5 Common Gaps in 510(k) Documentation When

Converting to a Technical File and How to Fix Them

By Avraham Harris
Principal at HARC
Here's 5 parts of a Technical File (TF) you are likely
to be missing in your 510(k) documents:
1. The biggest one first. Clinical evidence
The FDA states "clinical data is not needed for
most devices cleared by the 510(k) process".
The MDD 93/42/EEC (annex X) and proposed
MD Regulation (Annex II) require a clinical
evaluation to be performed and the evaluation
report to be part of the TF. Once formulated, the
report becomes "Clinical Evidence" of the safety
and performance of the medical device for
demonstrating conformity with the relevant
Essential Requirements (ER).
Here's how to fill this gap using 5 steps offered
by MEDDEV 2.7.1 Rev. 3:
1. Identify the ERs requiring clinical support. E.g.,
the device "shall not compromise the clinical
condition or the safety of patients, or the safety
and health of users" and "any risks which may
be associated with their use constitute
acceptable risks when weighed against the
benefits to the patient";
2. Identify and "Data Pool" existing clinical data
relevant to the device and its intended use. This
should include any available post-marketing data
on the same or similar device. But it may also
comprise data from clinical trials or clinical use
of a previous generation, or even a substantially

similar, device. Finally, if you are utilizing

standard methodologies in your device it may be
possible to use data showing conformity to
recognized standards.
3. Evaluate the data to determine if it's suitable for
establishing safety and performance of your
device. Even some generally unusable studies
may produce relevant data. It is important to
perform this evaluation systematically. You
might draw a chart listing the relevant ERs on
the left and indicating the data source
supporting or contradicting it, to the right. The
evaluation must objectively consider both
positive and negative data.
4. Generate any clinical data still needed. Consider
methods, other than a clinical trial, for
generating this missing data, e.g. "Data Pull"
existing field data of the same or similar devices
that may not yet have been 'pulled' through
your PMS / RM Post-Production Info systems. If
data is unavailable, you may have no escape
from generating it through a small-scale clinical
trial. If so, keep it small, focused on the
questions at hand, and statistically significant.
5. "Bring all the clinical data together" to reach
conclusions about your device's clinical safety
and performance. Essentially, conduct a benefitrisk analysis. Involve qualified team members:
e.g., experts in the medical condition and device
technology.
Now sum it up in a report.
2. ER or General Safety and Performance
Requirements Checklist This central

component of the TF is based on the Annex I of

the 3 Medical Device Directives, or from
the Proposed Regulation, respectively. There is
no such review in a 510(k).
Develop a checklist based on the principles in GHTF
N68:2012 containing all of the following columns for
each ER:
Applicable? y/n; Is the requirement
applicable? if not why.
Method used to demonstrate conformity
harmonized standard, Common Technical
Specification (CTS), etc?
Specific Standard or CTS applied
Evidence of conformity - the controlled
document/s demonstrating fulfillment of the ER.
3. Post-Market Clinical Follow up (PMCF) Plan
(and report) The FDA requires PMS
activities only once they have requested it from
the manufacturer. A PMS Plan then needs to be
submitted. Manufacturers may not yet have
formulated such a plan.
No worries. If you are performing your RM activities
in compliance with ISO 14971, you will have an RMP
or separate system, including a plan for
observations, assessment and action (ISO
14971:2007 9 and TR 24971 4). Reference this in
your TF. What about the PMCF report? Well, if you've
performed post-market surveillance, develop one.
Otherwise, see the next item.
4.RM Report
While not required by the FDA in your 510(k)
submission, you most likely have fulfilled this

ISO 14971 requirement. Reference it in your TF.

Ensure you also include in the report a
confirmation that appropriate methods are in
place to obtain production and post-production
information. If detailed enough, you can
reference the report as a PMCF report, as well.
5. Risk class/applicable classification
rule (based on Annex VII (proposed EU
regulations) or Annex IX (MDD)) FDA
defines Classes I through III, which are
obviously not parallel to Classes A-D in
the proposed Regulation, nor the classes I, IIa,
IIb or III of the current MDD.
Using either of the latter systems, identify the
relevant rule, and classify your device. Document in
your TF.