At ComplianceAcuity we have an exceptional theoretical and practical grasp of FDA regulatory law.

We’ve prepared and received FDA clearance/approval for a wide variety of class II and III medical devices spanning at least six different FDA ODE Divisions, including strategic and tactful interface with FDA officials, to achieve successful marketing clearance using our proven GlobalReg® Compliance solutions and tools. We’ve also got specialists to handle various drug product approvals from FDA’s CDER.  Specifically, our hands on experience includes:

• 510(k) [traditional, abbreviated, special, and de novo]
• PMA
• IDE
• 513(g)
• NDA / ANDA / OTC Monograph

Some of the keys to the success indicated in our client testimonials are:

• FDA device classification and customized case analysis to define the anticipated FDA premarket roadmap for your unique business goals
• Concise guidance about essential supporting data (i.e., biocompatibility, shelf life, standards compliance, GMP, performance testing, etc., that will be required)
• Skillful review of your existing data to assess the adequacy and consult about foreseen problems
• Realistic data solutions if additional supporting data are needed
• Expert composition, assembly, and submission of the 510(k) per FDA’s latest requirements, including its new eCopy and Refuse-to-Accept policies
• Grass-roots interface with FDA on your behalf at all phases of the project
• Proven response techniques to avoid undue delays and promptly address FDA requests for additional information until FDA issues written clearance/approval.

Galvanizing our credentials, ComplianceAcuity consultants have achieved the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professonal Society (RAPS), a mark of distinction demonstrating mastery of applied medical device and pharmaceutical regulation.