PROSYSTEM offers diverse services for the successful US market approval of your medical device. Among others, we can assist you with:

For further details about US Market Regulatory Affairs or a non-binding quotation, don’t hesitate to contact us.

US Agent Search

The Food and Drug Administration demands from all medical device manufacturers outside the USA to name a US-Agent located in the United States.
The US-Agent is the first point of contact for the FDA, if the medical device manufacturer is not reachable for the FDA in first place.
PROSYSTEM supports you in your search for an adequate US-Agent for your company.

Registration and Listing

PROSYSTEM guides you through the FDA Registration of your production sites and lists your devices intended for marketing in the United States.
All companies involved in the production or delivery of medical devices, intended for marketing in the USA, have to register their production sites. All devices marketed in the US have to be listed in the FDA database.
PROSYSTEM supports you during registration and listing of your sites and products.

FDA 513(g) Klassifizierung von Medizinprodukten

There are situations where uncommon medical devices are difficult to classify and where their classification and submission strategy should be verified by the FDA.
PROSYSTEM accomplishes all steps to get a classification for your device. Based on the description of the device we set up a request to obtain an official classification ruling from FDA.
PROSYSTEM will help to set up and write the relevant documents, set up the product description and communicate with FDA on your behalf.
Use our long lasting experience with FDA and let us help you to reach your goals faster and more efficient.

FDA 510(k) Clearance for Medical Devices

Medical device manufacturers of class II medical devices, which want to legally market their products in the US, necessiate an FDA-clearence for their devices. This process is a submission of documentation according to chapter 510(k) of the Federal Food, Drug, and Cosmetic Act, which allows FDA to determine if the medical device is substential equivalent to already legally marketed predicate devices in the US. Is the evidence of substencial equivalence not obvious to the FDA, the manufacturer might need to obtain a PMA approval instead.
Not only marketing a new product in the US, but also changing an existing design of a marketed device might lead to a new 510(k). Further development of the product portfolio should therefore always be performed in close collaboration with regulatory affairs professionals.

PROSYSTEM offers a comprehensive package for the compilation and submission of your 510(k):

  • Analysis of the respective medical device for classification and identification of the regulation number
  • Listing of all documents required for a 510(k)
  • Identification of one or more predicate devices
  • Analysis of all relevant FDA Guidelines
  • Preparation of all relevant chapters of the 510(k)
  • Coordination of FDA response
  • Support of the 510(k) submission fee payment process
  • If you currently do not have legally marketed devices in the US we support you with your Registration and Listing.

FDA Premarket Approval (PMA) for Class III Medical Devices

The applicant must receive FDA approval of its PMA application prior to marketing the device. The FDA bases a PMA approval on a determination that the submission contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use.
The PMA application is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the class III device. There are administrative elements of a PMA application, but good science and scientific writing is a key to the approval of the PMA application.

A PMA normally comprises the following information:

  • Device Decription
  • Intended Use
  • Principles of Operation
  • Properties of the Device
  • Results of Non-Clinical Studies
  • Quality Controls
  • Clinical Data

PROSYSTEM supports you during the entire PMA process:

  • Development of a Submission Strategy
  • Development of a Project Plan
  • Identification of required Information
  • Preparation and monitoring of clinical trials
  • Compilation of the PMA Documentation
  • Communication with the FDA during the Application Phase
  • Preparation of the FDA Meetings
  • Benefit from our experience in numerous PMA-Projects.

FDA Investigational Device Exemption (IDE)

An IDE is required to perform clinical studies in the USA. Safety and efficacy of the product have to be proven, while no other regulatory requirements have to be fulfilled. All clinical studies require an approved IDE before starting clinical tests.
There are two ways to get an IDE

  • An IRB (Institutional Review Board) verifies the documentation and approves the study – for ‘non-significant-risk-devices’
  • The applicant conveys its documentation to FDA and IRB. Both of them verify the documentation and approve the study. –for ‘significant-risk-devices’

PROSYSTEM issues relevant documentations with your collaboration. This includes study plan, technical documentation, risk-benefit analysis, and a report about previous studies.