MEDICAL DEVICE ESTABLISHMENT REGISTRATION AND DEVICE LISTING
Companies who are involved in manufacturing, testing, packing, labeling, sterilization or import of medical devices are required to register their facility, pay FDA registration fees, and list their devices with the FDA. FDAbasics offers FDA medical device registration and listing services at competitive fees....Read More
PRE MARKET NOTIFICATION 510 (K)
Some Class I and most Class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed.
We provide complete assistance for Pre-Market Notification 510(k), at highly competitive fees. Please contact us for more information.
PMA (PREMARKET APPROVAL)
Most Class III devices require Pre-Market Approval, or PMA. The PMA is the most stringent type of pre-market submission. We provide complete assistance for Pre-Market Approval at highly competitive fees....Read More
HDE (Humanitarian Device Exemption)
Humanitarian Device Exemption – or HDE – provides a regulatory path for Class III devices that are intended to benefit patients with rare diseases or conditions. If you are looking for any further assistance for HDE, Pragmatic can help....Read More
INVESTIGATIONAL DEVICE EXEMPTION (IDE)
An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study to collect safety and effectiveness data, which can be required for Pre-Market Approval applications or a Pre-Market Notification. We provide support for IDE....Read More
DE NOVO SUBMISSION
De Novo provides a way for a new device, without a valid predicate, to be classified into Class I or II if it meets certain criteria. Pragmatic can help you with the preparation of your De Novo submission....Read More