Tools & Templates

Cancer is constantly evolving and so are we. Download this early-phase oncology fact sheet to learn how we help MedTech and biotech companies that are providing next-generation treatments to cancer patients.

You're submitting a Traditional 510(k) application and you're wondering how long the approval process will take. Download our Traditional 510(k) FDA Timeline Infographic to learn more.

Want to learn how long a breakthrough device designation application submission process takes with the FDA? Download this free infographic breaking down the timeline of a breakthrough device designation application for an emerging product.

Benefit-risk assessments are important tools that help regulators determine whether or not the benefits of your device outweigh the risks.

Does your software qualify as a medical device? This resource will help answer this question and also provides tips on how to perform a proper clinical evaluation of your software device.

In Vitro Diagnostic (IVD) devices often include an entire additional set of regulations on top of general medical device regulations.

Quality Management Systems (QMS) are important for the efficient management of a product.

Humanitarian Device Exemptions (HDEs) are for devices that are intended for diseases that affect small populations of people.

The De Novo review pathway provides an alternative pathway for novel devices to attain FDA approval.

Adequate design controls allow you to effectively manage the development of your device, ensure your product meets expectations, and prevent potential issues or recalls in the future.

Pre-Submissions(Pre-Subs) are a part of the FDA Q-Sub program, used to help gain FDA feedback before a regulatory submission.

Labeling is important in the distribution and handling of medical devices. Use this resource to gain an overview of 21 CFR 801, which provides FDA’s regulations and expectations for labeling medical devices. ‍

Breakthrough Device Designation (BDD) is a unique regulatory pathway that allows for novel technologies to receive a prioritized and expedited review by the FDA.

What is a medical device? What are the different classifications for a medical device? This resource provides a first look at the different types of medical devices.

What is good risk management, and how can your company benefit from it?

How should a regulatory assessment be performed? Using this resource, you will learn how to use FDA databases effectively and efficiently.

Does your medical device qualify for a Traditional, Special, or Abbreviated 510(k)?This resource provides an in-depth look into each type of 510(k), the requirements for an FDA submission, and tips on how to improve your submission quality. ‍

Good Manufacturing Practices (GMPs) are regulations that ensure the safety, purity, and effectiveness of drugs, medical devices, food, and more.

The Premarket Approval (PMA) pathway is the most stringent of the FDA regulatory pathways.