Product Registration -FDA 510k
Products must be cleared by the FDA and listed before being introduced into the US market. In many cases manufacturers and distributors need to submit a 510k Premarket Notification or Premarket Approval document to the FDA, obtain market clearance, and follow and stay in compliance with QSR regulations when marketing and distributing products. Sigma services for medical device registrations, 510k submissions, and FDA regulatory affairs will help you expedite in a cost effective manner your product approval process, product listing, business registration, and compliance with FDA regulations.
Safety and Effectiveness
Products need to be safe and effective. Manufacturers must ensure their products are developed, manufactured and used in a safe and effective manner. Performance data obtained from product testing must show adherence to applicable FDA recognized consensus standards. The type of testing depends on the nature of the product, intended use, components and the product interaction with the patient and the user. Our team of experts will evaluate your product and based on regulations, will determine product classification and compliance requirements for approval.
Products need to be developed and manufactured under a sound quality management system. Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). Sigma compliance and quality personnel will do a GAP analysis to evaluate compliance with cGMP regulations and ISO13485 standards, and direct you in the proper path for QMS implementation.