The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after they go to market.

Two departments within the FDA ensure U.S. consumers have access to the safest medications and medical devices in the world:

Although the CDRH primarily regulates devices, the CDER may have jurisdiction over certain combination products involving both a drug and a device.

An FDA approval for a drug or device means that it has been reviewed by CDER and/or the CDHR and determined to be effective and safe for its intended audience.

The journey from discovery to FDA approval can take 10 to 15 years for a new drug, and 3 to 7 years for a new medical device.

This article reviews the primary development and approval phases that a drug or medical device must undergo before being approved by the FDA.

However, it’s worth noting that the number of phases and the exact pathway to approval can change depending on the drug or device being tested.

Can the FDA approval process for certain drugs or medical devices be fast-tracked?

It’s possible for a drug’s approval process to be accelerated or “fast-tracked” if the new drug treats serious conditions and fills an unmet need. The FDA defines an unmet need as providing treatment where none exists or that may be better than current therapy.

The FDA also offers a fast-track process for medical devices called the “Breakthrough Devices Program.” The program streamlines the approval of devices that provide more effective treatment or diagnosis of life threatening or debilitating health conditions or diseases.

During phase 1, research for a new drug or medical device typically begins in a laboratory.

Drug development

At this stage of development, thousands of different drug compounds may be potential candidates for development as a clinical treatment. Researchers conduct early testing on potential candidates to determine which ones are promising and warrant further investigation.

Experimental testing on promising drug candidates examines:

  • how the drug is absorbed, metabolized, and excreted
  • its potential benefits and mechanisms of action
  • its dosage
  • the best form to give the drug (topical, oral, or injection)
  • side effects or adverse events
  • how it affects different groups of people (such as by gender, age, ethnicity)
  • how it interacts with other drugs and treatments
  • its effectiveness compared with similar drugs

Device development

The development process for a device typically begins when a researcher identifies a medical need that has not yet been met. They then create a “proof of concept” for a new device.

A proof of concept outlines all the steps needed to determine whether the device is feasible. Concepts that show promise move to the next stages of development.

During phase 2, promising drugs and devices undergo laboratory animal testing to determine their safety.

Drug preclinical research

Before testing drugs in people, researchers first test them in vitro (test tube) and in vivo (living animals) to determine dosing and whether they have the potential to cause harm. This is referred to as “toxicity.”

Researchers then review their findings to determine whether this drug is safe to be tested in people.

Device preclinical research

In this phase, researchers build a prototype of the device and test it in a laboratory. The goal is to determine whether the prototype is safe for human use. Further refinements may be made at this stage.

During phase 3, drugs and medical devices are tested on people to determine their effectiveness and safety.

Drug clinical research

Clinical research for a new drug involves designing clinical trials that will answer research questions and objectives. Researchers decide:

  • who and how many people will participate (selection criteria)
  • duration of the study
  • how the drug will be administered and at what dosage
  • what data will be collected
  • how the data will be evaluated and analyzed

Clinical trials follow a standard series from early, smaller-scale studies to later-stage, large-scale studies.

Medical device clinical research

The approval pathway for a medical device depends on its risk classification.

The FDA uses a Class I, Class II, and Class III classification system for medical devices. The system is based on the level of control needed to ensure safety and effectiveness.

For example, a device placed in a Class 1 category would be subject to the least regulatory control, while a Class III device would be subject to the most regulatory control.

During this phase, applicants compare their proposed device to similar marketed devices and make their case for which class their product should be placed in.

The device then goes through a premarket approval (PMA) process to determine the safety, effectiveness, and regulatory requirements of the product.

During this phase, the FDA examines all of the research data related to the potential new drug or medical device and determines whether to approve or not to approve the product.

Drug FDA review

If preclinical and clinical research prove that a drug is safe and effective for its intended use, a developer can file an application to market the drug.

In their application, a developer must include everything they know about the drug, including:

  • a proposed label
  • directions for use
  • potential drug misuse information
  • patient information
  • directions for use
  • data from studies outside the United States
  • review board compliance information

The FDA then evaluates all submitted application data and makes a yes or no decision to approve the drug.

The FDA approval process is lengthy and involves a team of medical experts. Each team member conducts a full review of their assigned portion of the application. The FDA team members may travel to clinical study sites to conduct routine inspections.

The team project manager then compiles individual reviews from all team members into a final package that becomes the document for FDA review.

Medical device FDA review

If medical device developers have sufficient information on their device’s safety and effectiveness, they can file an application with the FDA to market the device.

The FDA often consults with an advisory committee of medical experts to decide whether to approve the device or request additional information.

During this phase, the FDA closely monitors new drug and medical device products that have been approved for use by the public.

Drug postmarket safety monitoring

Clinical trials unearth important information about a drug’s safety, effectiveness, dosage, and side effects. However, despite the FDA’s rigorous approval steps, it’s impossible to have complete information at the time of a drug’s approval.

Oftentimes, the safety and side effects of a product may emerge over months or even years after it has been on the market.

For this reason, the FDA monitors and reviews all reports of prescription issues. They can choose to add precautions to the label or alter dosage information. In the case of serious issues, they can even choose to remove a product from the market.

Medical device postmarket safety monitoring

Although premarket clinical trials provide important information about the safety and effectiveness of a medical device, new safety concerns may emerge after the product is on the market.

As a result, the FDA conducts routine inspections of medical device manufacturing companies in the United States. These inspections may or may not be prompted by a reported issue.

The FDA also has several reporting programs that consumers and health professionals can use to report problems. These include:

  • MedWatch: This program provides a gateway for reporting issues with drugs or medical devices. People can also subscribe to MedWatch safety alerts for up-to-date information about a drug or device.
  • Medical Product Safety Network (MedSun): This program monitors the safety and effectiveness of medical devices. Each month, MedSun releases a consumer newsletter that details important information about medical device safety.

The FDA can shut down manufacturing companies if standards are not met.

The FDA oversees the regulation of drugs and medical devices in the United States.

Although the FDA approval process is lengthy and complex, it offers numerous benefits to the public. For example, it:

  • ensures the safety and effectiveness of all FDA-approved medical devices and drugs
  • prevents the marketing of unproven medical products or devices
  • upholds high standards for the manufacturing of drugs and medical devices
  • provides ongoing monitoring of FDA-approved drugs and devices for safety and quality

The FDA also provides accelerated approval programs for certain drugs and medical devices, which can help bring important products to market sooner.