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Medical Device Compliance

Register a Medical Device with the FDA

Ms. Capote helps clients with matters related to registering with the FDA and also with matters related to FDA compliance.

The United States Food and Drug Administration (FDA) monitors medical device corporations who must comply with the Center for Devices and Radiological Health (CDRH) while selling medical device products in the United States. The FDA regulates medical device products and firms that manufacture, repackage, relabel, or import medical devices sold in the United States.

Under the FDA 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, treatment, or prevention of disease intended to affect the structure or any function of the body. In addition, CDRH regulates electronic radiation products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, and CT scan machines.

How to register medical device with FDACapote Law Firm medical device attorneys have experience advising clients on the rules and regulations affecting the importation, sale and promotion of medical devices in the United States. The FDA classifies medical devices into Class I, II, and III with regulatory controls increasing from Class I to Class III. The FDA medical device classification defines the requirements for each specific device as follows:

  • Class I devices are exempt from premarket notification
  • Class II devices require Premarket Notification 510(k)
  • Class III devices require Premarket Approval (PMA)

Our medical device lawyers can assist you with classifying a potentially marketable medical device using the FDA guidelines. Understanding the FDA rules and regulations regarding the three different classes can be complex, yet necessary, in determining the future for a device.

Capote Law Firm FDA compliance attorneys advise and represent drug companies on the requirements of marketing OTC drugs in the United States. Our dedicated FDA lawyers work with drug manufacturers, distributors, importers and exporters in the U.S. and internationally with FDA requirements, including:

  • FDA rules on medical device labeling;
  • FDA medical device facility registration;
  • FDA medical device advertising and marketing regulations;
  • Medical device product recalls;
  • FDA inspections and Corrective Action Plans;
  • Represent FDA medical device companies against the FTC and National Advertising Division of the Council of Better Business Bureaus (NAD);
  • Import and Export compliance;
  • Preparation and submission of medical device premarket notification 510(k);
  • Quality System (QS) regulation;
  • Medical Device Reporting (MDR).

Whether you are seeking to market a new medical device, introduce an existing medical device into the U.S. market that is currently marketed in a foreign jurisdiction, have received a Warning Letter from the FDA, or any other FDA compliance issue, contact Capote Law Firm for a consultation and to discuss the future of your medical device within the U.S. market.

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