The Medical Device Amendments of 1976 to the Food Drug and Cosmetic Act led to the classification of approximately 1,700 different generic types of devices with 19 medical specialties and three regulatory classes of devices based on risk.
Whether your product is a class I, II or III device, EAS Consulting Group, LLC. has the expertise to provide wide-reaching guidance as well as act as a conduit between manufacturers and marketers of devices and FDA.
No matter the type of device, whether your company is in need of a 510(k), a Premarket Approval, IDE, QSR audit, US Agent or registration assistance or the filing of petitions, exemptions and responding to warning letters and 483s, EAS can help.
EAS Consulting Group, LLC (EAS) can make recommendations and provide assistance with FDA submissions for your product(s). With scientific experts in toxicology, radiology, chemistry and biology and authorities in FDA laws and regulations, EAS’ consultants can lead your company through the process of obtaining necessary background data, filing the submissions, and following-up as needed during the submission process.
- Premarket Notifications or 510(k) Submissions: Premarket Notification (510(k)) submissions for medical devices are required by FDA to ensure that products are safe for use. They are reviewed by, the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostics and Radiological Health (OIR) which fall under the CDRH.
- De Novo Applications: De Novo applications offer an expedited pathway to approval for class I and class II products for which there is no currently approved predicate.
- Investigational Device Exemptions (IDE): An IDE allows an investigational device to be used in a clinical study to determine its safety and effectiveness, often in support of a PMA. Once an IDE is approved, the device can be shipped for use in the trials without the other requirements for medical devices as specified in the FD&C.
- Premarket Approvals (PMA): A Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, that support or sustain life. It is the most stringent of device marketing requirements by FDA.
Recalls are a unique challenge for the industry since products are either one step away from the consumer or the consumer has already purchased the recalled product. Both FDA and the states conduct recall effectiveness checks. EAS can evaluate your recall plans and assist in developing, executing and evaluating a simple to complex mock recall.
Under 21 CFR Part 820 the Quality System Requirements, or Good Manufacturing Practices (GMPs), includes requirements related to the methods used in and the facilities and controls used for designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements. Because the regulation must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device. Rather, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device. EAS consultants provide a detailed understanding of the specific QSR – GMP requirements for your specific medical device, ensuring compliance with the most applicable regulations.
Those who produce and distribute medical devices intended for use in the U.S. must register annually with the FDA. Most who are required to register with the FDA is also required to list the devices that are made at their facilities and the activities that are performed on those devices. If a device requires PMA or notification before being marketed in the U.S., then the FDA premarket submission number (510(k) and/or, PMA) should also be supplied.
EAS Consulting Group provides US Agent services to international clients in various FDA regulated areas to register the facility or products as needed and acts as a conduit of information between FDA and the foreign firm. By quickly responding to questions and concerns in a timely manner EAS helps clients get their compliant products to the U.S. marketplace as quickly as possible.
FDA must be permitted to inspect the facility at any time in accordance with the FD&C Act to determine compliance with FDA regulations for safety and to identify any potential problems before the products enter the U.S. marketplace.
EAS Consulting Group is available to provide a mock FDA inspection of foreign facilities to determine deficiencies and/or to develop a corrective action plan either before FDA makes its initial inspection or if FDA finds deficiencies that need correction.
In the event that FDA issues a 483 or warning letter or the Department of Justice files a consent decree, EAS can assist with a timely and appropriate response. EAS also assists as a third-party expert for review, audit, and evaluation of facilities and documentation, and can formulate a remediation plan and response in compliance with FDA requirements.
EAS offers import entry assistance for foreign firms whose products are in detention. Our consultants work with FDA and Customs Border Patrol to determine the reason for detention and assist clients in developing and executing a remedy allowing for the expedited release of affected products. Working as a foreign company’s US Agent, EAS offers the best in regulatory solutions for your most pressing import needs.
EAS’ labeling staff is highly experienced in the specialized requirements for medical device labels. With our detailed knowledge of FDA labeling requirements, we can review your label for formatting and claims and advise you on how to be in compliance.
EAS is staffed with former FDA investigators and industry auditors that are available to audit firms that are being considered for acquisition or investment or which are being considered as a potential contract manufacturer, packager, distributor or testing laboratory. EAS can perform due diligence audits that will assess their current level of compliance with FDA GMPs and other regulations and identify potential quality and regulatory risks and gaps. By having EAS on the due diligence team regulatory and compliance risk can be minimized.
EAS is frequently requested to bring our popular public training programs in-house, offering a dedicated training for employees and customizing the content as-needed to focus on specific areas of need. Or join us at one of our upcoming training programs coming to a city near you.
In the industries regulated by FDA, such as those in the pharmaceutical, medical device, food, dietary supplement, and cosmetic business, compliance issues are of great importance. When disputes arise, the regulatory compliance status of a product or facility is often a key issue and can make a significant difference in how the matter will be resolved. In such cases, it is critical to have the assistance and advice of experts who are both experienced and knowledgeable in FDA regulations and industry practices, and who will be perceived as independent and objective. Whether a dispute is resolved via mediation or litigation it is imperative to have a well-respected and knowledgeable expert witness acting on your company’s behalf. EAS independent advisors and consultants are routinely called to serve as expert witness in a variety of cases and provide the in-depth, detailed attention required in these cases.
EAS offers one of the most experienced groups of consultants available on FDA regulatory compliance issues. We offer a team of former high-level FDA officials and industry professionals who will share their expertise with our clients. Our consultants have an average of over 25 years of regulatory experience and include some of the most well-known and highly respected names in the industry. As new standards and regulations proliferate, EAS keeps abreast of the changing regulatory landscape, allowing us to deliver up-to-the-minute policy advice to our clients. Our experts have the knowledge, qualifications, and experience necessary to explain and clarify the issues to our clients and the courts while establishing credibility and persuasiveness as witnesses.
EAS offers assistance in adjudicating insurance claims and servicing as an expert in depositions and civil litigation cases. With high-level experts in all areas of FDA regulations, EAS is well recognized as representing the industry in all manner of court cases.