Medical advancements that improve our quality of life wouldn’t be possible without the innovative tools physicians use to deliver treatments and medications. Reliance on third-party vendors for these supplies can improve patient care, but it also introduces security risks. For instance, many hospitals and healthcare entities don’t know they’re doing business with a vendor that has violated the U.S. Food and Drug Administration (FDA).
The FDA debarment list for medical devices flags third parties guilty of non-compliance with FDA regulations. Checking this list regularly can protect your organization from connections with such businesses.
Understanding the FDA Debarment List
The FDA debarment list regarding medical devices contains the names of individuals and entities convicted of felonies or lesser charges related to developing, testing, marketing, and distributing medical devices. The FDA has sanctioned or debarred individuals on this list for various infractions, including:
- Falsifying data or information during product testing
- Fraud, waste, or abuse of federal funds (note that infractions can occur at any stage of product development)
- Taking or offering bribes in connection with medical device sales
- Marketing or distributing a product without FDA approval
- Failing to comply with consent decrees or court orders in response to a regulatory violation
- Repeated non-compliance with FDA regulations
People or entities on the FDA debarment list for medical devices fall under one of two classifications:
- Mandatory debarment: Permanent debarment from providing services because of a felony conviction
- Permissive debarment: Debarment lasting up to several years due to a federal misdemeanor conviction, state felony conviction, or act of conspiracy or aiding to commit a felony or misdemeanor
Do You Work with a Vendor on the FDA Debarment List?
Establishing a business relationship with a third-party vendor offers medical and financial opportunities for your organization. However, unknowingly dealing with a vendor on the FDA debarment list for medical devices can put your entity at risk for fines, legal penalties, financial losses, and a tarnished reputation.
Screening potential and current vendors against the FDA debarment list should be part of your routine background checks. In addition to screening prospective business partners, you should regularly check the vendors you’re currently working with. Avoiding FDA-sanctioned vendors and suppliers protects your organization from non-compliance incidents and preserves your credibility with patients, stakeholders, and community members.
You can search the FDA medical device debarment list for the name of the person or entity sanctioned, the effective date, and the term of debarment, which could be permanent or for a finite period (e.g., 25 years). You can also access more detailed information, such as the reason(s) for debarment.
Make Sure Your Vendors Are Safe with Compliancy Group Software
Detecting which suppliers or vendors to avoid can be challenging and time-consuming without technical support. To this end, Compliancy Group offers software and other resources to help you screen your vendors and ensure that your external partners are above board. With our software, it’s easy to check prospective suppliers against the FDA debarment list for medical devices and pharmaceuticals.
At Compliancy Group, we understand the importance of avoiding the devastating consequences of working with non-compliant vendors and suppliers. Contact us today to learn how our software and other services can streamline your vendor monitoring activities.
