I have a question regarding obsoleting a medical device product.

When we obsolete products, we have to keep documents and records for at least the life time of the last products manufactured. What about other parts or components? Is there any regulation asking us to keep components or raw materials until the life time of the product, in case it comes back for repairs?

Thanks for your inputs.

Amjadrana

They are all part of the records of the device so those records must be maintained.

I have a question regarding obsoleting a medical device product.

When we obsolete products, we have to keep documents and records for at least the life time of the last products manufactured. What about other parts or components? Is there any regulation asking us to keep components or raw materials until the life time of the product, in case it comes back for repairs?

Thanks for your inputs.

AmjadranaI guess whether you keep a supply of repair parts for obsolete equipment depends upon the reason it was obsolete as well as the nature of the product.

I think I'd want a new pacemaker instead of trying to fix an old, obsolete one. Is it more cost effective to replace an obsolete device with a new one instead of trying to repair the obsolete one?

Will you charge for repairs or will they be under guarantee or warranty?

Do your guarantees and warranties allow you to substitute devices if the original is broken beyond repair?

If I have a giant MRI that is only obsolete because the company brought out a new model in white instead of putty color, I think I'd want repair parts if I had to pay for replacement of an entire MRI.

If there are a million devices in use, you have a different situation than if 1 thousand are in use.

Was part of the original contract of sale guaranteed repairs for the life of the product or of the patient?

How difficult would it be to have replacement parts made from part drawings? How long a lead time?

These and dozens of other questions must be answered before determining the need to maintain a pool of repair parts.

In any regard, the RECORDS of the components, including part drawings and instructions, must be retained even if you do not retain the parts and components themselves.

I have a question regarding obsoleting a medical device product.

When we obsolete products, we have to keep documents and records for at least the life time of the last products manufactured. What about other parts or components? Is there any regulation asking us to keep components or raw materials until the life time of the product, in case it comes back for repairs?

Thanks for your inputs.

Amjadrana

I had to check on this one myself. No there are no FDA regulations requiring you to maintain the subcomponents/raw materials to repair the device.

Thank you all for the inputs. It was really informative. Wes inputs were great, whether these are medical devices or not.

Thanks again.

Amjad Rana

If any events happened in the field (i.e. complaint per 820.198) after your products become obsolete AND such events are subject to 803 MDR and/or 806 Corrections and Removals, your company is still responsible to have necessary resources (e.g. R&D for re-design, MFG/procurement on replacement parts, etc).