FDA 510K Consultants
Qualified and experienced US FDA 510k Consultants and technical experts team in an organization assure quicker FDA 510k clearance. We can make the process faster and easier without any disappointments in terms of time and effort put.
FDA 510K Consultants with sound technical know-how.
Our team of FDA 510k Consultants has the caliber and previous history. We assure you the same again and again!
If you are a manufacturer or a specification developer, we can help you with the US FDA 510k guidance and technical consultation.
This helps our FDA 510k consultants to prepare and submit the 510(k) file quickly, with less chance of receiving an initial “Refuse to Accept” (RTA) hold or an “Additional Information” (AI) request from the FDA reviewer.
Advantages of FDA 510k Consulting Service
Following are the major activities taken care of by FDA 510k Consulting Service provider:
- Identifies the device common name, classification, regulation number and product code
- Based on the product code of the device, identifies any special controls available
- Based on the second stage, decides the type of 510K submission as Traditional, Abbreviated or Special
- Identifies the predicate device, the device description, intended use and indication for use
- Identifies the product development stage and confirm the product development, non-clinical and clinical testing, if any
- Confirms the FDA recognized consensus standards and the performance tests to be performed
- Based on the Biological evaluation standard ISO 10993-1, identifies the biocompatibility tests to be performed
- Establishes the Substantial Equivalence between predicate device and subject device considering the characteristics of the device
- Plans for the pre-submission if any specific questions exist for the 510k submission
- Arranges all biocompatibility test reports, labeling, sterilization, if applicable, shelf-life test reports, software validation reports, if applicable
- Arranges all the performance test reports, electrical safety and electromagnetic compatibility, risk management Files
- Arranges the fees sheet and financial disclosure statement
- Arranges all documents as per the Acceptance Checklist and FDA proposed order and according to the mode of submission
Types of FDA 510k Consulting Service from I3CGLOBAL
A. 510k Guidance, Preparation & US Agent Service.
- Collaborate and work with client team by guiding on required outputs for the successful submission
- Reconfirm the classification, product code and regulation number.
- Select the proper predicate for your 510k submission
- Preparation of 510k
- Act as US Agent
- Electronic & hard copy submission(s)
- Answering to review comments and File re-submission.
B. 510k Review/GAP Assessment.
- Device understanding
- Review of client prepared 510k file.
C. 510k US Agent Service
- Act as the US Agent
- Communication channel between the FDA and foreign facility
- E-copy and hard copy submissions to the FDA
FDA 510k Consultants and scheduled Timeline
While reading the FDA website, it is clear that the FDA 510k Clearance Time set by the FDA authorities is within 90 working days. The possible delay due to RTA and AI, their internal review clock stops and does not begin again until you rectify and inform the reviewer.
Our experience with the majority of medical devices’ FDA 510k clearance was obtained in 08-10 months.