Medical Device Compliance — FDA

FDA’s Center for Devices and Radiological Health (CDRH) regulates medical device products and firms that manufacture, repackage, relabel, and/or import medical devices sold in the United States.  Under FDA’s rules and regulations, a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory” that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease intended to affect the structure or any function of the body of man or other animals.  In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.  The medical device attorneys at Gaitan Law Group are well-versed in the rules and regulations affecting the importation, sale and promotion of medical devices in the United States.

Medical devices are classified into Class I, II, and III, where regulatory controls increase progressively from Class I to Class III.  The device classification defines the regulatory requirements applicable to a specific device, where most Class I devices are exempt from premarket notification; most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval (PMA).

Classifying a medical device is a complicated initial step that is critical for determining the regulatory pathway for a device.  Through years of experience counseling medical device firms, the attorneys at Gaitan Law Group have developed a specialized proficiency in the regulation of medical devices.  Our attorneys work with medical device firms to classify products, chart the regulatory requirements applicable to the new medical device, and counsel clients on FDA premarket and postmarket requirements applicable to all medical devices distributed in the U.S., including:

• Medical Device labeling requirements
• Medical Device listing
• Medical Device facility registration
• Preparation and submission of medical device premarket notification 510(k)
• Quality System (QS) regulation,
• Medical Device Reporting (MDR)
• Advise on medical device safety compliance issues, including product recalls, Warning Letter responses, FDA inspections and Corrective Action Plans, and Import Alert petitions
• Counsel on FTC advertising and marketing requirements, as well as representation before the FTC and National Advertising Division of the Council of Better Business Bureaus (NAD)
• Respond to FDA Notice of Action, counsel on appropriate reconditioning options when submitting FDA Form 766 and negotiate releases of FDA detained goods
• Import and Export compliance

Whether you are seeking to market a new medical device, introduce into the U.S. a medical device that is currently marketed in a foreign jurisdiction, have received a Warning Letter from the FDA, or otherwise, our FDA compliance attorneys are ready to assist you.

If you are establishing a medical device manufacturing or repackaging facility in the State of Florida, our attorney can assist you with DBPR’s permitting requirements.

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