Companies that design, manufacture, repackage, relabel, and/or import medical devices into the United States are regulated by FDA’s Center for Devices and Radiological Health (CDRH). When FDA review is needed prior to marketing a medical device, FDA will either:
“clear” the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or
“approve” the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.
Whether a 510(k) or a PMA application needs to be filed depends on the classification of the medical device.
To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is “substantially equivalent” to a device that is already legally marketed for the same use.
To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.
C. Humphrey & Associates, P.A. is an FDA Law Firm that represents domestic and international companies regarding a range of regulatory medical device law issues before federal and state agencies and courts involving the U.S. Food & Drug Administration (FDA), Federal Trade Commission (FTC) and U.S. Customs Border & Protection (CBP). Our FDA law firm provides regulatory counsel to clients in all phases of medical device product development and marketing. We have represented medical device firms, including manufacturers, distributors, and importers, in all facets of device regulation and compliance.
Our FDA Lawyers and FDA Consultants assist in array of FDA Legal Services for manufacturers and distributors of medical devices including:
- Clinical trials of medical devices under Investigational Device Exemption (IDE) regulations
- FDA classifications of medical devices and labeling issues
- Preparation of pre-market approval applications (PMAs), 510(k) Notifications and Humanitarian Device Exemptions (HDEs)
- Establishment registration and listing applications
- Combination products
- Medical Device Reports (MDRs), product recalls, market withdrawals, FDA site inspections and Quality System Regulation (QSR) requirements
- Development of pre-market approval and FDA clearance strategies
- Drafting and negotiating clinical trial, lab services, manufacturing and supply agreements
- FDA Import Alerts for Medical Devices
- Compliance issues relating to current Good Manufacturing Practices (cGMP), record keeping and product recalls
- FDA Inspections for Medical Devices
- Defending against FDA and FTC administrative and enforcement actions (e.g. FDA Warning Letters, FDA seizure, FDA injunction, FDA criminal and civil penalties)