European medical device manufacturers for Rome, Italy looking to market their products in the United States must first understand the differences in regulatory compliance requirements here compared to the European market. To ensure the most favorable outcome it is important to partner with an experienced medical device consulting firm such as MEDIcept that can help you establish a regulatory strategy, assist with quality management, and provide clinical research consulting.
As a medical regulatory and compliance consulting firm specializing in FDA medical device consulting, MEDIcept is uniquely positioned to act as a US agent and assist European companies in Rome, Italy looking to enter the US medical device market. We can help you with the four major steps necessary to bring a device to market:
- Classifying your device and helping you comply with a regulatory strategy
- Selecting and preparing the correct premarket submission
- Working on the clinical trial management
- Sending your premarket submission to the FDA and interacting with FDA staff during review
- Complying with applicable regulatory controls including the establishment registration and device listing
The first step in preparing a Rome, Italy device for marketing in the United States is to determine how the FDA has classified your device. A medical device is defined by law in section 201(h) of the Federal Food, Drug and Cosmetic (FD&C) Act.
Medical devices in the United States are categorized into one of three classes (I, II, or III), based on the degree of risk they present. As device class increases from class I to class II to class III, the regulatory controls also increase, with class I devices subject to the least regulatory control, and class III devices subject to the most stringent regulatory control.
Based on the classification and the regulatory strategy, you must determine if a clinical trial is necessary. Clinical development, clinical trial design, protocol development, and choosing the right CRO Services are very important first steps for a successful clinical trial. If the clinical coordinator and site management are not experienced, the data management will not show you what you need.
Once your device has been classified, as your Rome, Italy medical device consulting partner, we can act as your US agent and help with your regulatory strategy and prepare the appropriate premarket submission, if one is required for your specific device. For most medical devices, the appropriate submission type is identified within the product classification, which may be obtained from the Product Classification database.
After the appropriate premarket submission has been selected and prepared, it must be submitted to the FDA for review. It’s important to know that your company must be prepared to interact with the FDA review staff and respond to any and all inquiries. At MEDIcept, we can assist companies like yours for Rome, Italy with responses and provide any necessary medical device consulting needed to successfully address any questions raised by the FDA.
The fourth step is complying with any applicable regulatory controls, which are risk-based requirements that apply to medical devices and give FDA the oversight to ensure the reasonable safety and effectiveness of medical devices. Devices in all three classes are subject to general controls, unless exempted by regulations.
Medical device facilities are required to:
- register their establishments and list the medical devices they market with FDA
- manufacture their devices in accordance with the FDA’s Quality System Regulation
- label their devices in accordance with regulations and ensure they are not adulterated or misbranded
This is just a brief overview of how to prepare a Rome, Italy medical device for marketing in the United States. To learn more about how MEDIcept can provide the necessary medical device consulting to help ensure your successful entry into the US market, contact us today.