance from the
  FDA, your 510( k) will need to demonstrate that
  your medical device is substantially equivalent
  to another legally marketed device (called a
  predicate device).
• Now that we know what a 510( k) is, lets talk
  about the substantial equivalence standard. You
  ll recall from the intro that your 510( k) must
  show that the new( or modified) device is
  substantially equivalent to at least one other
  legally marketed device, called a predicate
  device. Substantial equivalence looks at the
  intended use and the technological
  characteristics of the two devices.

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• Operon Strategist is a leading medical device
  consultant providing FDA 510k Clearance process
  consulting to the customers to register SBU(
  Small Business Unit), if applicable. Take out the
  testing demand of the product, creation of the
  dossier, resolving the queries and after
  completion of all the conditioning, the customer
  receives the US FDA 510 k premarket approval. We
  also help with the establishment enrollment and
  device listings to make suitable the supply of
  medical devices in the US.
• We helps during the process of submitting
  operations for class I, II, III medical devices
  at any stages of the product development. Our
  team of good experts will successfully prepare
  and submit FDA medical device regulatory
  documents for theU.S and international customers.

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Operon Strategist
For more information about Medical Device
Regulations please feel free to contact
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