Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"

[MIREGMGR]

Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

What type of questions should be asked to the R&D, Mfr Depts that will be initiating the change?

You should be starting from the decision-question-list in the FDA deciding-whether-to-submit guidance.

 

[Ronen E]

Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Please note that the FDA is currently in the process of reviewing the current practice and guidance. Probably a new guidance will be published some time in the foreseeable future.

More details: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm347888.htm

 

[drewsky1]

Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

yes, that would be best. Just wanted to get input on other SOP's that other's may be using.

Thanks

 

[cff920]

Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Lately, it appears that FDA is making efforts (or struggling with) to clarify two grey areas:
（1） Malfunction and the criteria of its reportability;
(2) Threshold that a design change to trigger 510(k) submission

Both areas are sensitive, and a firm could easily be given 483 and Warning Letter, if any violation is detected in FDA inspection.

But, despite the suffering that the industry had, FDA has the most comprehensive and informative database of device adverse events among all regulators. I personally respect FDA's achievements in this, although I dislike FDA.

 

[ss2013]

Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

I AM SEEKING A GENERAL TEMPLATE/SAMPEL OF A 510(K) LETTER TO FILE (ADD TO FILE) FOR INTERNAL FILING.

DOES ANYONE HAVE A REALLY GOOD TEMPLATE/TOC/SAMPLE?

THANK YOU!!

 

[MIREGMGR]

Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

US FDA today issued a 114-page document, "Report on FDA's Policy to be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices", available at https://www.fda.gov/downloads/Medic...ivery&utm_medium=email&utm_source=govdelivery

Summarizing, they say they're going to keep the K97-1 process, but tune it up in several ways.

Next step is a draft guidance.

 

[ss2013]

Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Does anyone have a current template for Letter to File with cover or statement?

Thanks

 

[tallu]

Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Could some one provide "table of content" for Letter to File?

Or is it something like this:
- design change input
- risk management review
- in-house v&v activities
- applicable 60601 series test reports

What needs to be included?

 

[ss2013]

Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

This is great. I truly appreciate this new information!!

ss2013

 

[Ronen E]

Re: Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File

Could some one provide "table of content" for Letter to File?

Or is it something like this:
- design change input
- risk management review
- in-house v&v activities
- applicable 60601 series test reports

What needs to be included?

Hi,

In my opinion this is way too much. All these belong in the DHF.

A letter to file should only contain a brief (yet unambiguous) description of the change, or a reference to other documents that describe it; and a thorough documented analysis showing how - by FDA standards (at the moment, it's mostly K97-1) - the change doesn't require a 510k.

It's "a letter", not "a book"

Cheers,
Ronen.