5 of the more common gaps in 510(k)

documentation when converting to a technical

file and how to fix them
If you have the impression that FDA demands more than the EC to achieve
product clearance/approval, with Standard Technical Documentation
requirements, i.e., compiling a Technical File (TF), this is not the case.
Here's 5 parts of a technical file 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 comprises
"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:
a. 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";
b. 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 your device's technology is not overly novel, it may be
possible to use data showing conformity to recognized
standards.
c. 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.
d. 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 PostProduction Info systems. If data is unavailable, you may have no
escape from generating ita through a small-scale clinical trial. If
so, keep it small, focused on the questions at hand, and
statistically significant.

e. "Bring all the clinical data together" to reach conclusions about

your device's clinical safety and performance. Essentially, a
benefit-risk 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 fundamental component of the TF derives from the Annex
Is of the Medical Device Directives, or from the Proposed
Regulation, respectively. There is no such review in a 510(k).
Put together 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 Fret. If you are performing your RM activities a/p 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, put one together. Otherwise, see 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. Make sure 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 (a/p Annex VII (proposed
EU regulations) or Annex IX (MDD)) The full list above actually hinges
on this determination. 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.