Regulatory Open Forum

Lena,

I had planned to concur with Richard in his appraisal of the comparison of 21 CFR 820.181, Device Master Record, and ISO 13485 Section 4.2.3, Medical Device File. However, my reasoning is not the same as Richard's and is more closely related to your question to Richard.

A few disclaimers.
I have not read the AAMI document, so I'm relying on Richard's characterization of "No significant difference".

I have not discussed my opinion with Richard. My opinions are mine.

FDA's project is, in my opinion, ill-conceived and looks to me like a solution looking for a problem. I have heard three things that bear on my opinion.

Without the support of an FDA Commissioner, the project will not move forward (there is an acting Commissioner now).

FDA had planned to release the first elements of this project in April or May of 2019, but has not. This suggests to me that the project is on hold.

ISO intends to revise 13485 before FDA could complete its work.

The phrase "No significant difference" doesn't add any value because many audit nonconformances live in the gap between significant differences and actual requirements. For me, if one document has a requirement that is not in the other, then the difference is significant, and would result in an audit nonconformance.

I prefer the approach in CEN/TR 17223:2018 which maps the requirements of the EU-MDR/IVDR Article 10 to the corresponding elements of ISO 13485:2016. The attributes are "fully covered", "partially covered", or "not covered". With partially covered, there is an explanation of the gap.

If I were to map 21 CFR 820.181 to ISO 13485:2016 Section 4.2.3 my conclusion is:
Partially Covered – ISO 13485:2016 doesn't require document control, quality assurance procedures, labeling specifications, or procedures for maintenance.

Specifically –
820.182 requires "each DMR is prepared and approved in accordance with 820.40". 4.2.3 does not have a document control requirement.

820.181(a) requires device specification while 4.2.3(b) says, "specifications for the product". I consider these to be the same.

820.181(b) requires production process specifications while 4.2.3(c) says, "specifications or procedures for manufacturing, packaging, storage, handling and distribution". I consider these to be the same.

820.181(c) requires quality assurance procedures and specifications while 4.2.3 doesn't.

820.181(d) requires labeling specifications while 4.2.3(a) requires a general description of the labeling, not the labeling specifications.

820.181(e) requires maintenance procedures and methods while 4.2.3 does not.

One could map the requirements from ISO 13485:2016, 4.2.3 to 820.181 and create a similar list of differences.

The issue for me, is that there are significant differences and they should result in audit nonconformances if a manufacturer asserted that ISO 13485:2016, 4.2.3 is the same as (or without significant differences from) 820.181. (Hint: I would expect an FDA Investigator to issue a 483.)

While not asked, I'll also comment on EN ISO 13485:2016/AC2018. In particular, ISO 13485:2016, clause 4.2.3 does not satisfy EN ISO 13485:2016/AC2018, clause 4.2.3 when applied to the MDD Annex II.

The point here is most medical device manufacturers implement MDD Annex II so there are two "two hops" from QSR to the MDD QMS.

Lena,

I had planned to concur with Richard in his appraisal of the comparison of 21 CFR 820.181, Device Master Record, and ISO 13485 Section 4.2.3, Medical Device File. However, my reasoning is not the same as Richard's and is more closely related to your question to Richard.

A few disclaimers.
I have not read the AAMI document, so I'm relying on Richard's characterization of "No significant difference".

I have not discussed my opinion with Richard. My opinions are mine.

FDA's project is, in my opinion, ill-conceived and looks to me like a solution looking for a problem. I have heard three things that bear on my opinion.

Without the support of an FDA Commissioner, the project will not move forward (there is an acting Commissioner now).

FDA had planned to release the first elements of this project in April or May of 2019, but has not. This suggests to me that the project is on hold.

ISO intends to revise 13485 before FDA could complete its work.

The phrase "No significant difference" doesn't add any value because many audit nonconformances live in the gap between significant differences and actual requirements. For me, if one document has a requirement that is not in the other, then the difference is significant, and would result in an audit nonconformance.

I prefer the approach in CEN/TR 17223:2018 which maps the requirements of the EU-MDR/IVDR Article 10 to the corresponding elements of ISO 13485:2016. The attributes are "fully covered", "partially covered", or "not covered". With partially covered, there is an explanation of the gap.

If I were to map 21 CFR 820.181 to ISO 13485:2016 Section 4.2.3 my conclusion is:
Partially Covered – ISO 13485:2016 doesn't require document control, quality assurance procedures, labeling specifications, or procedures for maintenance.

Specifically –
820.182 requires "each DMR is prepared and approved in accordance with 820.40". 4.2.3 does not have a document control requirement.

820.181(a) requires device specification while 4.2.3(b) says, "specifications for the product". I consider these to be the same.

820.181(b) requires production process specifications while 4.2.3(c) says, "specifications or procedures for manufacturing, packaging, storage, handling and distribution". I consider these to be the same.

820.181(c) requires quality assurance procedures and specifications while 4.2.3 doesn't.

820.181(d) requires labeling specifications while 4.2.3(a) requires a general description of the labeling, not the labeling specifications.

820.181(e) requires maintenance procedures and methods while 4.2.3 does not.

One could map the requirements from ISO 13485:2016, 4.2.3 to 820.181 and create a similar list of differences.

The issue for me, is that there are significant differences and they should result in audit nonconformances if a manufacturer asserted that ISO 13485:2016, 4.2.3 is the same as (or without significant differences from) 820.181. (Hint: I would expect an FDA Investigator to issue a 483.)

While not asked, I'll also comment on EN ISO 13485:2016/AC2018. In particular, ISO 13485:2016, clause 4.2.3 does not satisfy EN ISO 13485:2016/AC2018, clause 4.2.3 when applied to the MDD Annex II.

The point here is most medical device manufacturers implement MDD Annex II so there are two "two hops" from QSR to the MDD QMS.

Lena,

I had planned to concur with Richard in his appraisal of the comparison of 21 CFR 820.181, Device Master Record, and ISO 13485 Section 4.2.3, Medical Device File. However, my reasoning is not the same as Richard's and is more closely related to your question to Richard.

A few disclaimers.
I have not read the AAMI document, so I'm relying on Richard's characterization of "No significant difference".

I have not discussed my opinion with Richard. My opinions are mine.

FDA's project is, in my opinion, ill-conceived and looks to me like a solution looking for a problem. I have heard three things that bear on my opinion.

Without the support of an FDA Commissioner, the project will not move forward (there is an acting Commissioner now).

FDA had planned to release the first elements of this project in April or May of 2019, but has not. This suggests to me that the project is on hold.

ISO intends to revise 13485 before FDA could complete its work.

The phrase "No significant difference" doesn't add any value because many audit nonconformances live in the gap between significant differences and actual requirements. For me, if one document has a requirement that is not in the other, then the difference is significant, and would result in an audit nonconformance.

I prefer the approach in CEN/TR 17223:2018 which maps the requirements of the EU-MDR/IVDR Article 10 to the corresponding elements of ISO 13485:2016. The attributes are "fully covered", "partially covered", or "not covered". With partially covered, there is an explanation of the gap.

If I were to map 21 CFR 820.181 to ISO 13485:2016 Section 4.2.3 my conclusion is:
Partially Covered – ISO 13485:2016 doesn't require document control, quality assurance procedures, labeling specifications, or procedures for maintenance.

Specifically –
820.182 requires "each DMR is prepared and approved in accordance with 820.40". 4.2.3 does not have a document control requirement.

820.181(a) requires device specification while 4.2.3(b) says, "specifications for the product". I consider these to be the same.

820.181(b) requires production process specifications while 4.2.3(c) says, "specifications or procedures for manufacturing, packaging, storage, handling and distribution". I consider these to be the same.

820.181(c) requires quality assurance procedures and specifications while 4.2.3 doesn't.

820.181(d) requires labeling specifications while 4.2.3(a) requires a general description of the labeling, not the labeling specifications.

820.181(e) requires maintenance procedures and methods while 4.2.3 does not.

One could map the requirements from ISO 13485:2016, 4.2.3 to 820.181 and create a similar list of differences.

The issue for me, is that there are significant differences and they should result in audit nonconformances if a manufacturer asserted that ISO 13485:2016, 4.2.3 is the same as (or without significant differences from) 820.181. (Hint: I would expect an FDA Investigator to issue a 483.)

While not asked, I'll also comment on EN ISO 13485:2016/AC2018. In particular, ISO 13485:2016, clause 4.2.3 does not satisfy EN ISO 13485:2016/AC2018, clause 4.2.3 when applied to the MDD Annex II.

The point here is most medical device manufacturers implement MDD Annex II so there are two "two hops" from QSR to the MDD QMS.

Lena,

I had planned to concur with Richard in his appraisal of the comparison of 21 CFR 820.181, Device Master Record, and ISO 13485 Section 4.2.3, Medical Device File. However, my reasoning is not the same as Richard's and is more closely related to your question to Richard.

A few disclaimers.
I have not read the AAMI document, so I'm relying on Richard's characterization of "No significant difference".

I have not discussed my opinion with Richard. My opinions are mine.

FDA's project is, in my opinion, ill-conceived and looks to me like a solution looking for a problem. I have heard three things that bear on my opinion.

Without the support of an FDA Commissioner, the project will not move forward (there is an acting Commissioner now).

FDA had planned to release the first elements of this project in April or May of 2019, but has not. This suggests to me that the project is on hold.

ISO intends to revise 13485 before FDA could complete its work.

The phrase "No significant difference" doesn't add any value because many audit nonconformances live in the gap between significant differences and actual requirements. For me, if one document has a requirement that is not in the other, then the difference is significant, and would result in an audit nonconformance.

I prefer the approach in CEN/TR 17223:2018 which maps the requirements of the EU-MDR/IVDR Article 10 to the corresponding elements of ISO 13485:2016. The attributes are "fully covered", "partially covered", or "not covered". With partially covered, there is an explanation of the gap.

If I were to map 21 CFR 820.181 to ISO 13485:2016 Section 4.2.3 my conclusion is:
Partially Covered – ISO 13485:2016 doesn't require document control, quality assurance procedures, labeling specifications, or procedures for maintenance.

Specifically –
820.182 requires "each DMR is prepared and approved in accordance with 820.40". 4.2.3 does not have a document control requirement.

820.181(a) requires device specification while 4.2.3(b) says, "specifications for the product". I consider these to be the same.

820.181(b) requires production process specifications while 4.2.3(c) says, "specifications or procedures for manufacturing, packaging, storage, handling and distribution". I consider these to be the same.

820.181(c) requires quality assurance procedures and specifications while 4.2.3 doesn't.

820.181(d) requires labeling specifications while 4.2.3(a) requires a general description of the labeling, not the labeling specifications.

820.181(e) requires maintenance procedures and methods while 4.2.3 does not.

One could map the requirements from ISO 13485:2016, 4.2.3 to 820.181 and create a similar list of differences.

The issue for me, is that there are significant differences and they should result in audit nonconformances if a manufacturer asserted that ISO 13485:2016, 4.2.3 is the same as (or without significant differences from) 820.181. (Hint: I would expect an FDA Investigator to issue a 483.)

While not asked, I'll also comment on EN ISO 13485:2016/AC2018. In particular, ISO 13485:2016, clause 4.2.3 does not satisfy EN ISO 13485:2016/AC2018, clause 4.2.3 when applied to the MDD Annex II.

The point here is most medical device manufacturers implement MDD Annex II so there are two "two hops" from QSR to the MDD QMS.

Lena,

I had planned to concur with Richard in his appraisal of the comparison of 21 CFR 820.181, Device Master Record, and ISO 13485 Section 4.2.3, Medical Device File. However, my reasoning is not the same as Richard's and is more closely related to your question to Richard.

A few disclaimers.
I have not read the AAMI document, so I'm relying on Richard's characterization of "No significant difference".

I have not discussed my opinion with Richard. My opinions are mine.

FDA's project is, in my opinion, ill-conceived and looks to me like a solution looking for a problem. I have heard three things that bear on my opinion.

Without the support of an FDA Commissioner, the project will not move forward (there is an acting Commissioner now).

FDA had planned to release the first elements of this project in April or May of 2019, but has not. This suggests to me that the project is on hold.

ISO intends to revise 13485 before FDA could complete its work.

The phrase "No significant difference" doesn't add any value because many audit nonconformances live in the gap between significant differences and actual requirements. For me, if one document has a requirement that is not in the other, then the difference is significant, and would result in an audit nonconformance.

I prefer the approach in CEN/TR 17223:2018 which maps the requirements of the EU-MDR/IVDR Article 10 to the corresponding elements of ISO 13485:2016. The attributes are "fully covered", "partially covered", or "not covered". With partially covered, there is an explanation of the gap.

If I were to map 21 CFR 820.181 to ISO 13485:2016 Section 4.2.3 my conclusion is:
Partially Covered – ISO 13485:2016 doesn't require document control, quality assurance procedures, labeling specifications, or procedures for maintenance.

Specifically –
820.182 requires "each DMR is prepared and approved in accordance with 820.40". 4.2.3 does not have a document control requirement.

820.181(a) requires device specification while 4.2.3(b) says, "specifications for the product". I consider these to be the same.

820.181(b) requires production process specifications while 4.2.3(c) says, "specifications or procedures for manufacturing, packaging, storage, handling and distribution". I consider these to be the same.

820.181(c) requires quality assurance procedures and specifications while 4.2.3 doesn't.

820.181(d) requires labeling specifications while 4.2.3(a) requires a general description of the labeling, not the labeling specifications.

820.181(e) requires maintenance procedures and methods while 4.2.3 does not.

One could map the requirements from ISO 13485:2016, 4.2.3 to 820.181 and create a similar list of differences.

The issue for me, is that there are significant differences and they should result in audit nonconformances if a manufacturer asserted that ISO 13485:2016, 4.2.3 is the same as (or without significant differences from) 820.181. (Hint: I would expect an FDA Investigator to issue a 483.)

While not asked, I'll also comment on EN ISO 13485:2016/AC2018. In particular, ISO 13485:2016, clause 4.2.3 does not satisfy EN ISO 13485:2016/AC2018, clause 4.2.3 when applied to the MDD Annex II.

The point here is most medical device manufacturers implement MDD Annex II so there are two "two hops" from QSR to the MDD QMS.

Lena,

I had planned to concur with Richard in his appraisal of the comparison of 21 CFR 820.181, Device Master Record, and ISO 13485 Section 4.2.3, Medical Device File. However, my reasoning is not the same as Richard's and is more closely related to your question to Richard.

A few disclaimers.
I have not read the AAMI document, so I'm relying on Richard's characterization of "No significant difference".

I have not discussed my opinion with Richard. My opinions are mine.

FDA's project is, in my opinion, ill-conceived and looks to me like a solution looking for a problem. I have heard three things that bear on my opinion.

Without the support of an FDA Commissioner, the project will not move forward (there is an acting Commissioner now).

FDA had planned to release the first elements of this project in April or May of 2019, but has not. This suggests to me that the project is on hold.

ISO intends to revise 13485 before FDA could complete its work.

The phrase "No significant difference" doesn't add any value because many audit nonconformances live in the gap between significant differences and actual requirements. For me, if one document has a requirement that is not in the other, then the difference is significant, and would result in an audit nonconformance.

I prefer the approach in CEN/TR 17223:2018 which maps the requirements of the EU-MDR/IVDR Article 10 to the corresponding elements of ISO 13485:2016. The attributes are "fully covered", "partially covered", or "not covered". With partially covered, there is an explanation of the gap.

If I were to map 21 CFR 820.181 to ISO 13485:2016 Section 4.2.3 my conclusion is:
Partially Covered – ISO 13485:2016 doesn't require document control, quality assurance procedures, labeling specifications, or procedures for maintenance.

Specifically –
820.182 requires "each DMR is prepared and approved in accordance with 820.40". 4.2.3 does not have a document control requirement.

820.181(a) requires device specification while 4.2.3(b) says, "specifications for the product". I consider these to be the same.

820.181(b) requires production process specifications while 4.2.3(c) says, "specifications or procedures for manufacturing, packaging, storage, handling and distribution". I consider these to be the same.

820.181(c) requires quality assurance procedures and specifications while 4.2.3 doesn't.

820.181(d) requires labeling specifications while 4.2.3(a) requires a general description of the labeling, not the labeling specifications.

820.181(e) requires maintenance procedures and methods while 4.2.3 does not.

One could map the requirements from ISO 13485:2016, 4.2.3 to 820.181 and create a similar list of differences.

The issue for me, is that there are significant differences and they should result in audit nonconformances if a manufacturer asserted that ISO 13485:2016, 4.2.3 is the same as (or without significant differences from) 820.181. (Hint: I would expect an FDA Investigator to issue a 483.)

While not asked, I'll also comment on EN ISO 13485:2016/AC2018. In particular, ISO 13485:2016, clause 4.2.3 does not satisfy EN ISO 13485:2016/AC2018, clause 4.2.3 when applied to the MDD Annex II.

The point here is most medical device manufacturers implement MDD Annex II so there are two "two hops" from QSR to the MDD QMS.

Lena,

I had planned to concur with Richard in his appraisal of the comparison of 21 CFR 820.181, Device Master Record, and ISO 13485 Section 4.2.3, Medical Device File. However, my reasoning is not the same as Richard's and is more closely related to your question to Richard.

A few disclaimers.
I have not read the AAMI document, so I'm relying on Richard's characterization of "No significant difference".

I have not discussed my opinion with Richard. My opinions are mine.

FDA's project is, in my opinion, ill-conceived and looks to me like a solution looking for a problem. I have heard three things that bear on my opinion.

Without the support of an FDA Commissioner, the project will not move forward (there is an acting Commissioner now).

FDA had planned to release the first elements of this project in April or May of 2019, but has not. This suggests to me that the project is on hold.

ISO intends to revise 13485 before FDA could complete its work.

The phrase "No significant difference" doesn't add any value because many audit nonconformances live in the gap between significant differences and actual requirements. For me, if one document has a requirement that is not in the other, then the difference is significant, and would result in an audit nonconformance.

I prefer the approach in CEN/TR 17223:2018 which maps the requirements of the EU-MDR/IVDR Article 10 to the corresponding elements of ISO 13485:2016. The attributes are "fully covered", "partially covered", or "not covered". With partially covered, there is an explanation of the gap.

If I were to map 21 CFR 820.181 to ISO 13485:2016 Section 4.2.3 my conclusion is:
Partially Covered – ISO 13485:2016 doesn't require document control, quality assurance procedures, labeling specifications, or procedures for maintenance.

Specifically –
820.182 requires "each DMR is prepared and approved in accordance with 820.40". 4.2.3 does not have a document control requirement.

820.181(a) requires device specification while 4.2.3(b) says, "specifications for the product". I consider these to be the same.

820.181(b) requires production process specifications while 4.2.3(c) says, "specifications or procedures for manufacturing, packaging, storage, handling and distribution". I consider these to be the same.

820.181(c) requires quality assurance procedures and specifications while 4.2.3 doesn't.

820.181(d) requires labeling specifications while 4.2.3(a) requires a general description of the labeling, not the labeling specifications.

820.181(e) requires maintenance procedures and methods while 4.2.3 does not.

One could map the requirements from ISO 13485:2016, 4.2.3 to 820.181 and create a similar list of differences.

The issue for me, is that there are significant differences and they should result in audit nonconformances if a manufacturer asserted that ISO 13485:2016, 4.2.3 is the same as (or without significant differences from) 820.181. (Hint: I would expect an FDA Investigator to issue a 483.)

While not asked, I'll also comment on EN ISO 13485:2016/AC2018. In particular, ISO 13485:2016, clause 4.2.3 does not satisfy EN ISO 13485:2016/AC2018, clause 4.2.3 when applied to the MDD Annex II.

The point here is most medical device manufacturers implement MDD Annex II so there are two "two hops" from QSR to the MDD QMS.

Lena,

I had planned to concur with Richard in his appraisal of the comparison of 21 CFR 820.181, Device Master Record, and ISO 13485 Section 4.2.3, Medical Device File. However, my reasoning is not the same as Richard's and is more closely related to your question to Richard.

A few disclaimers.
I have not read the AAMI document, so I'm relying on Richard's characterization of "No significant difference".

I have not discussed my opinion with Richard. My opinions are mine.

FDA's project is, in my opinion, ill-conceived and looks to me like a solution looking for a problem. I have heard three things that bear on my opinion.

Without the support of an FDA Commissioner, the project will not move forward (there is an acting Commissioner now).

FDA had planned to release the first elements of this project in April or May of 2019, but has not. This suggests to me that the project is on hold.

ISO intends to revise 13485 before FDA could complete its work.

The phrase "No significant difference" doesn't add any value because many audit nonconformances live in the gap between significant differences and actual requirements. For me, if one document has a requirement that is not in the other, then the difference is significant, and would result in an audit nonconformance.

I prefer the approach in CEN/TR 17223:2018 which maps the requirements of the EU-MDR/IVDR Article 10 to the corresponding elements of ISO 13485:2016. The attributes are "fully covered", "partially covered", or "not covered". With partially covered, there is an explanation of the gap.

If I were to map 21 CFR 820.181 to ISO 13485:2016 Section 4.2.3 my conclusion is:
Partially Covered – ISO 13485:2016 doesn't require document control, quality assurance procedures, labeling specifications, or procedures for maintenance.

Specifically –
820.182 requires "each DMR is prepared and approved in accordance with 820.40". 4.2.3 does not have a document control requirement.

820.181(a) requires device specification while 4.2.3(b) says, "specifications for the product". I consider these to be the same.

820.181(b) requires production process specifications while 4.2.3(c) says, "specifications or procedures for manufacturing, packaging, storage, handling and distribution". I consider these to be the same.

820.181(c) requires quality assurance procedures and specifications while 4.2.3 doesn't.

820.181(d) requires labeling specifications while 4.2.3(a) requires a general description of the labeling, not the labeling specifications.

820.181(e) requires maintenance procedures and methods while 4.2.3 does not.

One could map the requirements from ISO 13485:2016, 4.2.3 to 820.181 and create a similar list of differences.

The issue for me, is that there are significant differences and they should result in audit nonconformances if a manufacturer asserted that ISO 13485:2016, 4.2.3 is the same as (or without significant differences from) 820.181. (Hint: I would expect an FDA Investigator to issue a 483.)

While not asked, I'll also comment on EN ISO 13485:2016/AC2018. In particular, ISO 13485:2016, clause 4.2.3 does not satisfy EN ISO 13485:2016/AC2018, clause 4.2.3 when applied to the MDD Annex II.

The point here is most medical device manufacturers implement MDD Annex II so there are two "two hops" from QSR to the MDD QMS.

Lena,

I had planned to concur with Richard in his appraisal of the comparison of 21 CFR 820.181, Device Master Record, and ISO 13485 Section 4.2.3, Medical Device File. However, my reasoning is not the same as Richard's and is more closely related to your question to Richard.

A few disclaimers.
I have not read the AAMI document, so I'm relying on Richard's characterization of "No significant difference".

I have not discussed my opinion with Richard. My opinions are mine.

FDA's project is, in my opinion, ill-conceived and looks to me like a solution looking for a problem. I have heard three things that bear on my opinion.

Without the support of an FDA Commissioner, the project will not move forward (there is an acting Commissioner now).

FDA had planned to release the first elements of this project in April or May of 2019, but has not. This suggests to me that the project is on hold.

ISO intends to revise 13485 before FDA could complete its work.

The phrase "No significant difference" doesn't add any value because many audit nonconformances live in the gap between significant differences and actual requirements. For me, if one document has a requirement that is not in the other, then the difference is significant, and would result in an audit nonconformance.

I prefer the approach in CEN/TR 17223:2018 which maps the requirements of the EU-MDR/IVDR Article 10 to the corresponding elements of ISO 13485:2016. The attributes are "fully covered", "partially covered", or "not covered". With partially covered, there is an explanation of the gap.

If I were to map 21 CFR 820.181 to ISO 13485:2016 Section 4.2.3 my conclusion is:
Partially Covered – ISO 13485:2016 doesn't require document control, quality assurance procedures, labeling specifications, or procedures for maintenance.

Specifically –
820.182 requires "each DMR is prepared and approved in accordance with 820.40". 4.2.3 does not have a document control requirement.

820.181(a) requires device specification while 4.2.3(b) says, "specifications for the product". I consider these to be the same.

820.181(b) requires production process specifications while 4.2.3(c) says, "specifications or procedures for manufacturing, packaging, storage, handling and distribution". I consider these to be the same.

820.181(c) requires quality assurance procedures and specifications while 4.2.3 doesn't.

820.181(d) requires labeling specifications while 4.2.3(a) requires a general description of the labeling, not the labeling specifications.

820.181(e) requires maintenance procedures and methods while 4.2.3 does not.

One could map the requirements from ISO 13485:2016, 4.2.3 to 820.181 and create a similar list of differences.

The issue for me, is that there are significant differences and they should result in audit nonconformances if a manufacturer asserted that ISO 13485:2016, 4.2.3 is the same as (or without significant differences from) 820.181. (Hint: I would expect an FDA Investigator to issue a 483.)

While not asked, I'll also comment on EN ISO 13485:2016/AC2018. In particular, ISO 13485:2016, clause 4.2.3 does not satisfy EN ISO 13485:2016/AC2018, clause 4.2.3 when applied to the MDD Annex II.

The point here is most medical device manufacturers implement MDD Annex II so there are two "two hops" from QSR to the MDD QMS.

Lena,

I had planned to concur with Richard in his appraisal of the comparison of 21 CFR 820.181, Device Master Record, and ISO 13485 Section 4.2.3, Medical Device File. However, my reasoning is not the same as Richard's and is more closely related to your question to Richard.

A few disclaimers.
I have not read the AAMI document, so I'm relying on Richard's characterization of "No significant difference".

I have not discussed my opinion with Richard. My opinions are mine.

FDA's project is, in my opinion, ill-conceived and looks to me like a solution looking for a problem. I have heard three things that bear on my opinion.

Without the support of an FDA Commissioner, the project will not move forward (there is an acting Commissioner now).

FDA had planned to release the first elements of this project in April or May of 2019, but has not. This suggests to me that the project is on hold.

ISO intends to revise 13485 before FDA could complete its work.

The phrase "No significant difference" doesn't add any value because many audit nonconformances live in the gap between significant differences and actual requirements. For me, if one document has a requirement that is not in the other, then the difference is significant, and would result in an audit nonconformance.

I prefer the approach in CEN/TR 17223:2018 which maps the requirements of the EU-MDR/IVDR Article 10 to the corresponding elements of ISO 13485:2016. The attributes are "fully covered", "partially covered", or "not covered". With partially covered, there is an explanation of the gap.

If I were to map 21 CFR 820.181 to ISO 13485:2016 Section 4.2.3 my conclusion is:
Partially Covered – ISO 13485:2016 doesn't require document control, quality assurance procedures, labeling specifications, or procedures for maintenance.

Specifically –
820.182 requires "each DMR is prepared and approved in accordance with 820.40". 4.2.3 does not have a document control requirement.

820.181(a) requires device specification while 4.2.3(b) says, "specifications for the product". I consider these to be the same.

820.181(b) requires production process specifications while 4.2.3(c) says, "specifications or procedures for manufacturing, packaging, storage, handling and distribution". I consider these to be the same.

820.181(c) requires quality assurance procedures and specifications while 4.2.3 doesn't.

820.181(d) requires labeling specifications while 4.2.3(a) requires a general description of the labeling, not the labeling specifications.

820.181(e) requires maintenance procedures and methods while 4.2.3 does not.

One could map the requirements from ISO 13485:2016, 4.2.3 to 820.181 and create a similar list of differences.

The issue for me, is that there are significant differences and they should result in audit nonconformances if a manufacturer asserted that ISO 13485:2016, 4.2.3 is the same as (or without significant differences from) 820.181. (Hint: I would expect an FDA Investigator to issue a 483.)

While not asked, I'll also comment on EN ISO 13485:2016/AC2018. In particular, ISO 13485:2016, clause 4.2.3 does not satisfy EN ISO 13485:2016/AC2018, clause 4.2.3 when applied to the MDD Annex II.

The point here is most medical device manufacturers implement MDD Annex II so there are two "two hops" from QSR to the MDD QMS.

Lena,

I had planned to concur with Richard in his appraisal of the comparison of 21 CFR 820.181, Device Master Record, and ISO 13485 Section 4.2.3, Medical Device File. However, my reasoning is not the same as Richard's and is more closely related to your question to Richard.

A few disclaimers.
I have not read the AAMI document, so I'm relying on Richard's characterization of "No significant difference".

I have not discussed my opinion with Richard. My opinions are mine.

FDA's project is, in my opinion, ill-conceived and looks to me like a solution looking for a problem. I have heard three things that bear on my opinion.

Without the support of an FDA Commissioner, the project will not move forward (there is an acting Commissioner now).

FDA had planned to release the first elements of this project in April or May of 2019, but has not. This suggests to me that the project is on hold.

ISO intends to revise 13485 before FDA could complete its work.

The phrase "No significant difference" doesn't add any value because many audit nonconformances live in the gap between significant differences and actual requirements. For me, if one document has a requirement that is not in the other, then the difference is significant, and would result in an audit nonconformance.

I prefer the approach in CEN/TR 17223:2018 which maps the requirements of the EU-MDR/IVDR Article 10 to the corresponding elements of ISO 13485:2016. The attributes are "fully covered", "partially covered", or "not covered". With partially covered, there is an explanation of the gap.

If I were to map 21 CFR 820.181 to ISO 13485:2016 Section 4.2.3 my conclusion is:
Partially Covered – ISO 13485:2016 doesn't require document control, quality assurance procedures, labeling specifications, or procedures for maintenance.

Specifically –
820.182 requires "each DMR is prepared and approved in accordance with 820.40". 4.2.3 does not have a document control requirement.

820.181(a) requires device specification while 4.2.3(b) says, "specifications for the product". I consider these to be the same.

820.181(b) requires production process specifications while 4.2.3(c) says, "specifications or procedures for manufacturing, packaging, storage, handling and distribution". I consider these to be the same.

820.181(c) requires quality assurance procedures and specifications while 4.2.3 doesn't.

820.181(d) requires labeling specifications while 4.2.3(a) requires a general description of the labeling, not the labeling specifications.

820.181(e) requires maintenance procedures and methods while 4.2.3 does not.

One could map the requirements from ISO 13485:2016, 4.2.3 to 820.181 and create a similar list of differences.

The issue for me, is that there are significant differences and they should result in audit nonconformances if a manufacturer asserted that ISO 13485:2016, 4.2.3 is the same as (or without significant differences from) 820.181. (Hint: I would expect an FDA Investigator to issue a 483.)

While not asked, I'll also comment on EN ISO 13485:2016/AC2018. In particular, ISO 13485:2016, clause 4.2.3 does not satisfy EN ISO 13485:2016/AC2018, clause 4.2.3 when applied to the MDD Annex II.

The point here is most medical device manufacturers implement MDD Annex II so there are two "two hops" from QSR to the MDD QMS.

Lena,

I had planned to concur with Richard in his appraisal of the comparison of 21 CFR 820.181, Device Master Record, and ISO 13485 Section 4.2.3, Medical Device File. However, my reasoning is not the same as Richard's and is more closely related to your question to Richard.

A few disclaimers.
I have not read the AAMI document, so I'm relying on Richard's characterization of "No significant difference".

I have not discussed my opinion with Richard. My opinions are mine.

FDA's project is, in my opinion, ill-conceived and looks to me like a solution looking for a problem. I have heard three things that bear on my opinion.

Without the support of an FDA Commissioner, the project will not move forward (there is an acting Commissioner now).

FDA had planned to release the first elements of this project in April or May of 2019, but has not. This suggests to me that the project is on hold.

ISO intends to revise 13485 before FDA could complete its work.

The phrase "No significant difference" doesn't add any value because many audit nonconformances live in the gap between significant differences and actual requirements. For me, if one document has a requirement that is not in the other, then the difference is significant, and would result in an audit nonconformance.

I prefer the approach in CEN/TR 17223:2018 which maps the requirements of the EU-MDR/IVDR Article 10 to the corresponding elements of ISO 13485:2016. The attributes are "fully covered", "partially covered", or "not covered". With partially covered, there is an explanation of the gap.

If I were to map 21 CFR 820.181 to ISO 13485:2016 Section 4.2.3 my conclusion is:
Partially Covered – ISO 13485:2016 doesn't require document control, quality assurance procedures, labeling specifications, or procedures for maintenance.

Specifically –
820.182 requires "each DMR is prepared and approved in accordance with 820.40". 4.2.3 does not have a document control requirement.

820.181(a) requires device specification while 4.2.3(b) says, "specifications for the product". I consider these to be the same.

820.181(b) requires production process specifications while 4.2.3(c) says, "specifications or procedures for manufacturing, packaging, storage, handling and distribution". I consider these to be the same.

820.181(c) requires quality assurance procedures and specifications while 4.2.3 doesn't.

820.181(d) requires labeling specifications while 4.2.3(a) requires a general description of the labeling, not the labeling specifications.

820.181(e) requires maintenance procedures and methods while 4.2.3 does not.

One could map the requirements from ISO 13485:2016, 4.2.3 to 820.181 and create a similar list of differences.

The issue for me, is that there are significant differences and they should result in audit nonconformances if a manufacturer asserted that ISO 13485:2016, 4.2.3 is the same as (or without significant differences from) 820.181. (Hint: I would expect an FDA Investigator to issue a 483.)

While not asked, I'll also comment on EN ISO 13485:2016/AC2018. In particular, ISO 13485:2016, clause 4.2.3 does not satisfy EN ISO 13485:2016/AC2018, clause 4.2.3 when applied to the MDD Annex II.

The point here is most medical device manufacturers implement MDD Annex II so there are two "two hops" from QSR to the MDD QMS.