FDA and Medical Device Exemptions from GMP Requirements

Q

QACen

#1
Hello Fellow Quality Gurus,

First, please don't shoot me if I didn't read all of the threads that exists about this topic. If I missed it, I'm sorry. Just asking for help and direction.

I want to make sure that I understand this correctly of the following statement. One of our devices is a Class 1 product with exemptions:
"FDA has determined that certain types of medical devices are exempt from GMP requirements. These devices are exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180).

So does this mean that its ok to avoid doing the design control process because of this statement? Are there any of you that do this in the company? Do you not document the development of new products at all if you have somehow already determined it is a class I device? I'm in a company where they are looking at all together to save time in the development process and avoid doing the thing that takes a while to do --- document and develop sound verification/validation, and laborious testing. I'm all for streamlining. But I have to ask - does that work? In the end how else do you capture decisions and thoughts throughout the process as well as intellectual property?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

GMP exempt is not the same as Design Control exempt. If you go to the relevant FDA ProCode webpage, you will see whether or not that ProCode is GMP exempt.

Regardless, most class 1 devices are Design Control exempt (see 820.30 for those that aren't). Yes, if your class 1 device is Design Control exempt, it means that you don't have to implement it - as far as FDA is concerned. However, you'd still need a DMR, which means your released design has to be somehow captured.

Regulation aside, I agree that lacking accessible design history documentation can cause trouble, and it's generally better practice to keep it nevertheless. On the other hand, if an "extra-lean" business culture prevails, this can be seen as extra burden.

Cheers,
Ronen.
 
M

MIREGMGR

#3
So does this mean that its ok to avoid doing the design control process because of this statement? Are there any of you that do this in the company?
The company for which I work develops and markets a mix of devices within the US-FDA-Class I-and II-EU-MDD-Class-I regulatory range, some of which per FDA are design control exempt, some of which are GMP exempt. We strategically considered your question a number of years ago, and decided to design-control-comply and GMP-comply for all device products, for two general reasons:

1. We market many devices globally. Other major device regulators than US FDA have different, or in some cases no, distinctions between device classifications as to regulatory requirements. The simplest way to assure that a given project is globally compliant is to fully design control and GMP-comply.

2. Occasionally FDA changes their regulatory stance on a device class. Occasionally FDA wants to deep-dive into a device design history as a result of an adverse event. Occasionally a Class I device becomes an antecedent of a Class II device for which a 510(k) is required, and so design controls form a key part of the predicate design history. We want to assure that we are systematically prepared to defend the design of all of our products, whatever the circumstance.
 
Q

QACen

#4
Thank you Ronen E and MIREGMGR for your feedback. You both made pretty good points.

MIREGMGR - Thank you for sharing your experience. We are looking into the EU market next year so your point about the global compliance makes sense. Being ISO certified, we are obligated to establish a design control process anyway. I would find it more cumbersome to audit and keep track of different processes that apply to a particular product.

Very, very helpful. Thank you again!
 
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