FDA submissions

Maytal experience in the Medical devices and IVD field as also in the US market, allow us to support medical device manufacturer in the definition of a global regulatory and reimbursement strategy for the USA market.
Based on the needs of the company Maytal can supply:
  • General background on the FDA regulations and applicability to the company devices that could to be potentially sold on the US market
  • Background on the reimbursement rules and Identification of the proper CPT codes for the company devices that could to be potentially sold on the US market
  • Device classification determination for the company devices that could to be potentially sold on the US market
  • Medical device registration
  • Labelling requirements analysis
  • US Agent Representation for foreign manufacturers
Unique Device Identification (UDI) requirements for medical devices have been implemented by the US Food and Drug Administration (FDA). The FDA issued the final Unique Device Identifier (UDI) Rule and implemented into the US Federal Register on 24 September 2013.
Manufacturers must meet UDI requirements as part of US market compliance.
UDI has impact not only on the labels, it is not only a simply barcode on the label, but it may have impact to the correct device identification on the market, and how the product could be sold and distributed.
Maytal can support the Medical device and IVD manufacturers through:
  • Gap assessments for UDI compliance, through product labelling analysis
  • UDI training and project management, working with the company staff to define how to improve UDI requirements and minimize its impact.
  • Helping to identify appropriate accredited UDI agencies on behalf of the company
  • Recording into GUDID database the products involved in UDI
  • Assisting and training the company resources to allow to properly managed GUDID database
  • Assisting the company to incorporate UDI processes into the quality management system and production operations.