Regulatory Open Forum

 View Only

  • 1.  Design Control for Class I GMP exempt (with software)

    Posted 14-Dec-2020 20:15
    Edited by Reyhan MUTLU 14-Dec-2020 21:08
    Hi,

    I would like to ask if a device is classified as Class I, 510(k) and GMP exempt but has software to operate. Is this device still subjected to design control?

    According to Sec. 820.30 Design controls:

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

    (i) Devices automated with computer software

    What exactly automated means here? If the device needs an operator to fully run the device, is that still counted as 'automated'?

    Thank you!



    ------------------------------
    Reyhan MUTLU
    San Jose CA
    United States
    ------------------------------


  • 2.  RE: Design Control for Class I GMP exempt (with software)

    Posted 15-Dec-2020 05:03
    Hello Reyhan,

    In the United States, Class I devices (whether 510(k) or GMP Exempt or not) do not require design controls.  Often these are low complexity devices which have been used for many years so even if there is software, there is no requirement to have design controls in place.  Now with that said, the first you should review if software is being incorporated or added to a Class I device if this goes beyond the limits of exemption for the device type.  The second aspect should consider is if not doing design controls, would this be sufficient for other markets because the classification may not be the same in other regions.  The third aspect should think about is even though you do not have to complete design controls, would it still be a good business practices particularly to protect IP and ensure good quality products through an established design control process.  If design controls are not applied for your device, make sure you have clearly justified this in say your quality manual or technical documentation of the product.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: Design Control for Class I GMP exempt (with software)

    Posted 15-Dec-2020 13:08
    Thank for the reply Richard.

    We have Design Control SOP, risk analysis etc., bench tests are partially completed, software testing is getting automated. But, as you know it takes time to complete all those efforts.

    I am aware other markets may classify it higher. So, we are getting ready for it.

    I got confused if we sell before all design control activities are completed, we will not be in compliance (even though we are GMP exempt) since 21CFR820.30 has that section for Class I devices including automated software. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=820.30

    We have submitted 513 (g), and FDA's letter doesn't mention design controls.

    Maybe I am overthinking, I wanted to check with the community.

    Thanks again!

    Best,

    ------------------------------
    Reyhan MUTLU
    San Jose CA
    United States
    ------------------------------

    Original Message


  • 4.  RE: Design Control for Class I GMP exempt (with software)

    Posted 15-Dec-2020 13:32
    Edited by Kevin Randall 15-Dec-2020 13:35
    If an FDA class I device is, by regulation, exempt from GMP, then it is exempt from all of the GMP, including design controls, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.  A GMP exemption in a device's corresponding classification regulation presides over the requirements in the FDA's Quality System Regulation codified at 21 Part CFR 820.  The Quality System Regulation requirements do not apply (except 820.180 and 820.198) unless a device's classification regulation first requires GMP.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Ridgway, CO
    United States
    www.complianceacuity.com
    © Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 5.  RE: Design Control for Class I GMP exempt (with software)

    Posted 15-Dec-2020 13:42

    But if an FDA class 1 device is not GMP-exempt, then design controls are in fact required for the class 1 device if it is of a type listed at 21 CFR 820.30(a)(2).



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Ridgway, CO
    United States
    www.complianceacuity.com
    © Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 6.  RE: Design Control for Class I GMP exempt (with software)

    Posted 15-Dec-2020 13:59
    Thanks Kevin!

    This is very helpful. It is much more clear now.

    Happy Holidays!

    ------------------------------
    Reyhan MUTLU
    San Jose CA
    United States
    ------------------------------

    Original Message


  • 7.  RE: Design Control for Class I GMP exempt (with software)

    Posted 19-Dec-2020 10:07

    Sorting out these requirements can be a little confusing.

    First, assume the device IS NOT GMP exempt.

    Design controls apply in the following cases:

    Any Class III device

    Any Class II device

    Any Class I device with software

    Any Class I device in the table in 820.30(a)

     Notice that the conformity assessment path does not enter into the decision. For example, a Class II device that is 510(k) is subject to design control.

    Remember that QSR comes from the 1990s and some of the vocabulary has changed. Back them we automated things but putting in software.

    Second, assume the device IS GMP exempt. Then, it is exempt from design controls.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


Related Content