US FDA Approvals consultantsFDA regulatory compliance is key to the single largest, most valuable marketplace in the world.

FDA regulatory compliance usually includes:

  1. QSR, the quality system regulation
  2. Compliance to reference or performance standards
  3. FDA GMP, good manufacturing practice
  4. Compliance with Guidance Documents, and
  5. FDA 510(k) submissions resulting in market access.

Horizon Phoenix experts have demonstrated regulatory compliance through hundreds of FDA 510(k) applications on product such as high volume low cost injection molded parts to drug/device combinations to in vitro diagnostic test kits.

If your issues are complex or you want some assurance that you are headed in the right direction, we can organize and conduct FDA regulatory determination meetings, pre-IDE, request for designations and collaboration meetings where you sit with FDA regulatory compliance officials explain what you want or need to do and they offer their insight and comments.

While you are considering a FDA 510(k) or PMA submission, remember these are only one layer of FDA regulatory compliance.

Other issues to consider include FDA regulatory compliance guidelines:

  • 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 (GMP)
  • current Good Laboratory Practices (GMP)
  • Consensus and/or Performance Standards
  • Implementation of the FDA Quality System Regulation (FDA QSR)

FDA compliance can used as a great starting point for CE Marking under many EU directives including MDD, IVDD and AIMDD. If you organize your regulatory compliance activities properly you can demonstrate compliance to many jurisdictions. If you want that all important CE Logo too, Horizon Phoenix can help!

Horizon Phoenix experts, 25 years experience in putting clients
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