A PMA is more in-depth than a 510k – it is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants along with laboratory testing.

The established case law allows for a De Novo (meaning ‘new’) hearing as if the original hearing had not occurred, and more importantly, allows an individual to include testimony from outside parties and witnesses. If the court denies a party’s ability to a full hearing it could lead to a reversal on appeal.

The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). The submitter may market the device immediately after 510(k) clearance is granted.

The average length of time for clearance under the traditional 510(k) pathway is 177 days, or nearly six months. Just 19% of devices on the 510(k) pathway are cleared within three months. The average number of days it takes to clear a device via 510(k) varies according to the device category.

How Much Does a FDA 510k Approval Cost? The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process.

Although FDA’s 510(k) program is the most commonly used device review pathway for medical devices in the US, not all devices need a formal submission to be legally marketed. Some medical devices are exempt from 510(k) clearance, meaning that manufacturers can market their device without clearance from the FDA.

Summary

Human Clinical Trial Phases

• Phase I studies assess the safety of a drug or device.
• Phase II studies test the efficacy of a drug or device.
• Phase III studies involve randomized and blind testing in several hundred to several thousand patients.

The purpose of phase III is to evaluate how the new medication works in comparison to existing medications for the same condition. To move forward with the trial, investigators need to demonstrate that the medication is at least as safe and effective as existing treatment options.

Phase 3 is the final phase before a treatment receives FDA approval. Following FDA approval, a treatment goes through Phase 4. This phase involves the largest group of participants. It can last for several years as researchers continue to monitor the efficacy and safety of the treatment.

Researchers design Phase 3 studies to demonstrate whether or not a product offers a treatment benefit to a specific population. Sometimes known as pivotal studies, these studies involve 300 to 3,000 participants.

1 to 4 years

The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use. A Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.

Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III.

The primary source of trial failure has been and remains an inability to demonstrate efficacy. Hwang et al. [58] assessed 640 phase 3 trials with novel therapeutics and found that 54% failed in clinical development, with 57% of those failing due to inadequate efficacy. Clinical trials also fail with respect to safety.

Peeling the onion: What are the drivers behind these Phase III failures? An examination of recent failures in Phase III studies and innovative approaches to reduce risk. (39% failure rate), whereas 67% of all drug trials moved to the application phase (33% failure rate).

The estimated median cost for a pivotal clinical trial came out to $48 million, with an IQR of $20 million to $102 million. In the 2014 Tufts study, researchers estimated the average cost of a Phase III trial to be $255 million.