Medical Devices

The U.S. Food and Drug Administration (FDA) regulates medical devices to ensure their safety and efficacy for users. This regulatory oversight encompasses a wide array of products, ranging from simple tools like tongue depressors to advanced technologies such as robotic surgical equipment and life-sustaining heart valves.

The FDA classifies devices into three categories based on the risk they pose to patients, with Class I devices being the least risky and Class III devices being the most. Manufacturers must adhere to specific regulatory pathways for approval before their devices can be marketed, including premarket notification (510(k)), premarket approval (PMA), and de novo classification, depending on the device’s classification and intended use.

At Asebey Life Science Law, we specialize in helping clients navigate the intricate FDA regulatory framework for medical devices. Our services include advising on the most appropriate regulatory pathway for device approval, assisting with the preparation and submission of regulatory filings, and ensuring compliance with FDA’s quality system regulations (QSR). We also offer strategic counsel on post-market surveillance and reporting obligations to ensure ongoing compliance.

Additionally, we support our medical device and in vitro diagnostic (IVD) company clients by providing transactional support, including manufacturing, licensing, and distribution agreements, as well as preparation for capital raises and M&A events. Our goal is to help our clients bring their innovative medical devices to market efficiently while upholding the highest standards of safety and effectiveness.

Services Provided

510(k) and PMA submissions to FDA
FDA classification of medical devices
Label, website, and advertising reviews for FDA compliance
Regulatory opinions regarding appropriate FDA regulatory pathway for approval / clearance of medical devices
Class I device listing with FDA
FDA Warning Letters and 483 responses to FDA
FDA and state facility inspection management
IVD regulatory compliance
Removal from FDA Import Alert
Recall and crisis management services
CBP import compliance

Representative Matters

Led regulatory due diligence and advised Cardinal Health, Inc. on FDA regulatory requirements in connection with a $240M acquisition of a clinical decision support (CDS) software company
Provided crisis management services, supervised implementation of corrective and preventive action (CAPA) plan, and interfaced with FDA in a self-disclosure of quality system deficiencies of a U.S. company’s Class III medical device
Provided guidance to a U.S. medical device company on advertising compliance matters and potential unfair competition claims against a competitor with regard to a product utilizing 3-D printing for custom fabrication of medical orthotics
Advised an Italian manufacturer of medical devices on removal from FDA Import Alert and response to FDA Warning Letter
Provided FDA regulatory guidance to various Health IT and medical mobile app companies regarding product registration and clearance, as well as FTC advertising compliance
Advised a Japanese Global 500 company on the clearance of a Class II IVD device in the U.S.
Provided counsel to a global medical device company on the U.S. portion of a global Class II recall, creation and implementation of a CAPA, and mitigation of possible consumer and class action litigation
Provided counsel to a U.S. medical device company on response to FDA Warning Letter and assisted in the creation of a CAPA related to GMP quality issues
Initiated Lanham Act unfair competition litigation on behalf of a medical device client against a series of U.S. distributors and a foreign manufacturer of a non-cleared Class II medical device

Tell us more about your regulatory needs so we can help you succeed.

Request a consultation