Drug Quote by Judith A. Johnson
““FDA classifies devices according to the risk they pose to consumers. Premarket review is required for moderate- and high-risk devices. There are two paths that manufacturers can use to bring such devices to market. One path consists of conducting clinical studies, submitting a premarket approval (PMA) application and requires evidence providing reasonable assurance that the device is safe and effective. The other path involves submitting a 510(k) notification demonstrating that the device is substantially equivalent to a device already on the market (a predicate device) that does not require a PMA. The 510(k) process results in FDA clearance and tends to be much less expensive and less time-consuming than seeking FDA approval via PMA.””
About This Quote
Source Regulation: FDA guidance documents, United States, 2020
The FDA separates medical devices by risk, requiring more rigorous premarket approval for higher‑risk items and allowing a faster, cheaper 510(k) route for devices similar to existing ones.
In simple terms: High‑risk devices need strict review; low‑risk can use a simpler clearance.
Key Takeaway
Choose the regulatory path that matches your device’s risk profile.
Themes
regulation
medical devices
risk assessment
approval processes
Mood
cautious
analytical
Type
informative
technical
When to use this quote
- product development
- clinical testing
- market entry strategy
- budget planning
Key Concepts
FDA
premarket approval
510(k)
risk classification
Questions to Reflect On
- How do you assess whether a predicate device is truly safe?
- When might a higher‑risk pathway be worth the extra cost?
A Different Perspective
The 510(k) route may not guarantee long‑term safety if the predicate device had hidden issues.
![“When a drug comes out [that's broadly prescribed] there are going to start to be a lot of people on it [in a million person cohort] and you might get therefore an early signal of something unexpected that hadn't come through in the clinical trials. And I'm sure [drug companies] would love it if…” quote by Francis Collins](https://sms4smile.com/quotes/img-quotes/dda/francis-collins-5281_able_when-a-drug-comes-out-that-s-broadly-pre_408526.jpg)
