US FDA 510(k) Medical Device Advisory
With our US FDA 510(k) Consulting service, we help you go through the entire process by thoroughly understanding the device and identifying potential problems for any medical device Class I, Class II, and Class III. Your qualified and experienced technical expert guarantees faster 510k clearance.
If you’re a manufacturer or specification developer, please read below to understand how we support a request for an “Additional Information” (AI) from the FDA to help customers prepare and ship the 510k File faster and less likely to receive an initial “Refuse to Accept” (RTA) hold.
Our US FDA 510(k) Consulting Activities
US FDA 510(k) Documents include, but are not limited to;
- Defining Device Class, product code and Regulation
- Proper device identification, verification
- Identifying appropriate guidance and control documents
- Choosing the appropriate type* of US FDA 510(k) submission
- Preparing Indication for Statement of Use
- Declaration of conformity
- Defining biocompatibility tests
- Determination of performance test
- Sampling Plan
- Requirements for stability studies
- Review of the risk management file
- Sterilization requirements and appropriate documentation
- Labeling requirements and label review
- US FDA 510(k) summary and validation
- Identification of any clinical data/test requirements
- Device specific documentation requirements – (Software, EMC and Electrical safety etc.)
- Review of Final 510(k) File
- Pre-application (Q-submission)
- Refuse to Accept Policy for 510(k) acceptance review
- E-copy Submission
- Interacting with the FDA – Responding to Review, Comments and Additional Information requirements during the post-submission phase
- Device Listing and Registration
- US Representative Services
Benefits of appointing a Consultant for the US FDA 510(k)
- Confirm that the medical device requires US FDA 510(k) and is regulated by the FDA.
- Determine the most accurate 510(k) path to obtaining permission.
- Important Choosing an appropriate validation tool to establish equivalence.
- Prepare regulatory documents according to FDA requirements
- Well organized documentation
- Reviewing US FDA 510(k) documents and identifying compliance gaps
- Latest trends and current regulatory knowledge in requirements for application
- Helps identify requirements for appropriate performance tests, consensus standards, and other clinical/non-clinical studies.
- The US FDA510(k) consultant can provide guidance and clear recommendations on every step in documentation and testing on the medical device.
It can ensure that the file is delivered on time. - Interacting with the FDA – Reviewing, Responding to Comments, and if there is a need for Additional Information at the post-submission stage can help.
- Supports up to US FDA 510(k) clearance.
