USFDA Market Clearance  

Simply getting US market access faster - no jargon filled pages laced with flow charts!
Ask us how...

The USFDA does not approve products, the agency merely grants a company US market access and the faster you receive US market access the better is your product's chance of success, as the US is the single largest, most valuable marketplace in the world. Depending upon your product's risk classification, your claims and the type of product you are manufacturing, there are several USFDA regulatory processes that must be considered.

Horizon Phoenix experts have successfully filed hundreds of 510k applications from high volume low cost injection molded parts to drug/device combinations to in vitro diagnostic test kits. We know the processes, the options and the deal breaking issues. We can lead you through the preparation and submission of USDFA market access applications such as:

• 510k (traditional, abbreviated or special)
• Premarket approval (PMA) for more complex or high risk products (risk
  class III), or
• Investigational device exemptions (IDE)

Want to establish more clarity with FDA officials? Horizon Phoenix has organized and managed several hundred determination meetings, pre-IDE, request for designations and collaboration meetings where you sit with FDA officials explain what you want or need to do and they offer their insight and comments.

Is your device innovative or leading edge? Horizon Phoenix has successfully filed drug/device combinations, long term cardiovascular implantables, digital mammography, new chemical entity and even received USFDA clearance for devices previously considered merely holistic.

While you are considering a 510k or PMA submission, remember these are only one layer of USFDA compliance. Other issues to consider include: · Inherent Safe Design of devices/products
· Process Validation
· Software Validation
· Design Transfer Validation
· Comprehensive Design History Records
· Implementation of General Controls and/or Special Controls
· HACCP based in process tests, checks and final product release
· current Good Manufacturing Practices (cGMPs)
· current Good Laboratory Practices (cGMPs)
· Consensus and/or Performance Standards
· Implementation of the Quality System Regulation (USFDA QSR)

Don't be caught short - ask us about being in full and unimpeachable compliance with USFDA requirements. Horizon Phoenix experts have been there before, we know what to expect, we know what works and what doesn't.

Horizon Phoenix experts, 25 years experience in putting clients on the cutting edge and keeping them off the cutting block!

Ask Us How!...