The U.S. Food and Drug Administration (FDA) regulates medical devices under authority granted to the agency by the Federal Food, Drug and Cosmetic Act (FDCA). The FDA’s Center for Device and Radiological Health (CDRH) is responsible for day-to-day regulation.
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), which is: (1) intended to affect the structure or function of the body, which does not achieve its primary purpose through chemical action or metabolizing or (2) intended for use in diagnosis of a disease, or in the cure, mitigation, treatment or prevention of disease in humans or animals.
All medical devices are assigned to one of three regulatory classes based on the level of controls needed to assure safety and efficacy. These classes also determine the type of clearance or approval needed from the FDA in order to bring a product to market.
- Class I medical devices require only general controls and have the lowest level of risk (ex. foam rollers, gauze)
- Class II medical devices require general and specific controls and carry greater risk (ex. at-home testing products, wheelchairs)
- Class III medical devices have general control and require premarket approval since failure of the device would likely cause serious harm or injury to the user (ex. pacemaker, heart valve)
We assist manufacturers and distributors with determining the correct classification and appropriate regulatory path with the FDA – whether that be through a predicate search or request for formal opinion in the form of a 513(g) from the agency. We also assist with:
- Premarket Approval (PMA), de novo, or 510(k) Notification submissions
- Label and labeling reviews, advertisements, Internet marketing and social media networks for your medical device
- Changes and modifications to previously cleared medical devices
- Communications between the FDA, testing facilities, and consultants during the submission process
- Registration, listing and U.S. agent representation
- Communications with the FDA and response to inquiries during the submission process
- Good Manufacturing Practices as set forth in Quality Systems Regulations
- Audits of your operations and risk assessment related to non-compliance
- Medical device Standard Operating Procedures (SOPs)
- Defense against FDA and FTC enforcement actions such as product recalls, FDA detentions and refusals, warning letters, 483s, adulteration and misbranding charges, import alerts, or claims brought by state and federal prosecutors for violation of safety regulations, and for false labeling and advertising
- U.S. Customs matters such as Form 28s, liquidated damages, criminal investigations, seizures, HTS classifications, free trade agreements, country of origin issues, and import/export guidance
- Analysis and advocacy with respect to relevant legislation regulatory matters
- Obtaining patents and trademarks, and gray market protection strategies
For more information, please contact Ryan Fournier.