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).

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.

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.

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.

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.

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.