Medical Devices

510k – Premarket Notification – US FDA Consultants India

510k – Premarket Notification – US FDA Consultants India

Perfect Pharmaceutical Consultants is a regulatory consultant helping Medical device Manufacturers market their product in US FDA and other countries.

Steps to Market your Product in United States
  • To Make Sure the product you look to market fits in definition of Medical Device as US FDA and be absolutely sure about the same.
  • Classify your product as per Classification guidelines of US FDA. Normally your device will fall into Class 1 or Class 2 or Class 3 unless exempt.
  • Development of Data / Master Files for required application as per classification.

510k – Premarket Notification – US FDA

A 510k application needs to be filled for Class 1, II, & III devices intended for human use , must submit an 510K application, unless the device is exempted from 510k or Pre market approval and dose note exceed the limitation of exemptions. PPC as a medical device consultant can help your classify your device and accordingly guide with the required route or procedure to get your product cleared for sale in US.

Perfect Pharmaceutical Consultants works as root level and can help you from scratch to end in development and filling a 510k Application and helping your begin your exports in US.

PPC provides following services In regard to a Medical Device 510k Application
  • Development of Application & submission File
    • Product Assessment & identifying of Predicate
    • Designing test requirements of the Products
    • Identifying list of documents required to complete the Master file & helping customers develop the missing documents or from scratch.
    • Writing the Master file
    • Establishing Labeling requirement as per US FDA
    • Designing the Claim and broucher with the help of the client
  • Submission & Review of 510K
    • Verification of 510K Submission file
    • Identifying additional information need for the submission
    • Completing the file and making application for 510K
    • Coordinating fees with US FDA for application
  • Post Submission & Query Handling
    • PPC helps with Post submission query handling for your submission made
    • Getting Final clearance for sale of medical device
    • Training your personnel for US FDA requirements , Audits
    • Implementing GMP & Quality System in your Plant as per US FDA requirements
Do you need to file a 510K Application??? Know now – “”Without Any obligation””