Fuerst Ittleman is a firm well-versed and vastly experienced in the intricacies of medical device regulation. The Center for Device and Radiological Health (CDRH) is the center within the FDA responsible for medical device regulation and oversight. As a firm familiar with the ever-changing law concerning medical devices, Fuerst Ittleman has experience navigating through CDRH-regulated issues.
We have represented medical device firms, including manufacturers, distributors, and importers, in all facets of device regulation and compliance. Fuerst Ittleman is a versatile firm representing a wide range of clients, from the small, start-up venture to the large, veteran corporation.
Premarket Clearance, Investigation of Medical Devices, & Good Manufacturing Practices
The Fuerst Ittleman food and drug associates have considerable knowledge and experience assisting clients in determining whether a product is deemed a medical device under the control of CDRH, if it falls under some other form of FDA regulation, or is removed from FDA authority entirely. Our team is experienced in the classification of medical devices as well as the special regulations governing radiation-emitting devices.
Fuerst Ittleman has expertise in drafting and filing Premarket Approval Applications (PMAs), Premarket Notifications (510(k)s), and Investigational Device Exemption (IDE) Applications. Additionally, our team is knowledgeable in FDA regulations governing Good Manufacturing Practices (GMPs), Quality System Regulations (QSR), and Medical Device Reporting (MDR).
FDA Enforcement and FDA Dispute Resolution
We have extensive experience assisting medical device companies and importers with FDA establishment inspections, FDA 483 notifications and warning letters, as well as device recalls, injunctions, and seizures. Fuerst Ittleman is familiar and comfortable with working with FDA to ensure our clients’ products, operations, and business interests are served.
Medical Device Marketing, Advertising, and Labeling
Fuerst Ittleman’s approach to assisting clients with medical device regulation and compliance goes the extra mile. We are seasoned in advising and guiding clients in all aspects of labeling, advertising, and promotion of medical devices. The compliance and regulatory team at Fuerst Ittleman has extensive experience reviewing product labeling, including packaging, product inserts, and instructional manuals as well as assessing advertising and promotional materials like website pages and video and print advertisements to ensure total legal compliance. We are well-versed in analyzing and evaluating medical device claims to make sure that all claims and statements are in conformity with FDA and FTC regulations.
Litigation
The litigation team at Fuerst Ittleman handles all aspects of litigation surrounding medical devices and is well-equipped to deal with enforcement issues involving FDA, the Department of Justice (DOJ), and the Office of Inspector General (OIG) of the Department of Health and Human Services).
Import and Export
The global economy has created unique obstacles to the import and export of medical devices. Terrorism concerns and the manufacture of products abroad have lead to stricter regulation. Additionally, the number of government agencies involved in the enforcement of import and export regulations surrounding medical devices can make the process of selling and buying these devices internationally exceedingly complicated.
Fuerst Ittleman has experience working and communicating with Customs and Border Patrol (CBP) and FDA’s Division of Import Operations and Policy (DIOP) to assist clients in the efficient import and export of medical devices. We understand the necessity and intricacies of doing business internationally and are very capable of helping our clients succeed in this global market.
