fda establishment registration

FDA Clearance & Post-Market Setup Services – XPRO AMERICA

After successfully navigating the 510(k) or De Novo submission process, medical device manufacturers must secure their FDA clearance certificate and ensure ongoing compliance with post-market requirements. Timely clearance and accurate post-market setup are essential for legal distribution and long-term regulatory success in the U.S. market. At XPRO AMERICA, we provide [...]

Premarket Approval (PMA) Applications for Class III Devices – XPRO AMERICA

Premarket Approval (PMA) is the FDA’s regulatory pathway for high-risk Class III medical devices, which require extensive scientific evidence demonstrating safety and effectiveness before marketing in the United States. Unlike 510(k) or De Novo submissions, PMA applications often involve clinical study data and rigorous review processes. At XPRO AMERICA, we [...]

Medical Device Registration & Listing Compliance – XPRO AMERICA

All medical device manufacturers, repackers, relabelers, specification developers, and initial importers must comply with FDA regulations for establishment registration and device listing under 21 CFR Part 807. Annual registration ensures FDA oversight of facilities marketing devices in the United States, while device listing identifies each medical device available in the [...]

De Novo Device Classification & FDA Support – XPRO AMERICA

The De Novo classification pathway is designed for novel, low- to moderate-risk medical devices that do not have a predicate device for 510(k) submission. This pathway allows manufacturers to obtain FDA marketing authorization by demonstrating safety and effectiveness while establishing a new device classification. At XPRO AMERICA, we provide expert [...]

Annual & Ongoing FDA Compliance Services – XPRO AMERICA

For companies regulated by the U.S. Food and Drug Administration (FDA), compliance is not a one-time process but an ongoing responsibility. Each year, manufacturers, distributors, importers, and other regulated entities must renew their establishment registration and update product listings to remain in good standing with the FDA. In addition, regulatory [...]

510(k) Premarket Notification & Clearance Support – XPRO AMERICA

The 510(k) Premarket Notification is the primary FDA submission pathway for most Class II medical devices. It demonstrates that a new device is substantially equivalent to a legally marketed predicate device. Proper preparation, documentation, and FDA interaction are critical for timely clearance and market access in the United States. At [...]

US FDA Registration

US FDA Registration To register with the U.S. Food and Drug Administration (FDA), the specific requirements and processes will vary depending on the type of business and the products or services you provide. Here is a general overview of the FDA registration process: 1. Determine Applicability: Identify whether your business [...]