“Device to market is KNOWING WHERE TO BEGIN…”
The MedCepts Medical Sales & Marketing Network is a diversified network of individuals and companies with experience from the “New Idea to Concept” and Distribution
Below are a few FDA and USPTO (US Patent/Trademark) resources
- Premarket Regulations:
- Is The Product A Medical Device?
- Is My Product Regulated by FDA’s Center for Devices and Radiological Health?
- Classify Your Medical Device
- IDE Overview – “An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA.”
Medical Device Regulations
- Radiation Emitting Products – Does The Product Emit Radiation?
- FDA CDRH Forms
- Center for Biologics Evaluation and Research (CBER)
- Centers for Medicare & Medicaid Services (CMS)
- Devices Approved by FDA – Search databases on the CDRH (FDA) website containing both 510(k) and PMA information.
Explore Our Network at MedCepts – See Medical Product Development and Launch Service Providers – From the new idea to concept for specialists in this area.