EAS Consulting Group, LLC (EAS) can make recommendations and provide assistance with FDA submissions for your product(s). With scientific experts in toxicology, radiology, chemistry and biology and authorities in FDA laws and regulations, EAS’ consultants can lead your company through the process of obtaining necessary background data, filing the submissions, and following-up as needed during the submission process.
- Premarket Notifications or 510(k) Submissions: Premarket Notification (510(k)) submissions for medical devices are required by FDA to ensure that products are safe for use. They are reviewed by, the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostics and Radiological Health (OIR) which fall under the CDRH.
- De Novo Applications: De Novo applications offer an expedited pathway to approval for class I and class II products for which there is no currently approved predicate.
- Investigational Device Exemptions (IDE): An IDE allows an investigational device to be used in a clinical study to determine its safety and effectiveness, often in support of a PMA. Once an IDE is approved, the device can be shipped for use in the trials without the other requirements for medical devices as specified in the FD&C.
- Premarket Approvals (PMA): A Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, that support or sustain life. It is the most stringent of device marketing requirements by FDA.