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
