Tag Archives: FDA Approval

Does AI need FDA approval for Medical devices?

What is Artificial Intelligence (AI)

According to Merriam-Webster, artificial intelligence is defined as the capability of a machine to imitate intelligent human behavior. But what does that really mean? Artificial intelligence is actually a pretty old term. In fact, you can trace its roots back over six decades to when mathematician John McCarthy coined it in 1955. Even then, it was clear that AI technology had massive potential to augment our lives and make all kinds of processes easier.

Over time, as AI continued to evolve and technology advanced, experts began to envision how AI could be used in conjunction with other technologies to increase their efficacy. This kind of combination approach has a wide range of applications across multiple industries, including healthcare.

Benefits of AI

We tend to think of AI as robots and computers talking in a human-like way or beating humans at strategic games. But actually, AI is also used in countless medical applications that have already saved lives and improved the lives of many patients around the world.

The real value of artificial intelligence is its ability to help humans make faster and better decisions. Think about your smartphone. Its predictive text function doesn’t actually write your text messages. It simply predicts what word you’re trying to type next so that you can quickly and easily send a message without having to type out each word letter by letter.

AI in Medical Devices

As research into artificial intelligence has increased, so too has it been adapted for medical purposes. Now, many hospitals are using artificial intelligence to assist with certain diagnostic procedures and checkups. Artificial intelligence is being used in both simple and complex ways: from diagnosing eye disease to reading radiographs—there’s even an artificial intelligence diagnosis tool that can predict cancers.

This has led to many wondering whether or not artificial intelligence requires FDA approval. The short answer is yes. All medical devices need to be approved by an accredited testing body and come with appropriate instructions for safe use. While it’s true that artificial intelligence can assist in diagnosis, there are still a number of questions surrounding its use. For example, should hospitals hire human radiologists as well as AI-based systems? And how much of a doctor’s job could be automated through artificial intelligence?

Regulating AI in Medical Devices

As technology evolves, the FDA evolves too. Regulatory requirements for AI in medical devices weren’t something as common as it is today. With the current FDA structure, AI and machine learning devices will need a premarket review even for software changes.

Over time the FDA plans to establish a “predetermined change control plan” that’ll require reviewing anticipated modifications to the software. This will minimize risks to patients and ensure compliance with regulations.

The FDA’s new guidelines are just another step in ensuring that medical device manufacturers remain compliant with regulations while also allowing them to incorporate innovative technologies into their products. As AI becomes more prevalent in medical devices, it’s important that regulatory agencies like the FDA keep up with technological advancements so they can continue to protect consumers from harm.

The FDA is working hard to ensure that medical device manufacturers comply with regulations while also incorporating innovative technologies into their products. The new changes make it clear that regulatory agencies like the FDA understand how technology is changing and are willing to evolve with it in order to protect consumers from harm.

The Future of Healthcare

Technology is constantly evolving. What has become normal today was unimaginable 30 years ago. Just think about how much healthcare can change in the future. The possibilities are endless. It’s an exciting time to be alive and see what new technologies will have an impact on healthcare. Whether it’s identifying and curing diseases or improving the time it takes to get test results, technology will continue to improve our lives. While there are plenty of benefits with advancements in technology, there are also risks that come along with them. With all these potential dangers, it’s important to have a governing body in a place like the FDA to ensure the safety of patients.

If you have any questions about your medical device, or need assistance creating it, contact DeviceLab today.

FDA Classification: Class III Medical Device Overview

What Type of Medical Device Holds a III Classification?

Previously we’ve discussed FDA Class I medical devices, which are the lowest levels of risks. But what about medical devices that are the riskiest or have the most unknown risk? The FDA regulates medical devices based on the risk-benefit profile. Medical devices with a higher risk profile or lower perceived benefits are classified as Class III medical devices.

Class III medical devices can be any type of device, including diagnostics. Class III devices commonly include products with incredibly innovative technologies, long-term implantables, and breakthrough medical devices. The FDA defines a class III device as a device with one or more of the following:

Used in sustaining or supporting life
Has considerable significance in preventing the impairment of human health
Presents a possibility of unreasonable risk of injury or illness

FDA maintains a higher level of control over class III medical devices. Class III medical device manufacturers must provide a substantial amount of data to the FDA prior to receiving FDA approval and provide continuous post-market data to the FDA to support the marketing of their device. Manufacturers of class III medical devices are typically subject to a “Premarket Approval Application” or PMA submission to FDA.

Premarket Approval Applications for Medical Devices

PMA submissions are a lengthy application process with the FDA. Manufacturers developing class III medical devices will need to have discussions with the FDA before submitting their applications. Most PMA submissions will require some level of human clinical data through a clinical trial. Prior to submitting a PMA, manufacturers will likely need to submit an investigational device exemption (IDE) to collect human clinical data.

Unlike the 510(k) application process, PMA submissions do not rely on the use of a predicate device. So all bench, pre-clinical, and clinical testing must support the safe and effective use of the product, rather than substantial equivalence. Class III devices and PMA submissions require expertise from many different disciplines because of the amount of evidence needed to support the device’s use.

FDA Approval of Class III Medical Devices

After receiving FDA approval for a Class III device, manufacturers are still subject to different requirements. In the approval letter, FDA may specify specific post-market requirements such as registry efforts, annual data submissions, or post-market clinical trials. Manufacturers will have to periodically submit reports to FDA about their class III devices. These reports are typically yearly reports called “annual reports” and include information like annual sales data, trending complaints, metrics on patients or usage, and a literature search. However, FDA may request annual reports quarterly or biannually.

DeviceLab’s Experience with Class iii Medical Device Design

If your organization is evaluating or developing a class III device, DeviceLab can help help you with design, prototyping, manufacturing, regulatory, and marketing to bring your product to patients and providers. Contact DeviceLab to schedule a consultation.

Discussing Ways to Take Your Medical Device From Prototype to A Regulatory Approval

What Are the First Steps to Take a Medical Device Prototype to Get Regulatory Clearance?

One of the most exciting moments for medical device developers is when their idea is brought to life through a prototype. After the first initial prototype, engineers will keep iterating the design and developing new prototypes. Because of the iterations in prototypes, this phase of medical device development is typically the longest. Prototypes can look like computer-assisted designs that will show a rotating image of the finished device or 3-D printed models, which are physical products that typically cannot perform functions. Once the engineers get closer to the final design, they will start building actual working units as prototypes and start testing the product.

User Needs and Design Inputs

Each iteration of a prototype is a good thing and essential to medical device development. With each new version of the device, the engineers are meeting more of the user’s needs and design inputs. User needs and design inputs are all of the device requirements for performance and safety. These requirements are defined prior to prototype development and guide all future iterations of the prototypes. Engineers will informally test prototypes to see if they are meeting user needs and medical device design inputs. Once engineers feel confident in a prototype’s ability to meet user needs and design inputs, then they will go into formal verification and validation testing.

Verification and Validation Testing

Verification and validation testing refer to a suite of testing that challenges the device to ensure the device performs as intended and reduced risks. The engineers will develop formal protocols with statistically significant sample sizes, defined acceptance criteria, and formal procedures for testing. The test cases in each protocol are designed to verify and validate that all user needs and design inputs are met. Verification and validation testing include bench testing, animal testing, and even human clinical trials. If defined as a user need or design input, verification and validation testing can include biocompatibility testing, sterilization testing, transit testing. If all acceptance criteria are met, the engineers can conclude that medical devices will meet user needs.

The bulk of any regulatory dossier will be the verification and validation test reports. Regulators want to review these reports to ensure all user needs and design inputs were tested, the test methods are acceptable, and the sample size is statistically driven. Engineers and medical device manufacturers should be careful about when they begin to formally start the verification and validation testing. Regulators are interested in reviewing test reports for the final finished medical device. It is important that all verification and validation testing is performed on the final finished medical device. The verification and validation testing are what will bring a prototype to a complete medical device with regulatory clearance.

No matter what stage of product development you are in, DeviceLab is here to help. DeviceLab has a specialized team of engineers and consultants who can answer your questions from prototype development, informal testing, or formal verification and validation. Contact DeviceLab today to schedule a consultation and learn more about our services.