The medical device industry is fast-paced, quickly evolving, and highly regulated. Fuerst Ittleman David & Joseph attorneys have vast experience handling the intricacies of medical device regulation. FDA’s Center for Device and Radiological Health (CDRH) is the primary center within the FDA responsible for medical device regulation and oversight. FDA’s Center for Biologics Evaluation and Research (CBER) also shares jurisdiction with CDRH regulating devices related to cellular and blood products. Fortunately, Fuerst Ittleman David & Joseph has extensive experience navigating medical device regulatory issues, regardless of whether CDRH or CBER is the FDA center in charge.
Our firm represents medical device firms, including manufacturers, distributors, and importers, in all facets of device regulation and compliance. Fuerst Ittleman David & Joseph is a versatile firm representing a wide range of clients in the device industry, from the small, start-up venture to the large, veteran corporation.
Obtaining FDA Approval and Getting to Market
The medical device industry is huge, encompassing products that range from tongue depressors and x-ray machines to implantable pacemakers. The FDA organizes these products into different classes based on the risk level they present. The device application process is also driven by the class of the device as determined by the FDA. A low-risk device, like a tongue depressor, is deemed a Class I device requiring no pre-market approval and very little barrier to the marketplace. On the other end of the spectrum, a high-risk device, like an implantable pacemaker, is categorized as a Class III device requiring extensive testing, validation and research prior to marketing and distribution. The FDA requires a submission process called a Premarket Approval (PMA) for Class III devices.
Approximately 43 percent of all medical devices are medium-risk devices, which are deemed Class II and require a Premarket Notification to FDA called a 510(k). This submission requires the device manufacturer or distributor to demonstrate that its new device is just as safe and effective as a device that is already in the U.S. market, called a predicate device. To demonstrate safety and effectiveness, the manufacturer or distributor must show that its device uses the same technology and same intended use as the predicate device. Once a manufacturer or distributor has demonstrated this “substantial equivalence,” the FDA will clear the device’s 510(k) and it can be legally imported, marketed, or sold in the United States. Examples of these devices include, among others, powered wheelchairs, acupuncture needles, some powered muscle stimulators, and some centrifuge devices.
Fuerst Ittleman David & Joseph helps clients understand where their products fall in the FDA’s classification scale and what steps need to be taken to pursue the appropriate regulatory pathway. We assist our clients in compiling 510(k) and PMA submissions, including identifying predicate devices and facilitating relationships with outside consultants as necessary for testing and validation. Our attorneys work with our clients in drafting and submitting the submission packages appropriate to their devices. We facilitate pre-submission meetings with the FDA, as necessary, and assist our clients with follow-up and responses to FDA requests for additional information.
Our firm can help you with your company’s submission to FDA. We are ready to help you with any of the following:
• Premarket Approval Applications (PMAs)
• Premarket Notifications (510(k)s)
• De novo petitions
• Investigational Device Exemption (IDE) Applications
• Combination products Request for Designation (RFD)
Medical Device Manufacturing
Manufacturers and importers of medical devices marketed and sold in the United States must register their establishments with the FDA. Additionally, manufacturers must list with the FDA the medical devices they produce. The FDA has also promulgated extensive regulations regarding how medical devices must be manufactured. These regulations are called Quality System (QS) regulation, and are sometimes referred to as good manufacturing practices (GMPs). All of these manufacturing, registration, and listing requirements apply to foreign and domestic companies and individuals. Fuerst Ittleman David & Joseph’s attorneys are knowledgeable and familiar with these requirements and can help your company comply with the FDA’s manufacturing and registration regulations.
Labeling and Marketing
Fuerst Ittleman David & Joseph’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. Our compliance and regulatory team 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 conform with FDA and FTC regulations.
FDA Enforcement and Dispute Resolution
In a highly regulated sector like the medical device industry, agency disputes and agency actions occur. When dispute resolution or reaction to FDA enforcement action needs to be addressed, it is critical that manufacturers, importers, and distributors engage experienced counsel to assist. For example, a medical device manufacturer may believe that its 510(k) or PMA was wrongly denied by the FDA. An experienced attorney can advise on the options available after such a denial. Likewise, a knowledgeable regulatory can advise a device distributor on a FDA Warning Letter received for a violation perceived by the agency. That type of enforcement action requires a written response within a specific time period to avoid negative consequences. Our attorneys have extensive experience advising medical device companies in these types of enforcement actions and resolutions of agency disputes. We are well-versed in handling:
• FDA establishment inspections and 483s
• Warning Letters and Untitled Letters
• Device recalls
• Administrative appeals
• Agency hearings
Fuerst Ittleman David & Joseph is familiar and comfortable working with the FDA to ensure our clients’ products, operations, and business interests are served and protected.
Importing and Exporting Medical Devices
The global economy has created unique obstacles to the import and export of medical devices. Terrorism concerns and the manufacture of products abroad have led 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 medical products internationally exceedingly complicated.
Fuerst Ittleman David & Joseph has experience working and communicating with Customs and Border Patrol (CBP) and the 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 the international market.