Regulatory Open Forum

This question came up today during MR.

Company designs and Manufacturers a Class II Medical Device 

FDA Visits and audits the company and device design/productions etc.

Company adds a new separate FDA Cleared medical device to its inventory.

FDA Visits and audits 1) Just the new device 2)Both devices 3) whatever is in its QMS or 4) It depends on reason for audit

What if its not for cause?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Hello Ed,

If the FDA in conducting a routine inspection (currently commonly known as a QSIT inspection) they would review 1, 2 and 3.  There is no "set agenda" for a routine inspection which would start with the quality system, review aspects of the products, and would meander to wherever the inspector needs to confirm compliance.  Of course, you probably know it loosely follows the QSIT Guide which was published years ago.  If the inspection is "for cause" then definitely 4.  You can always ask the inspectors when they show up, and sometimes they divulge, e.g. follow-on from a recall, or sometimes they will not, e.g. device safety concern raised.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE

Original Message:
Sent: 21-Nov-2023 14:35
From: Ed Panek
Subject: FDA Product Audits

This question came up today during MR.

Company designs and Manufacturers a Class II Medical Device 

FDA Visits and audits the company and device design/productions etc.

Company adds a new separate FDA Cleared medical device to its inventory.

FDA Visits and audits 1) Just the new device 2)Both devices 3) whatever is in its QMS or 4) It depends on reason for audit

What if its not for cause?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Thanks all for the feedback. If the company wanted to design and produce a third non medical device but utilize its current QMS that has 2 FDA regulated products within it, is that an issue? Can an FDA compliant QMS serve as the structure for non medical devices in the same company?

Hello Ed,

If the FDA in conducting a routine inspection (currently commonly known as a QSIT inspection) they would review 1, 2 and 3.  There is no "set agenda" for a routine inspection which would start with the quality system, review aspects of the products, and would meander to wherever the inspector needs to confirm compliance.  Of course, you probably know it loosely follows the QSIT Guide which was published years ago.  If the inspection is "for cause" then definitely 4.  You can always ask the inspectors when they show up, and sometimes they divulge, e.g. follow-on from a recall, or sometimes they will not, e.g. device safety concern raised.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE

Original Message:
Sent: 21-Nov-2023 14:35
From: Ed Panek
Subject: FDA Product Audits

This question came up today during MR.

Company designs and Manufacturers a Class II Medical Device 

FDA Visits and audits the company and device design/productions etc.

Company adds a new separate FDA Cleared medical device to its inventory.

FDA Visits and audits 1) Just the new device 2)Both devices 3) whatever is in its QMS or 4) It depends on reason for audit

What if its not for cause?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Yes, I have a client that does that. They make intercom systems. Some are Nurse Call Stations in hospitals, some are used in parking garages, some for high rise apartment buildings, etc.<o:p></o:p>

<o:p> </o:p>

I wrote the QMS procedures for the FDA regulated Nurse Call Stations. The scope says something like, "This procedure applies to medical device products, but <company> may use the methods for other products." Some parts of the system are common to all products such as control and disposition of nonconforming product. The MRP system has a field to distinguish been medical and non-medical products, so they can limit the scope during an FDA Investigation.<o:p></o:p>

Thanks all for the feedback. If the company wanted to design and produce a third non medical device but utilize its current QMS that has 2 FDA regulated products within it, is that an issue? Can an FDA compliant QMS serve as the structure for non medical devices in the same company?

Hello Ed,

If the FDA in conducting a routine inspection (currently commonly known as a QSIT inspection) they would review 1, 2 and 3.  There is no "set agenda" for a routine inspection which would start with the quality system, review aspects of the products, and would meander to wherever the inspector needs to confirm compliance.  Of course, you probably know it loosely follows the QSIT Guide which was published years ago.  If the inspection is "for cause" then definitely 4.  You can always ask the inspectors when they show up, and sometimes they divulge, e.g. follow-on from a recall, or sometimes they will not, e.g. device safety concern raised.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE

Original Message:
Sent: 21-Nov-2023 14:35
From: Ed Panek
Subject: FDA Product Audits

This question came up today during MR.

Company designs and Manufacturers a Class II Medical Device 

FDA Visits and audits the company and device design/productions etc.

Company adds a new separate FDA Cleared medical device to its inventory.

FDA Visits and audits 1) Just the new device 2)Both devices 3) whatever is in its QMS or 4) It depends on reason for audit

What if its not for cause?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

This question came up today during MR.

Company designs and Manufacturers a Class II Medical Device 

FDA Visits and audits the company and device design/productions etc.

Company adds a new separate FDA Cleared medical device to its inventory.

FDA Visits and audits 1) Just the new device 2)Both devices 3) whatever is in its QMS or 4) It depends on reason for audit

What if its not for cause?

First a word about terminology. FDA sends Investigators to conduct Inspections. Some Investigators can get quite testy if you call them auditors. Keep in mind that FDA is the largest law enforcement agency in the US; the Investigators are conducting a legal investigation of your compliance with the FD&CA.<o:p></o:p>

<o:p> </o:p>

In this scenario, not a pre-approval or for cause Inspection, the Investigators are conducting a routine Inspection of your QMS. There are, or at least used to be, different types of routine Inspections based on the number of QSIT modules covered.<o:p></o:p>

<o:p> </o:p>

For QSIT design control, the first Inspectional Objectives is "Select a single design project". The Investigator will have reviewed the documentation of the prior Investigation and is likely to select the new device. However, if there were issues in the prior Investigation, even if they didn't appear on a 483, the Investigator may select the prior device to check closure.<o:p></o:p>

<o:p> </o:p>

The point is that you can't know with certainty.<o:p></o:p>

<o:p> </o:p>

The best strategy is to be Inspection ready at all times. Do this using robust procedures, good internal auditing, and reading Warning Letters. If a Warning Letter situation could happen in your company, check that it doesn't happen.<o:p></o:p>

This question came up today during MR.

Company designs and Manufacturers a Class II Medical Device 

FDA Visits and audits the company and device design/productions etc.

Company adds a new separate FDA Cleared medical device to its inventory.

FDA Visits and audits 1) Just the new device 2)Both devices 3) whatever is in its QMS or 4) It depends on reason for audit

What if its not for cause?

Hi Ed

Yes, it's possible to have a quality management system that applies to medical devices and other products. You just have to build in some decision trees around the classification for each product in each jurisdiction, for example knowing if malfunctions and adverse events would fall under the device reporting rules.

If it's documented clearly, an FDA inspector can focus on the medical device risks and largely ignore whatever else you're manufacturing.

For most employees outside the regulatory and quality teams, it's probably easier to have a single set of procedures to follow. And the company probably cares about the quality of everything it produces, regardless of whatever regulatory agency rules may or may not be applicable.

First a word about terminology. FDA sends Investigators to conduct Inspections. Some Investigators can get quite testy if you call them auditors. Keep in mind that FDA is the largest law enforcement agency in the US; the Investigators are conducting a legal investigation of your compliance with the FD&CA.<o:p></o:p>

<o:p> </o:p>

In this scenario, not a pre-approval or for cause Inspection, the Investigators are conducting a routine Inspection of your QMS. There are, or at least used to be, different types of routine Inspections based on the number of QSIT modules covered.<o:p></o:p>

<o:p> </o:p>

For QSIT design control, the first Inspectional Objectives is "Select a single design project". The Investigator will have reviewed the documentation of the prior Investigation and is likely to select the new device. However, if there were issues in the prior Investigation, even if they didn't appear on a 483, the Investigator may select the prior device to check closure.<o:p></o:p>

<o:p> </o:p>

The point is that you can't know with certainty.<o:p></o:p>

<o:p> </o:p>

The best strategy is to be Inspection ready at all times. Do this using robust procedures, good internal auditing, and reading Warning Letters. If a Warning Letter situation could happen in your company, check that it doesn't happen.<o:p></o:p>

This question came up today during MR.

Company designs and Manufacturers a Class II Medical Device 

FDA Visits and audits the company and device design/productions etc.

Company adds a new separate FDA Cleared medical device to its inventory.

FDA Visits and audits 1) Just the new device 2)Both devices 3) whatever is in its QMS or 4) It depends on reason for audit

What if its not for cause?