Medical Devices and Combination Products

Medical devices are part of our everyday lives and include simple products such as surgical gloves to complex equipment such as magnetic resonance imaging (MRI) units and implantable pacemakers. The Medical Device industry is regulated in the US by the FDA’s Center for Devices and Radiological Health (CDRH). The FDA requires medical device manufacturers to implement a Quality Management System in accordance 21 CFR Part 820 – Quality System Regulation (QSR). Manufacturers, specification developers, contract manufacturers, re-labelers/re-processors, and even some distributors must implement a quality management system compliant with the QSR. Medical device manufacturers must also conduct internal audits of their quality management system in accordance with the QSR. Failure to conduct internal audits can result in product quality issues, lack of process improvements, or regulatory compliance issues. 

There are three classes of medical devices: Class I, II, and III with Class III being the most complex. Most low-risk/Class I medical devices are marketed without prior FDA review, meaning they are exempt from Premarket Notification 510(k). Most medium-risk /Class II medical devices must show that they are “substantially equivalent” to an existing device and require Premarket Notification 510(k); and most Class III devices require Premarket Approval.

Medical devices can also be combined with drug products and/or biological products to create Combination Products. The products can be regulated by various divisions of the FDA [Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH)] depending on what components are in the product.  Combination products must comply with the regulations outlined in 21 CFR Part 4. The various regulatory pathways can create unique challenges for companies wishing to bring a combination product to market.  Examples of combination products are metered dose inhalers, pre-filled syringes, auto-injector pens, transdermal patches, and nasal sprays. 

Jeiven’s team of medical device experts has provided consulting, auditing and training services to companies of all sizes from small/virtual start-ups to large multinational organizations. We can help navigate the complex regulatory pathways required for medical devices and combination products and can provide guidance related to the Quality requirements both in-house at your company and at your contractors. The FDA’s expectations for maintaining control of your processes and those of your contractors are the same regardless of the size of your organization. We can help you meet those expectations in a way that makes sense for your company.  We have auditors around the world who can audit your contractors and help qualify them. They can also work to remediate issues, if any are found so that your projects can move forward in a timely fashion. 

Our medical device experts can also assist with clinical trials for medical devices and combination products including all GCP-related activities and clinical supplies project management.