We assist in strategic planning, 510k
submissions, FDA 483 & warning letters, as well as validations
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
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
FDA requires many devices to be cleared
via 510k process before being legally sold in US market, as
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
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
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
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.