When FDA Trust Is Broken: Lessons from the MedLink Scandal

Ariana Wilson and Mark Drlik seated against a white background, wearing lavalier microphones. The woman on the left has long brown curly hair and is wearing a beige cardigan over a taupe top. The man on the right is wearing glasses and a blue button-up shirt. They appear to be engaged in conversation or a video interview.
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When FDA Trust Is Broken: Lessons from the MedLink Scandal

Sector: Diagnostics

A recent FDA announcement has sent shockwaves through the MedTech community: MedLink, a third-party test house, was found falsifying test data. The consequences? All pending FDA submissions that relied on MedLink’s data have been rejected, delaying or derailing device approvals and costing companies precious time and trust.

In this episode of MedDevice by Design, Ariana Wilson and Mark Drlik examine what happened, what it means for medical device innovators, and how the FDA’s ASCA (Accreditation Scheme for Conformity Assessment) program helps reduce regulatory risk.

The FDA discovered that MedLink had falsified testing data, compromising the integrity of submissions relying on that information. As a result, those submissions are now invalid, and the affected companies must retest their devices and resubmit, costing them months of delay and significant financial loss.

Why ASCA Accreditation Matters

To prevent this kind of disruption, the FDA established the ASCA program in 2020. Labs that receive ASCA accreditation are thoroughly vetted, giving the FDA and submitting companies greater confidence in their test results. Submissions that include ASCA-accredited data benefit from reduced review times—sometimes shaving weeks or even months off approval timelines.

The Tradeoff: Fewer Labs, Higher Costs

As of late 2024, only 47 test houses hold ASCA accreditation, limiting access for some companies. Additionally, ASCA-accredited testing can be 10% to 30% more expensive than non-accredited alternatives. Still, that investment offers peace of mind and regulatory security—especially when the risk of working with an unreliable lab is so high.

Key Takeaway: Prioritize Risk Management


This episode is a reminder of the critical role third-party labs play in the regulatory process. Choosing an ASCA-accredited lab is not just about speed; it’s about reducing risk, protecting your investment, and ensuring trust in your data.

X-ray image showing two human knees side-by-side. The right knee appears intact with natural bone structure, while the left knee has a visible knee replacement implant, including metallic components. A bold caption in the upper center reads "Bone or not?" and a red curved arrow points from the text to the knee with the implant, emphasizing the contrast between natural bone and artificial joint.

In this episode of MedDevice by Design, Ariana and Mark dive into the biomechanics and materials science behind osseointegration for implants.

Split image showing two close-up views of a human eye. On the left, the eye is seen through thick black-framed glasses, indicating impaired vision. On the right, the same eye is enhanced with a futuristic digital overlay of concentric circles and interface elements, suggesting advanced vision restoration technology. A red curved arrow points from left to right, implying improvement. Bold text at the top reads "Restoring Vision?"

Ariana and Mark explore how accommodative intraocular lens technology may one day restore natural vision for people who require cataract surgery or suffer from presbyopia. As Mark shares, traditional bifocals are not ideal, and new lens solutions may offer better outcomes.

Brain-computer interface - A man wearing a brain-computer interface (BCI) headset sits in a clinical setting, concentrating as he appears to control a robotic arm with his mind. His head is overlaid with digital graphics representing brain activity. A doctor in a white lab coat stands nearby, monitoring the interaction. Onscreen data displays in the background suggest medical or neurological analysis. Bold text on the image reads "Brain-Controlled Tech?"

We explore the world of brain-computer interfaces (BCIs) and the challenges of capturing thought into action. Mark Drlik and Ariana Wilson walk through how these systems translate brain activity into control signals for devices—without needing surgical implants.

X-ray image of a human chest showing bones in high contrast. A visible electronic device, likely a pacemaker or implant, is located in the upper left chest area. A bold red arrow points to the device with a label in black and white text reading “definitely not bone.”

Mark and Ariana explore the surprising versatility of barium sulfate—a material used widely in both diagnostic procedures and medical device manufacturing. While many recognize it as the contrast agent you drink before an X-ray, it’s also a key additive that enhances plastic components across the healthcare industry.