We assist in strategic planning, 510k submissions, FDA 483 & warning letters, as well as validations (including software).
Several regulatory pitfalls and major expenses can be avoided by minimal upfront investment.
Few examples of such pitfalls are:
▪ A manufacturer not periodically reviewing the regulatory status of the devices, including the exemption status from 510k
▪ An inventor not adequately defining the relationship with FDA and the contract manufacturer, including regulatory obligations.
▪ An initial importer into US market not having the controls related to complaint handling, Medical Device Reporting and Recall.
Our regulatory mock audit and report will let you define the potential pitfalls before they become costly.
FDA requires many devices to be cleared via 510k process before being legally sold in US market, as explained at this link: 510(k) Clearances.
For a 510k submission to be adequately documented and defended, the following most common situations need to be recognized and avoided:
▪ A common misconception is that contracting a consultant by itself gets a 510k cleared. For a 510k to be cleared, it has to be a team effort. You are the designer who is providing the information about your device. With your support, we can assist and complement the information to suit FDA requirements, and document the same for their review.
▪ A common delaying factor occurs when an adequate predicate device has not been identified and when a detailed technical comparison has not been conducted. Anecdotal comparisons won’t be enough.
▪ A common error is to rush in submitting the 510k to the FDA, without being adequately prepared. FDA now restricts the Q&A rounds. If the answers are not satisfactory within the limits of this restriction, the 510k will be rejected.
It is most beneficial and cost effective to use a three-step approach in a 510k submission.
The first step is to review the device and existing documentation, compare the same with FDA requirements, and conduct a gap analysis. This step is streamlined by using our secured portal located at www.510kdevicesubmissions.com.
The second step is to conduct any required laboratory tests (in addition to clinical and usability studies, where applicable), as well as update the labeling information to suit FDA regulations. The more preparations you have done already, the less it will take to complete this most demanding step.
The third step is to submit the 510k and timely respond to FDA questions (“deficiencies”).
FDA 483 is the result of FDA inspection to an establishment where deficiencies were identified. (Refer to: Inspection Observations). If not proactively and timely addressed, an FDA 483 may result in a warning letter.
Warning letter is the result of serious regulatory violations. (Refer to: 4-1 - WARNING LETTERS)
We can drop by on a short notice and work diligently to meet FDA’s time restrictions.
Whether your device is a stand-alone software or software/hardware combination, whether a 510k is required or not, appropriate validation is required, including risk analysis.
Furthermore, if a 510k is required, appropriate software documentation needs to be submit to FDA as part of the 510k.
We can assist you in producing the documentation, guiding you throughout the complete process.