Medical Device

Medical Device

The development, manufacturing, and marketing of a medical device require an in-depth understanding of the FDA regulatory process, as well as the ability to interact effectively with FDA personnel. Our firm offers comprehensive counseling and advocacy on FDA medical device matters, ranging from product clearance and approval to postmarket requirements and enforcement/compliance issues, product promotion, and advertising issues. We work with medical device regulation in the US, Canada (Health Canada), Mexico (COFEPRIS), Brazil (ANVISA), Europe (CE Mark), China, Japan, and the Middle East.

The US FDA regulates medical devices based on their intended use and risk level.  Medical devices are generally assigned to one of the three regulatory classes: Class I, Class II, and Class III.  The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance or approval to market.

Most, approximately 74%, of Class I devices do not require premarket clearance or approval from the FDA. Most of Class II and some Class I devices, on the other hand, require a 510(k) premarket notification for marketing. The submission of a 510(k) allows the FDA to determine whether the device is “substantially equivalent” to a device legally marketed in the U.S. (called a “predicate device”).  A 510(k) usually requires limited or no clinical trial.

For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA’s have not been called for. In that case, a 510(k) will be the route to market. A PMA requires full reports of safety and effectiveness of the device for its intended use, and therefore generally requires clinical trials.

Device Classification:  If you intend to market a new medical device (or an existing device for a new use), it is important to figure out early on the class(es) to which your device will be assigned so that you can start planning and preparing for the type of premarketing submission/application (if any) and regulatory requirements applicable for the device.

Sometimes a device may be assigned to multiple regulatory classes for different intended uses, and you may be able to sell the device immediately for a particular use without a 510(k). This approach can be beneficial especially for a start up company who can start generating income from a device for one intended use while preparing and applying for a 510(k) for another use.

Our firm provides clients with product development counseling, including determining possible classification(s) and regulatory requirements for your product, to help you develop a regulatory strategy that best aligns with your business goals.

Product Clearance: If a 510(k) application needs to be filed for your device, we can work with you or a FDA consultant to put together the necessary application materials and file the application with FDA.  Our firm can help you determine an appropriate predicate device(s) for your 510(k), and coordinate with investigators, research firms, contract manufacturers, and third parity reviewers, to conduct necessary safety and performance testing and analyses to support the 510(k) application materials. We have numerous strategic partners to help you find the right connections to complete your filing.

Labeling Review: FDA regulations require that certain information appear on medical device labels.  The information must also be formatted in accordance with the regulations.  Some devices, such as hearing aids, must also contain specified information in their instruction manuals to allow safe use of the devices.  We conduct labeling review for your medical devices to ensure conformance with FDA regulations.

Export Certificate: Struggling to determine whether you need a n Export Certificate to  Foreign Governments, Certificate of Exportability, or Certificate of a Pharmaceutical Product? Not sure whether to use Form 3613a or 3613b? We can help you apply for the right export certificate for your device. Our firm offers the experience to make the process simple and straightforward, eliminating confusion on what forms and attachments to include. Whether your already selling the product in the US or only looking to export we can help.

Advertising Review: Jurisdiction over medical device advertising is split between the FDA and the Federal Trade Commission (FTC). When the FDA enjoys jurisdiction, there are certain formal requirements that apply, and the device is misbranded if its advertising does not comply with any of the formalities. Even when the FDA does not have jurisdiction over a device’s advertising, however, the agency can use that advertising as a means of showing the intended use of the device to demonstrate. For example, if the manufacturer intends the device for an unapproved use.  This is why its important that your websites or promotional materials do not contain any statements that would imply any unapproved use of your devices.  Our firm conducts websites and advertising review for compliance with FDA/FTC regulations.

Off-Label “Promotion”: The Food and Drug Administration Modernization Act (FDAMA) describes certain conditions under which a medical device manufacturer could choose to disseminate medical and scientific information discussing unapproved uses of cleared or approved medical devices to healthcare professionals and certain entities.   FDAMA section 401 provides that, if these conditions were met, dissemination of such journal articles or reference publications would not be considered as evidence of the manufacturer’s intent that the product be used for an unapproved new use.

Further, understanding the need to attract and educate potential investors, the FDA does allow the display of investigational and unapproved devices at tradeshows, in direct mailing and on websites, only under certain conditions.

We  provide regulatory counseling to help you develop a policy and procedures for disseminating information about your investigational or unapproved device consistent with FDA regulations, and works with you to train your marketing staff on the procedures.

Facility Registration and Product Listing: FDA requires certain facilities that  manufacture, process, pack, store or distribute medical devices marketed in the U.S. file registrations with FDA, and list their medical devices with the agency.  Our firm assists companies with facility registration and product listing requirements.
Adverse Event Reporting and Record Keeping:  Since December 13, 1984, the FDA Medical Device Reporting (MDR) regulations have required companies who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify the FDA of the incident. The Safe Medical Devices Act (SMDA) of 1990 provided the FDA with two additional postmarketing activities, Postmarket Surveillance for the monitoring of products after their clearance to market and Device Tracking for maintaining traceability of certain devices to the user level.  We help clients develop process and standard operating procedures (SOPs) for identifying and reporting adverse events, train monitoring staff on the process, and conduct audits to assess compliance with MDR regulations.

Warning Letter & Border Detention Assistance:  If you received a warning letter from the FDA, or if your products were detained at the border, you may be able to ask the FDA to allow you to “fix” a deficiency so that you wouldn’t have to destroy the products or ship them out of the country. However, you only have a short period of time to make the request, and you need to act fast.  We can help you respond and take appropriate actions so you can get back to business.  Contact our firm as soon as possible for a free initial consultation.