FDA Approval Process

For pharmaceutical and medical device companies, the FDA approval process and clearance process ensures that their products are safe and effective

The FDA's main job is to evaluate drugs and medical devices before they are sold in the market. The FDA approval process, though meticulous, provides companies with stringent mechanisms for evaluating drugs and devices that are safe to use for humans. There are several rounds of trials for both medicines and devices before they are termed safe and effective for humans.

How to Successfully Complete an FDA Inspection

Free Resources

Select all the resources you’re interested in downloading

The FDA Approval Process for Drugs

The stringent FDA approvals process is a lengthy, time-consuming process that may span several years for completion before a pharmaceutical company is able to market a product. In this duration, companies must be prepared to incur not only the cost of the drug that actually successfully passes clinical trials but also several other drugs and devices that fail the FDA approval process. There are several phases that a drug or a device must go through before attaining FDA approval. These include:

Clinical Trials - Phase I

If the drug passes pre-clinical trials, the next step is to move on to the clinical trials where the company tests the drugs on a small number of volunteers, usually fewer than 100 individuals. The main objective of this first phase is to assess the tolerance of the drug, its reaction in the human body, and the correct dosing. This entire phase typically takes one year for completion.

Clinical Trials - Phase II

Phase II spans to about two years in which 100-300 volunteers are monitored to assess a drug's effectiveness. If the compound is well tolerated in the volunteers, it is then tested for effectiveness on a small number of patients suffering from the targeted diseases. The main objective of this phase is to see if the drug actually works and also determine its short-term effects.

Clinical Trials - Phase III

Phase III is an extension of Phase II in which larger number of patients are involved to evaluate the effective of the drug as well as its side effects. The phase lasts approximately three years during which approximately 1,000-3,000 patients are evaluated. The FDA approval process is based on the results that are extracted from the Phase III of the clinical trial.

Companies then submit an application for approval to the FDA which may take up to two and a half years for completion. Once FDA approval is obtained, the drug is then made available on the market after which the company will continue to report cases of adverse reactions and other clinical data to the FDA.

The FDA Approval Process for Devices

The FDA approval process for medical devices is not as stringent as for medicines or drugs. However, medical devices are used in real-time where it is imperative for equipment to perform without any risk of failure or hazard. Since medical devices can be basic, such as the general equipment used in the hospitals, clinics, etc., or advanced devices that are specifically used during operations or check-ups, it is important to classify the equipment according to the nature of their operation. This also allows general guidelines to be drafted for the FDA approval process that are particular to the devices' specifications. The FDA approvals process is divided into two types of classes for devices that are explained below:

The FDA Approval Process for Class I Devices

Class I devices must meet standards relating to manufacturing, labeling, surveillance (post-market), and medical device reporting. Adherence to these standards can be achieved through effective FDA approval processes. These controls are considered general and Class I device manufacturers will rarely be subject to a formal FDA review before their Class I device is cleared for market.

The FDA Approval Process for Class II Devices

In order for Class II medical device manufacturers to obtain FDA clearance, additional controls - in conjunction with the aforementioned general controls --must be adhered to. These types of controls can include design controls, performance standard requirements, and surveillance programs (post-market) which are helpful in attaining FDA approval. In general, Class II device regulatory professionals will need to file a 510k submission to establish proof that the device is "substantially equivalent" to devices that are currently being sold in the market.

FDA Approvals Process Management

The MasterControl suite provides sustained compliance with the FDA approvals process and integrated quality management by supplying a centralized, easy-to-use solution that efficiently and effectively controls documentation and GxP processes. MasterControl's quality management software has been specifically developed to serve the compliance needs of regulated companies in life science industries such as:

  • Pharmaceutical
  • Medical Devices
  • Biotechnology
  • Blood / Tissue
  • Laboratories
  • Contract Organizations

For More Information on the FDA Approvals Process

The MasterControl team is here to answer your questions and get your company's products on the right track toward FDA approvals process. Call 800-825-9117 to speak with a MasterControl team member or contact MasterControl for more information.