Regulatory Open Forum

Can anyone provide any guidance on Class I medical devices requiring design controls. 

This link says the following:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30

(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.

What kind of devices fit into category (i)? This is not any device encompassing software, correct?

Any recommendations on minimal requirements for design controls for any Class I devices (across different jurisdictions) would be great. I'm curious to know what level of design controls, if any at all, other companies are applying to Class I devices.

Thank you.

I'm not exactly sure what kind of guidance you're looking for, but two ways I can suggest to determine whether design controls are required for a class I device is to:

1. find the product code of the device in question and see if it's GMP exempt.

2. brute force approach. download the product classification files from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051668.htm. Look for the 'foiclass.zip' file. Once you download the file (import to Excel), sort by 'DEVICECLASS' and then see which ones have the 'GMPEXEMPTFLAG' set to N.

I don't know of any Class I devices with software that would be excluded from Design Controls.

There are no "minimal requirements" for different device classes; all elements of Design Control are required. The scope of the activities may be different, however.

Can anyone provide any guidance on Class I medical devices requiring design controls. 

This link says the following:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30

(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.

What kind of devices fit into category (i)? This is not any device encompassing software, correct?

Any recommendations on minimal requirements for design controls for any Class I devices (across different jurisdictions) would be great. I'm curious to know what level of design controls, if any at all, other companies are applying to Class I devices.

Thank you.

Michael, does the word "automated" add anything to this guidance?  Are there devices "with" software that are not "automated with" software?

I'm not exactly sure what kind of guidance you're looking for, but two ways I can suggest to determine whether design controls are required for a class I device is to:

1. find the product code of the device in question and see if it's GMP exempt.

2. brute force approach. download the product classification files from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051668.htm. Look for the 'foiclass.zip' file. Once you download the file (import to Excel), sort by 'DEVICECLASS' and then see which ones have the 'GMPEXEMPTFLAG' set to N.

I don't know of any Class I devices with software that would be excluded from Design Controls.

There are no "minimal requirements" for different device classes; all elements of Design Control are required. The scope of the activities may be different, however.

Can anyone provide any guidance on Class I medical devices requiring design controls. 

This link says the following:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30

(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.

What kind of devices fit into category (i)? This is not any device encompassing software, correct?

Any recommendations on minimal requirements for design controls for any Class I devices (across different jurisdictions) would be great. I'm curious to know what level of design controls, if any at all, other companies are applying to Class I devices.

Thank you.

Can anyone provide any guidance on Class I medical devices requiring design controls. 

This link says the following:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30

(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.

What kind of devices fit into category (i)? This is not any device encompassing software, correct?

Any recommendations on minimal requirements for design controls for any Class I devices (across different jurisdictions) would be great. I'm curious to know what level of design controls, if any at all, other companies are applying to Class I devices.

Thank you.

Can anyone provide any guidance on Class I medical devices requiring design controls. 

This link says the following:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30

(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.

What kind of devices fit into category (i)? This is not any device encompassing software, correct?

Any recommendations on minimal requirements for design controls for any Class I devices (across different jurisdictions) would be great. I'm curious to know what level of design controls, if any at all, other companies are applying to Class I devices.

Thank you.

In the US, design controls apply to Class III, Class II, any device with software, and any device on the list in 820.30(2)(ii). If your finished device contains software, then you must apply design control.

If the finished device has software, then it is subject to design controls. FDA QSR has the minimal requirements for design control. If design control applies, then you must establish (define, document, and implement) and maintain procedures for each sub-section of 820.30. The manufacturer determines the content, as long as they meet the minimum requirements. In 820.30(g), you can exclude software validation as not applicable if the finished device does not contain software.

For completeness sake, there are other requirements for software used in the QMS or software used in production. These apply regardless of device class.

Can anyone provide any guidance on Class I medical devices requiring design controls. 

This link says the following:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30

(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.

What kind of devices fit into category (i)? This is not any device encompassing software, correct?

Any recommendations on minimal requirements for design controls for any Class I devices (across different jurisdictions) would be great. I'm curious to know what level of design controls, if any at all, other companies are applying to Class I devices.

Thank you.

And then there is mobile app enforcement discretion, where design controls are strongly recommended...

In the US, design controls apply to Class III, Class II, any device with software, and any device on the list in 820.30(2)(ii). If your finished device contains software, then you must apply design control.

If the finished device has software, then it is subject to design controls. FDA QSR has the minimal requirements for design control. If design control applies, then you must establish (define, document, and implement) and maintain procedures for each sub-section of 820.30. The manufacturer determines the content, as long as they meet the minimum requirements. In 820.30(g), you can exclude software validation as not applicable if the finished device does not contain software.

For completeness sake, there are other requirements for software used in the QMS or software used in production. These apply regardless of device class.

Can anyone provide any guidance on Class I medical devices requiring design controls. 

This link says the following:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30

(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.

What kind of devices fit into category (i)? This is not any device encompassing software, correct?

Any recommendations on minimal requirements for design controls for any Class I devices (across different jurisdictions) would be great. I'm curious to know what level of design controls, if any at all, other companies are applying to Class I devices.

Thank you.

And then there is mobile app enforcement discretion, where design controls are strongly recommended...

Can anyone provide any guidance on Class I medical devices requiring design controls. 

This link says the following:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30

(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.

What kind of devices fit into category (i)? This is not any device encompassing software, correct?

Any recommendations on minimal requirements for design controls for any Class I devices (across different jurisdictions) would be great. I'm curious to know what level of design controls, if any at all, other companies are applying to Class I devices.

Thank you.

If you are responsible for regulatory compliance, then of course this matters.  Otherwise, it doesn't. 

Design controls weren't invented by FDA, but by product developers.  In my experience, software developers were following design controls long before CDRH ever heard of them.  If a company is trying to develop a software product (standalone or otherwise) without following design controls, any regulatory requirements are the least of its worries. IMO.

Can anyone provide any guidance on Class I medical devices requiring design controls. 

This link says the following:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30

(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.

What kind of devices fit into category (i)? This is not any device encompassing software, correct?

Any recommendations on minimal requirements for design controls for any Class I devices (across different jurisdictions) would be great. I'm curious to know what level of design controls, if any at all, other companies are applying to Class I devices.

Thank you.

Hmmm, my experience has been more that some software developers were following some design controls.prior to the QSR. I have, however, over the years, seen many, many gaps in software design controls. Among the most common

- using incomplete or poorly written requirements

- using direct VoC as requirements rather than translating them

- thinking that DVal can happen "after beta launch"

- little to no thought put into design transfer "what do you mean the service guys can't install it?"

- not keeping trace matrix "history" or good design history - often in Agile software programs where it is deemed to be "busywork"

At one point I even had a software developer tell me "FDA doesn't require software validation" so there is quite the mix out there.

g-

If you are responsible for regulatory compliance, then of course this matters.  Otherwise, it doesn't. 

Design controls weren't invented by FDA, but by product developers.  In my experience, software developers were following design controls long before CDRH ever heard of them.  If a company is trying to develop a software product (standalone or otherwise) without following design controls, any regulatory requirements are the least of its worries. IMO.

Can anyone provide any guidance on Class I medical devices requiring design controls. 

This link says the following:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30

(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.

What kind of devices fit into category (i)? This is not any device encompassing software, correct?

Any recommendations on minimal requirements for design controls for any Class I devices (across different jurisdictions) would be great. I'm curious to know what level of design controls, if any at all, other companies are applying to Class I devices.

Thank you.

Hmmm, my experience has been more that some software developers were following some design controls.prior to the QSR. I have, however, over the years, seen many, many gaps in software design controls. Among the most common

- using incomplete or poorly written requirements

- using direct VoC as requirements rather than translating them

- thinking that DVal can happen "after beta launch"

- little to no thought put into design transfer "what do you mean the service guys can't install it?"

- not keeping trace matrix "history" or good design history - often in Agile software programs where it is deemed to be "busywork"

At one point I even had a software developer tell me "FDA doesn't require software validation" so there is quite the mix out there.

g-

Hmmm, my experience has been more that some software developers were following some design controls.prior to the QSR. I have, however, over the years, seen many, many gaps in software design controls. Among the most common

- using incomplete or poorly written requirements

- using direct VoC as requirements rather than translating them

- thinking that DVal can happen "after beta launch"

- little to no thought put into design transfer "what do you mean the service guys can't install it?"

- not keeping trace matrix "history" or good design history - often in Agile software programs where it is deemed to be "busywork"

At one point I even had a software developer tell me "FDA doesn't require software validation" so there is quite the mix out there.

g-

If you are responsible for regulatory compliance, then of course this matters.  Otherwise, it doesn't. 

Design controls weren't invented by FDA, but by product developers.  In my experience, software developers were following design controls long before CDRH ever heard of them.  If a company is trying to develop a software product (standalone or otherwise) without following design controls, any regulatory requirements are the least of its worries. IMO.

Can anyone provide any guidance on Class I medical devices requiring design controls. 

This link says the following:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30

(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.

What kind of devices fit into category (i)? This is not any device encompassing software, correct?

Any recommendations on minimal requirements for design controls for any Class I devices (across different jurisdictions) would be great. I'm curious to know what level of design controls, if any at all, other companies are applying to Class I devices.

Thank you.