How to Get a Medical Device Approved by the FDA
January 9, 2018
Tips for Getting FDA Approval on a New Medical Device
Some devices must be submitted and approved before they are in use
Medical devices are becoming increasingly important in clinical practice. Today’s Medical Developments predicts that the global manufacturing of medical devices will grow at a compound annual growth rate of 11.6 percent, reaching $40.8 billion by 2018. The top three factors that are driving the growth of medical devices in health practice include:
- The demand for more advanced and personalized treatment
- Increased availability of healthcare
- Aging population
The advancement of other technologies, including telecommunications, digital imaging and robotics, will also fuel greater growth to improve efficiencies and outcomes. All indications are that the use of devices will continue and potentially increase—promising news for designers and manufacturers of medical devices.
Before distributing the device, however, you must go through an FDA medical device approval or clearing process. If you’re new to the medical device market, the term “FDA approval” can be stress-inducing. Uncovering the steps you need to take can help alleviate any panic you may be feeling and put you on the road to profiting from your invention. Read on to learn more about the medical device approval process.
What is the first step of the FDA approval process?
You must determine if your device is exempt from premarket notification. Devices that are classified as “low-risk” do not have to be reviewed by the FDA before they’re marketed.
There are three classifications the FDA uses for medical devices:
- Class I devices are low-risk,
- Class II are higher risk and require some special controls, and
- Class III are for high risk devices that are considered life supporting.
Class I devices and some Class II devices that do not require FDA approval and premarket notification are called 510exempt. Devices that are 510(k)-exempt can be marketed without FDA clearance. For guidance on whether your Class II device is exempt, the FDA points to Procedures for Class II Device Exemptions from Premarket Notification: Guidance for Industry and CDRH Staff.
The FDA has a product classification search function that allows you to look through a database of existing, legally marketed devices to help determine your device’s classification.
Clearance is given to devices that are substantially equivalent to devices that are currently in legal use in the market. In order to support this claim, a distributor must submit a 501(k) form along with studies or other supportive information that shows there is a similar device that is currently in use. If your new device is identified as substantially equivalent, it will be given the same classification as the equipment that’s on the market and will receive “FDA clearance”.
How do I get my device approved by the FDA?
Class III medical devices may present a potential risk of illness or injury, and therefore must go through a more rigorous FDA approval process. To be approved, the device must be submitted to the FDA with supportive information to demonstrate its safety and effectiveness. A completed Premarket Submissions coversheet and six copies of a bound report with details about the device must be included in the premarket approval (PMA) application.
Here are the required elements:
- Your name and address
- Table of contents with page number and volume of each item referred to in the contents:
- Separate sections of nonclinical laboratory studies and clinical investigations involving human subjects
- Trade secret or confidential commercial or financial information
- A summary section that describes an overview of the data with major points highlighted, including:
- Device description, how it functions and scientific concepts that help describe its effective use
- The manufacturing process, including methods, facilities and controls; include packaging and storage information
- Alternative use and whether there are other similar Class III devices in use; including marketing history, where it’s used
- Separate sections of nonclinical laboratory studies with human subjects
- Reference any clinical laboratory studies with human subjects and cite whether the studies were in compliance with the Institutional Review Board, informed consent and device exemptions regulations.
- Conclusions drawn from the studies
- Complete description of the device and pictorial representations of the following:
- Each function, component or ingredient
- Properties of the device, including diagnosis, preventive or treatment properties
- How the device operates
- Methods, facilities and controls used in the manufacture, processing, packing storage and if appropriate, installation of the device
- Reference any performance standard(s)
- Technical sections
- Result of nonclinical studies
- Results of clinical investigations involving human subjects including protocols, number of investigators, subjects, etc.
- The PMA should be supported by data from two or more investigators, or there should be an explanation as to why a single investigator was sufficient
- A bibliography of all published reports not already submitted
- One or more samples of the device and its components
- Copies of the proposed labeling
- An environmental assessment
- A financial certification or disclosure statement
- Any other information that the FDA requests
After receiving this submission, the FDA will perform a rigorous review of the PMA application before approving or rejecting the device. Read the FDA’s PMA Application Contents for more about what should be contained in a PMA. Acceptance and Filing Reviews for Premarket Approval Applications is another helpful resource from the FDA that can help you get your Class III medical device approved.
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