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ISOplan USA is specialized in FDA 510k consulting and can assist you with:

Traditional FDA 510(k) Approval Process

Most Class II medical devices and a small number of Class I and Class III medical devices must undergo this process in order to obtain FDA approval to be sold in the US market. ISOplan can assist you in submitting a successful application for you device or IVD (In Vitro Diagnostics).

Abbreviated 510k Clearance Process

This submission type relies on the use of summary reports which demonstrate your use of special controls or Declarations of Conformity to recognized standards and guidance documents. Your medical device or IVD might qualify for this type of submission submission if: special controls have been established, you have followed FDA Recognized Consensus Standards, FDA guidance documention exists. ISOplan can assist your company preparing a successful application.

Special 510(k) Approval Process

This type of submission is appropriate for a modification to a medical device that already has FDA clearance to market. Our specialists will evaluate each modification against specific criteria to make sure the modifications do not affect either the intended use or alter the scientific technology of your medical device.

How to Determine Substantial Equivalence to a Predicate Device

ISOplan USA can help you determine if your medical device is substantially equivalent to another medical device (predicate device) legally marketed in the USA and if a 510k submission is appropriate for your case. Our specialists can also help you finding predicate devices similar to your medical device or IVD.

FDA Medical Device Registration Consulting

ISOplan USA provides FDA Medical Device Registration Consulting to help you determine how FDA classifies your medical device. Our specialists will help you classify you medical device as a Class I, Class II or Class III medical device.

FDA Software Guidance for FDA Software Validation

ISOplan USA provides FDA Software Guidance for FDA Software Validation. Our FDA consultants can assist you with your medical device software validation and compliance to FDA Software Regulations. If your medical device is software controlled our FDA consultants will evaluate your existing documentation and eventually suggest any actions that may be required in order to comply with FDA Software Regulations.

Why you need to choose us as your FDA 510k consultants?

ISOplan USA have successfully prepared submissions for medical device and IVD (In Vitro Diagnostics) companies worldwide. Our approach is the most efficient and cost effective, since it dramatically increases the probability of a successful submission.