Services

Establishment Registration and Device Listing

The FDA requires all entities that are involved in the production and distribution of medical devices intended for use in the United States to register annually with the FDA. This process is known as establishment registration. Many of these entities will also be required to list their devices. Lloyd and Bush can perform establishment registration and device listing.

Premarket Notification (510(k)) Assistance

Have a product that you want to market but not sure how to get started? Lloyd and Bush can assist you with determining if your product meets the FDA’s definition of a medical device and therefore its classification and what steps must be taken to place on the market legally. The FDA requires most medical devices to obtain clearance through a process known as Premarket Notification [510(k)]. This notification is a submission consisting of various documentation verifying substantial equivalence between your device and a similar legally marketed device.

Lloyd and Bush can assist with all aspects of preparation and review of your 510(k) submission.

Additional Services

  

These are just a few of the other services provided such as but not limited to:

  • Develop and implement Quality Management System per FDA      requirements
  • Perform internal auditing of your Quality Management System
  • Respond to an FDA Form 483 Letter and or FDA Warning Letter