An Abbreviated FDA 510(k) relies on the use of summary reports which demonstrate your use of special controls or Declarations of Conformity to recognized standards and guidance documents to expedite FDA review of your 510(k) submission.
ISOplan USA can help you in the decision if an Abbreviated FDA 510(k) submission is appropriate for your medical device or IVD (In Vitro Diagnostics).
Your medical device or IVD (In Vitro Diagnostics) might qualify for an Abbreviated 510(k) submission if:
- Special controls have been established
- You have followed FDA Recognized Consensus Standards
- FDA guidance documention exists
ISOplan USA can assist your medical device company in the assesment whether your device is conformant to FDA guidance documents and/or special controls. Our FDA 510(k) consultants can help you to prepare declarations of conformity to recognized standards and prepare the required documentation for your Abbreviated FDA 510(k) submission.
For further information about the FDA 510(k) Approval Process please check the following links:
- FDA 510(k) Clearance Consulting for Medical Devices
- Traditional FDA 510(k) for Medical Devices and IVD’s (In Vitro Diagnostics)
- Special FDA 510(k) Approval Process for Medical Devices and IVD (In Vitro Diagnostics)
- List of Medical Devices Exempt from the FDA 510(k) Procedure
- How to Determine if a Medical Device is Substantially Equivalent (SE) to a Predicate Device for an FDA 510(k) Clearance Process