REU Associates
www.REUAssociates.com

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Office: 440.840.0949
Fax:     440.953.9789

FDA Submissions

REU Associates Inc. will develop your regulatory submission strategy and implement your regulatory submission activities pertaining to Premarket Notifications 510(k), Premarket Approval Applications - PMAA, Investigational Device Exemptions IDE, Request for Product Classification 513(g), and facility registration and device listing.

We will write and submit to FDA, on your behalf, the pertinent regulatory submissions which address your business requirements.

510(k) Determine which is most appropriate for your business:

  • Traditional
  • Abbreviated
  • Special

PMAA (Premarket Approval Applications)

  • Modular
  • Traditional
  • Streamlined
  • PDP (Product Development Protocol)

IDE (Investigational Device Exemptions)

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