Requirements and Exemptions
Paladin Medical will assess submission requirements for your new medical product to optimize your regulatory strategy. FDA has exempted hundreds of medical devices which formerly required a 510(k). Yet Class I devices may still require a submission if the new product falls outside the technological similarities of the predicate devices or FDA’s original regulation description. Some Class III devices may be cleared by 510(k), and some Class II devices can require a pre-market approval if FDA determines that the new technology introduces safety issues that have not been adequately addressed by testing.
FDA publishes hundreds of guidance documents on their website, and recognizes a multitude of international and national standards. We'll help you make sense of it all for your new product.
For specific experience details and project profiles, please see the Paladin Medical Profiles in Success (pdf).
Paladin Medical Key Services
• Sourcing for prototype testing, test lab selection, animal and clinical trial protocol design, audits, and data analysis.
• First contact with FDA.
• Clinical data and technical documentation support for PMA submissions.
• 510(K) preparation and submission, streamlining time and cost.
• Official Correspondent to the FDA through the review process.
• Internal data audits or pre-approval gap analysis for Bioresearch Monitoring and QSIT inspections.
• Supplements and annual reports for PMA products.
©2008 Paladin Medical, Inc.
Pre-Market Submissions
US FDA Pre-Submission Meetings
Pre-submission meetings with the FDA ensure that new product development efforts will result in a satisfactory submission. However, meeting with FDA requires careful preparation. Paladin Medical, Inc. will organize and plan your first contact with FDA to give your product the best regulatory position possible.
Your first meeting with FDA must express your company’s professional position and sound technical judgment. Being unprepared for an FDA meeting can be disastrous. The 1997 FDA Modernization Act will put increasing pressure on FDA services, making the time available by FDA for meetings competitive. Paladin Medical will outline your proposal, contact the right people at FDA, and set an agenda for your face-to-face or teleconference meeting with key FDA personnel.
