It is crucial in ensuring that new drugs and medical devices introduced to the public are safe, effective and result in the intended medical outcomes. However, the process can pose a significant challenge, especially for emerging life sciences and other technology startups with limited resources. Crowley Law LLC understands the complexity of FDA regulations and is dedicated to helping life sciences and other technology companies meet profitability and public safety objectives with their new drugs and medical devices.
Having great science and novelty alone is never enough to build a thriving life sciences or other technology company. As a device sponsor, you must ground your science in a practical understanding of what it takes to satisfy FDA requirements. Most importantly, you should know how to navigate the premarket approval (“PMA”) process for new devices and the 510(k) process for devices deemed “substantially equivalent” to an already approved device.
In most cases, you will have to perform clinical studies to support your PMA or 510(k) application. However, you must first submit an investigational device exemption (“IDE”) before conducting these clinical studies. An IDE allows a medical device to be used in clinical research, exempting it from certain PMA requirements and allowing researchers to gather data on its safety and effectiveness.
The IDE process is designed to ensure that a clinical study on a medical device is well-designed, the anticipated benefits to human health outweigh the risks and appropriate safeguards are placed to reduce risks to human life. Therefore, as a life sciences or other technology company developing medical devices, you will be constantly engaged in the IDE process to successfully introduce your novel products into the national market.
Medical devices vary widely and so do the regulations regarding their testing. For instance, in vitro diagnostic medical devices are usually low-risk and minimally invasive, which means they have less stringent pre-marketing and testing approval requirements than in vivo diagnostic medical devices. The FDA differentiates exempt devices and the underlying regulations into three main classes:
These medical devices pose the lowest risk and are exempt from the FDA premarket approval and notification requirements. However, manufacturers must still comply with baseline general controls, including registration, manufacturing, labeling and device listing requirements.
They present a moderate risk to human health and safety. While these medical devices are subject to the same general controls as Class I devices, they may require 510(k) approval prior to marketing. Note that only a small percentage of 510(k) applications require clinical data for support.
These pose the highest risk and generally require both the PMA and premarket notification (“PMN”) from the FDA before marketing. In most cases, these medical devices require evidence from animal studies and clinical trials to evaluate the relative safety and effectiveness for human subjects. Thus, most class iii devices require IDE approval.
Medical devices can also be classified into two groups based on the level of risk they present:
If you deem a medical device to pose a significant risk, you must file an IDE and obtain FDA approval before proceeding with clinical trials. You can review the FDA regulations to assess if your medical device qualifies as a significant risk device.
Non-significant risk medical devices require filing an abbreviated IDE but do not require FDA approval. In such cases, you only need to obtain approval from the institutional review board (“IRB”) at each institution where the investigation is being conducted. Note that a device that is otherwise considered to pose a nonsignificant risk may fall in the significant risk category if its proposed use presents a novel significant risk, such as extending surgery time.
For some low-risk devices, the FDA allows clinical research without Federal filings or additional approval. The most common exempt devices include:
It takes a maximum of 30 days for the FDA to approve or reject your application. While there is no standardized form for IDE applications, the FDA provides guidance on the formatting guidelines and what information should be included. Some of the application requirements include:
The IDE must also include additional information about the investigational plan, including:
It is imperative to seek and receive early feedback from the FDA about the PMA, 510(k) and IDE processes. This can improve the quality of your IDE submissions, shorten review times and streamline the development process. The FDA has created multiple pathways to allow sponsors of medical devices to participate in early conversations and receive meaningful feedback. Here are some of the pathways you should know:
You can request study risk determinations to obtain FDA guidance on whether your proposed study is exempt from an IDE or if it poses a significant or non-significant risk. You can find detailed guidance from the FDA here.
These meetings are appropriate when you wish to familiarize the FDA with a new device or to provide an overview of device development when multiple submissions may be planned for the coming year. The FDA does not give feedback during such meetings, but you can leverage the pre-submission or early collaboration meetings process to receive feedback.
The FDA encourages new sponsors or those proposing novel technologies or processes to use the pre-submission process. If you fit this description, you can use the procedure to request and receive formal feedback on its IDE request from the FDA in writing or via telephonic or in-person meetings.
These meetings are established to allow the FDA to provide early feedback to medical device sponsors on the proposed bench/animal testing and clinical trial design. You can either have a determination meeting when anticipating a PMA submission or an agreement meeting when investigating a class iii device and intending to submit a 510(k) request.
To obtain further information on how you can leverage early feedback from the FDA, you can go through the agency’s “Requests for Feedback and Meetings for Medical Device Submissions” report.
New medical devices present a substantive risk to patient safety, warranting FDA oversight of device development and marketing. As a life sciences or other technology company, you need to understand FDA procedures to secure IDE approval and ultimately smoothen the pathway to market. Crowley Law LLC has an extensive network of experienced FDA consultants to help you navigate the underlying complexities. Some of our pertinent services include:
We help life sciences and other technology companies ensure their medical devices and clinical studies comply with all relevant FDA regulations.
Our team of FDA consultants helps device sponsors determine their devices’ correct classification (Class I, II or III) and whether an IDE is required or if the devices qualify for different regulatory pathways.
We help prepare and review IDE applications to ensure they meet all FDA requirements. We also help our clients ascertain that all required documents (e.g., informed consent forms and investigator agreements) comply with FDA guidelines.
We can liaise with the FDA during the IDE submission process, answering queries, negotiating on behalf of the sponsor and ensuring that any deficiencies identified by the FDA are promptly addressed.
We assist in organizing and participating in pre-submission meetings with the FDA to gain insights and feedback before submitting the full IDE application.
An IDE study is a clinical investigation that is conducted to collect safety and effectiveness data for a medical device not yet approved by the FDA for general use.
Once the FDA receives a complete IDE application, the agency is required by regulation to respond within 30 days.
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