Medical Devices
The medical device industry is fast-paced, quickly evolving, and highly regulated. Our lawyers 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, Our lawyer has extensive experience navigating medical device regulatory issues, regardless of whether CDRH or CBER is the FDA center in charge.
Our firm is versatile, representing a wide range of clients in the device industry, from the small, start-up venture to the large, veteran corporation.
Getting to Market and Obtaining FDA Approval
FDA organizes the products in the medical device industry into classes based on the risks level they represent, which are huge, encompassing products that range from tongue depressors and x-ray machines to implantable pacemakers. The device application process is also driven by the class of the device as determined by the FDA. Like a tongue depressor, a low-risk device has deemed a Class I device requiring no premarket approval and a tiny 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 before marketing and distribution, the submission process called a Premarket Approval (PMA) is used for this class.
Medium-risk devices deemed to be class II are approximately 43% and require Premarket Notification to FDA called 510(k). The submission requires a device manufacturer or distributor to demonstrate that it’s a new device is as good as the one already in the U.S market called a predicate device. And must also show that its device uses the same technology and the 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.
Our lawyers help 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. Therefore, 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 to draft and submit the submission packages appropriate to their devices and facilitate pre-submission meetings with the FDA, as necessary and assist our clients with follow-up and responses to FDA requests for additional information.
The firm is ready to help you with any of the following concerning your company’s submission to FDA :
- 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 and also list the medical devices they produce. The FDA has also promulgated extensive regulations regarding how medical devices must be manufactured. These regulations are called the Quality System (QS) regulation and are referred to as good manufacturing practices (GMPs). All of these manufacturing, registration, and listing requirements apply to foreign and domestic companies and individuals. Our 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
The firm goes the extra mile in an approach to assisting clients with medical device regulation and compliance seasoned in advising and guiding clients in labeling, advertising, and promoting medical devices. 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. Our compliance and the regulatory team have extensive experience in 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.
Dispute Resolution and FDA Enforcement
Agency disputes and agency actions occur in a highly regulated sector, like the medical device industry. Manufacturers, importers, and distributors must engage experienced counsel to assist when dispute resolution occurs, or reaction to FDA enforcement action needs to be addressed. On the wrong denial done to a manufacturer on 510(K) or PMA by the FDA, An experienced attorney can advise on options available. Likewise, a knowledgeable regulatory can advise a device distributor on an FDA Warning Letter received for a violation perceived by the agency, and enforcement action requires a written response within a specific time to avoid negative consequences. Our attorneys are well-versed in handling the following owing to their vast experience advising pharmaceutical companies in these types of enforcement actions:
- FDA establishment inspections and 483s
- Warning Letters and Untitled Letters
- Device recalls
- Injunctions
- Seizures
- Litigation
- Administrative appeals
- Agency hearings
Our advocates are familiar and comfortable working with the FDA to ensure our clients’ products, operations, and business interests are served and protected.
Medical Devices Import and Export
Stricter regulation has led due to terrorism concerns and the manufacture of products abroad that has created unique obstacles to the import and export of the products. Additionally, the number of government agencies involved in the enforcement of import and export regulations surrounding medical devices can make selling and buying these medical products internationally exceedingly complicated.
Our advocates have 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 due to their understanding of the necessity and intricacies of doing the business internationally, which helps clients succeed in the international market.