Hi there,
My company recently went through a similar exercise, and I'd be happy to share what we've learned. We're a drug manufacturer that's manufacturing our first IVD for Covid-19 testing, so design control requirements were unfamiliar to us too. For our IVD, design controls are not required because it's a Class I device that does not have a specific requirement for design controls.
I think the first thing you should look at is the classification of your device (Class I, II, or III). 21 CFR 820.30 states that all Class II and Class III devices and only certain Class I devices are subject to design controls (see below). If your IVD is a Class I device that isn't specifically listed in 21 CFR 820.30 (a)(2), design controls are not required.
| Sec. 820.30 Design controls. |
|
(a) General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
(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. |
|
I hope that helps!
------------------------------
Jane Griffin
Sr. Supervisor, Compliance
San Diego CA
United States
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Original Message:
Sent: 01-Jun-2020 15:23
From: Anonymous Member
Subject: Does IVD EUA require Design Control 820.30?
This message was posted by a user wishing to remain anonymous
Hello,
I have read several of the FDAs guidance on the EUA authority and process, but I need help finding an answer.
Does an IVD that is developed and submitted (or intended to be submitted) require compliance to 21 CFR part 820, specifically Design Control 820.30? I found that FDA has the authority to waive the requirement, but no evidence that they have actually waived the requirement. I see that for ventilators they have waived it, but I am in IVDs. Can someone point me to the correct guidance or publication that addresses this question?