What does FDA substantially equivalent mean?
What does FDA substantially equivalent mean?
Substantial equivalence means that the new device is as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate it: has the same intended use as the predicate; and. has the same technological characteristics as the predicate; or.
Can you sell medical devices without FDA approval?
In the U.S., FDA regulates the sale of medical device products. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA.
Does 510 K need clinical trials?
The vast majority of medical devices on the U.S. market were given the government’s green light in a process known as the 510(k), which requires no clinical trials and very little oversight.
What is a 510k medical device?
A 510(k) is the technical dossier required by the US Food and Drug Administration (FDA) to sell a medium-risk medical device or IVD in the United States. It is formally called a Pre-market Notification. A 510(k) contains detailed technical, safety, and performance information about a medical device.
How do you prove substantial equivalence?
How to Demonstrate Substantial Equivalence in 5 Easy Steps
- Substantial equivalence overview.
- Determine if your product’s intended use is substantially equivalent to a predicate device.
- Identify similarities and differences between your product and predicate device to be included in comparison table.
What is substantial equivalency?
Substantial equivalency is a determination by a board of accountancy or its designee that the education, examination and experience requirements contained in another jurisdiction’s statutes and administrative rules are comparable to or exceed the requirements specified in the act or that an individual CPA’s education.
What is the difference between a Class 1 and Class 2 medical device?
FDA Medical Device Classifications Class I: A medical device with low to moderate risk that requires general controls. Class II: A medical device with a moderate to high risk that requires special controls. Class III: A medical device with high risk that requires premarket approval.
What is the difference between 510k and FDA approval?
The 510(k) clearance process doesn’t require companies to provide safety or effectiveness data from clinical trials. But the FDA still evaluates the device’s safety and effectiveness by comparing it to other devices. The FDA requires that companies submit a 510(k) at least 90 days before marketing the device.
How long does it take to get 510k approval?
Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.
