FDA Approvals Process

For medical device companies the FDA approval process and clearance process will ensure that their products are safe and effective

For Class I and some Class II devices simple controls will suffice for FDA clearance. For medical device companies that produce Class III medical devices a premarket approval (PMA) will be required before the device can be marketed. Complying with best practice guidelines helps achieve continuous FDA approval for regulated products and requires a secure yet robust software solution that can deliver continuous validation.

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The FDA Approvals Process for Class I Devices

Class I devices must meet standards relating to manufacturing, labeling, surveillance (post-market) and medical device reporting which can be achieved through efective FDA approvals process. 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 Approvals Process for Class II Devices

In order for Class II medical device manufacturers to obtain FDA clearance, additional controls--in conjunction with the general controls mentioned in the Class I cleared section--must be adhered to. These types of controls can include design controls, performance standard requirements, and surveillance programs (post-market) which will help in attaining FDA approvals process. In general, Class II device regulatory professionals will need to submit a 510k if proof can be established that the device is "substantially equivalent" to devices that are currently being sold in the market.

Maintaining FDA Approvals Process

The MasterControl suite provides sustained compliance with 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 formulated 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.