Medical devices in the US are classified into three classes: Class I are the lowest risk devices and Class III the highest risk devices. The various classifications and requirements are detailed in the Code of Federal Regulations (21 CFR 820). Most Class II devices are subject to a Pre-Market Notification procedure and most Class III devices are subject to a Pre-Market Approval process. All medical devices have to be listed with the FDA (Medical Device Listing) and all companies intending to market their medical devices in the US must notify the FDA of their intention and be registered (Establishment Listing), prior to the introduction of their products into the US market . Regardless of the product classification, Quality Systems Regulations (QSR) compliance is always required.

Qserve provides help to medical device companies who are seeking regulatory approval for their products in the US. Qserve Consultants have a wealth of experience in the preparation of regulatory submissions required to obtain FDA marketing clearance and have built strong relationships with the FDA. We can advise on the best strategies for filing and compliance, and help you avoid the common pitfalls and delays. Qserve can help you bring your product to the market faster, minimizing the time and costs involved, and maximizing your product revenues.

• 510(k) or Pre-Market Notification

This is the primary mechanism by which medical devices are accepted to the market in the US. This notification is made under section 510(k) of the Federal Food, Drug and Cosmetic Act, of the intention to manufacture a medical device for use in the US market. Its purpose is to demonstrate to the FDA that the device to be marketed is “substantially equivalent” to another that was on the market prior to May 28, 1976 or a device that has already been accepted through the 510(k) submission process. Most devices, unless they employ novel technologies or applications, can be submitted for review under this process. The FDA will require data to back substantial equivalence claims, descriptive data and performance data, to support this type of submission.

There are a number of variations to this process, e.g. the “Abbreviated 510(k)” for products conforming to agreed standards or the “Special 510(k)” for changes to existing devices.

• IDE or Investigational Device Exemption

New devices cannot be trialed in human subjects without prior permission from the FDA and an Institutional Review Board (IRB). The application filed for this approval is called an Investigational Device Exemption (IDE). It allows for the investigational medical device to be used in a clinical study to collect safety and effectiveness data, in support of a Pre Market Approval (PMA, see below) application or a Pre Market Notification, 510(k) submission to the FDA.

• PMA or Pre-Market Approval

This involves the formal approval of the FDA of the safety and effectiveness of the medical device based on valid device-related scientific data and rational, rather than just comparison as in the 510(k) process. This process mostly applies to Class III medical devices with the most novel and complex technologies and applications are subject to rigorous scrutiny by the FDA.

For existing Class III devices, any changes to the product, process or indications for use must be approved by the FDA through a “Pre-Market Approval Supplement” submission.

Whichever of the above applies to your medical device Qserve global Consultants will successfully guide you through the submission. We advise on, or carry out the following activities on your behalf:

• GAP analysis
• Regulatory document preparation and submission (e.g. 510(k), IDE, PMA, design dossier)
• Quality system development, implementation, management, auditing and training (FDA/QSR, GMP, GLP, GCP, ISO 9000,and ISO 13485 compliance)
• New technology assessment
• Business development
• Medicare reimbursement

Qserve America acts as an interface between your company and the FDA, receiving and responding to their questions. We can also be of assistance in scheduling and attending inspections conducted by the FDA. Should you require more information about this, please click on the link to US Agent and Official Correspondent.

For more information, please download our flyer: 510K