FDA Class I Medical Device Safety and Efficacy Data Requirements

[Sheila1]

Hi Everyone

I am wondering what sort of safety and efficacy data is needed to be documented for a Class I device. I understand that a submission is not required, but wanted to know what best practices are for documentation. It seems that safety and efficacy data should be documented, but how much? Can safety be a matter of a MSDS for the material to show biocomp?

As far as efficacy, if there's not a way to demonstrate it does what it's meant to do without involving a human subject, is one person sufficient? Is a clinical trial needed? Or can a rationale be made from the design of the device?

Thanks!

 

[Ronen E]

Hi Everyone

I am wondering what sort of safety and efficacy data is needed to be documented for a Class I device. I understand that a submission is not required, but wanted to know what best practices are for documentation. It seems that safety and efficacy data should be documented, but how much? Can safety be a matter of a MSDS for the material to show biocomp?

As far as efficacy, if there's not a way to demonstrate it does what it's meant to do without involving a human subject, is one person sufficient? Is a clinical trial needed? Or can a rationale be made from the design of the device?

Thanks!

Hi Sheila,

Generally speaking, class I devices are only subject to the FDA's General Controls. Assuming that we're discussing a class I device that's both 510(k)-exempt and not subject to the Design Control requirement under the QSR (21 CFR 820) - which you should verify first, there's no formal requirement under the regulations to document safety and/or efficacy information. Best practices say that you should gather and keep enough information to make you confident in placing the device on the market. How much is that? Depends on the nature of the device and on your taste for risk - not necessarily regulatory or medical risk but mostly business risk. In exempting manufacturers of most class I devices from formal requirements to maintain such information, the FDA had implicitly stated that it considers the associated risk of not doing so as very low and that it is not concerned with how manufacturers choose to act in that regard.

Whether or not any MSDS or biocompatibility information would be appropriate as safety evidence depends, again, on the nature of the device. It could be anything from appropriate and sufficient to irrelevant.

Clinical trials are not likely to be required for class I devices, however, where a clinical trial is required it definitely requires a sample size >1. It's quite likely that a design rationale would suffice, and it would make good business sense to have it on record, but from a regulatory perspective even that is not required where Design Control is N/A to the specific device code.

Cheers,
Ronen.

 

[Sheila1]

That makes sense. Thank you!

 

[Sheila1]

Sorry, one more question. I checked and the regulation does not exempt the device from QSR so I assume you need a little more documentation. Also, how do you know if a clinical trial is needed?

Thanks!

 

[Ronen E]

Sorry, one more question. I checked and the regulation does not exempt the device from QSR so I assume you need a little more documentation. Also, how do you know if a clinical trial is needed?

Thanks!

From 21 CFR 820.30 (Design Control):

(2) The following class I devices are subject to design controls:

(i) Devices automated with computer software; and

(ii) The devices listed in the following chart.

Section Device
868.6810 Catheter, Tracheobronchial Suction.
878.4460 Glove, Surgeon's.
880.6760 Restraint, Protective.
892.5650 System, Applicator, Radionuclide, Manual.
892.5740 Source, Radionuclide Teletherapy.

If your device is not in any of the above categories, it's exempt from Design Control and thus the requirements for documentation relating to its design (eg information supporting safety and efficacy) range from nil to minimal.

I can't think of a scenario where a clinical trial would be required for a class I, 510(k) exempt device. Even class II non-exempt devices don't always require clinical data submission.

 

[Sheila1]

Thank you!