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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)
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
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.

g. 3) Post-Market Clinical Follow up (PMCF) Plan (and report) – The FDA requires PMS activities only once they have requested it from the manufacturer.e. Now sum it up in a report. IIb or III of the current MDD. which are obviously not parallel to Classes A-D in the proposed Regulation. Reference this in your TF. If you are performing your RM activities a/p ISO 14971. 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. Manufacturers may not yet have formulated such a plan. respectively. Method used to demonstrate conformity –harmonized standard.. a benefit-risk analysis. FDA defines Classes I through III. There is no such review in a 510(k). Reference it in your TF. . see next item.the controlled document/s demonstrating fulfillment of the ER. if you've performed post-market surveillance. 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. Common Technical Specification (CTS). No Fret. 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. Make sure you also include in the report a confirmation that appropriate methods are in place to obtain production and post-production information. Essentially. Otherwise. "Bring all the clinical data together" to reach conclusions about your device's clinical safety and performance. A PMS Plan then needs to be submitted. nor the classes I. Involve qualified team members: e. you most likely have fulfilled this ISO 14971 requirement. or from the Proposed Regulation. you will have an RMP or separate system including a plan for observations. What about the PMCF report? Well. etc…? Specific Standard or CTS applied Evidence of conformity . put one together. assessment and action (ISO 14971:2007 § 9 and TR 24971§ 4). If detailed enough. you can reference the report as a PMCF report as well. 4) RM Report – While not required by the FDA in your 510(k) submission. IIa. experts in the medical condition and device technology.

Document in your TF. and classify your device. identify the relevant rule.Using either of the latter systems. .