Medical Devices and IVDs (US)
HTC members have decades of experience preparing and submitting hundreds of Product Submissions for Medical Devices.
Investigational Device Exemption (IDE)
When clinical data is necessary for your product, we can prepare and submit your IDE (and if you are a non-US manufacturer/sponsor, we can provide the FDA required Agent or Attorney services).
Premarket Notification (also known as the 510(k))
Getting to market in the US can be made easier by working with an HTC member that has been responsible for getting products like yours to market in the least amount of time. Strategic planning is essential here and our partnering with you can be the factor that gets you to market faster.
Premarket Approval Application (PMA)
A PMA is generally needed for a device that has no identifiable predicate product. This type of submission will normally need to include a clinical study (approved by an IDE for significant risk devices).
Product Development Protocol (PDP)
A PDP in simple terms is a PMA where there is early communications and agreement with the FDA as to what will be needed to demonstrate the required safety and effectiveness of your new device.
The PDP is a contract between the manufacturer and the FDA that includes design and development activities and establishes reporting milestones. Once the PDP is declared completed by the FDA, the sponsor has an approved PMA.
Humanitarian Device Exemption (HDE)/Humanitarian Use Device (HUD)
A HUD approved device is limted treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A HDE is submitted for review by FDA's Center for Devices and Radiological Health. This submission is similar to that of a PMA but does not require the results of scientifically valid clinical efficacy testing for approval. A number of special conditions apply to this type of product. 1) A HDE application must include risk / benefit information, 2) no comparable device is available and that the developer counld not otherwise bring the device to market and 3) use is limited to facilties that have an established institutional review board (IRB or EC) to approve the use of the device.
If this specialized type of product submission could be of interest to you, please contact us to discuss your specific situation.
HTC can also prepare and submit Requests for Classification for your company's new device (FD&CA Section 513(g)) or a Request for Determination for your combination product.
Medical Device and IVD (EU)
Whatever Class of product you manufacture, HTC is prepared to support your needs in the European Union and elsewhere in Europe.
Are you prepared for the March roll-out of the new requirements for medical devices? We can help you though the new annual Technical File review requirements for yours products.
Are your prepard for the new requirements for Clinical Data? We can help you through the process.
Medical Devices and IVD (Canada)
Making the move to Canadian Distribution? Let us help you extend your market reach seamlessly.