In 510k application do we submit documents showing compliance with 21CFRPart820

R

regmeddevices

#1
Hi Again,
I need your help with one more thing. As I mentioned that we are submitting 510k of a class II device.

Apart from all the documents required by FDA for a traditional 510k application.

Do we also need to submit all documents (like a plan in place on how we are going to handle adverse events, servicing, training, purchasing data, quality plan, internal audit etc) that show our compliance with various requirements of 21 CFR part 820? and do we need to submit CAPA to the FDA? OR these documents should be maintained for records which will be checked by FDA in an inspection. Any help will be highly appreciated.
:thanx:
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi Again,
I need your help with one more thing. As I mentioned that we are submitting 510k of a class II device.

Apart from all the documents required by FDA for a traditional 510k application.

Do we also need to submit all documents (like a plan in place on how we are going to handle adverse events, servicing, training, purchasing data, quality plan, internal audit etc) that show our compliance with various requirements of 21 CFR part 820? and do we need to submit CAPA to the FDA? OR these documents should be maintained for records which will be checked by FDA in an inspection. Any help will be highly appreciated.
:thanx:
these documents should be maintained for records which will be checked by FDA in an inspection.
 

Sam Lazzara

Trusted Information Resource
#3
It is instructive to see what FDA writes in a typical 510(k) clearance letter (see below)

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CER Part 820); and if applicable, the electronic product radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000-1050.

Side Note
The Special 510(k) is used for device modifications and utilizes the design controls aspect of the Quality System (QS) regulation (21 CFR 820.30). For Special 510(k)s it is required to provide a 21 CFR 820.30 design control declaration that reads something like this:

I certify that, in my capacity as {TITLE} of {COMPANY NAME}, I believe to the best of my knowledge that:
• As required by the risk analysis, all design verification and design validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met; and
• The manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.
 
Last edited:
M

MIREGMGR

#4
Apart from all the documents required by FDA for a traditional 510k application. Do we also need to submit all documents (like a plan in place on how we are going to handle adverse events, servicing, training, purchasing data, quality plan, internal audit etc) that show our compliance with various requirements of 21 CFR part 820? (...)
Several guidances at the CDRH site outline the elements of a 510(k). Generally, unless directed otherwise in your specific instance, that's all you submit. No other material.

Anything else you send will just clog up the works.

But, you do have to have your complete QMS in place, documented and operational.
 
P

paullarn

#6
Hi Guys,
I am preparing special 510K documents for a glucose monitor and stuck on :

"A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on
the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities
required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should
include:
i) A statement signed by the individual responsible, that, as required by the risk
analysis, all verification and validation activities were performed by the designated
individual(s) and the results demonstrated that the predetermined acceptance criteria
were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in
conformance with design control procedure requirements as specified in 21 CFR
820.30 and the records are available for review."

Based on your reply above, is my understand correct that all I have to give them for all of the above in quotes is:

"I certify that, in my capacity as {TITLE} of {COMPANY NAME}, I believe to the best of my knowledge that:
• As required by the risk analysis, all design verification and design validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met; and
• The manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review."


Correct?
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
What about? :
-Identification of any manufacturing process controls added/changed as a result of
the modifications to the device (e.g., new work instructions, operator retraining,
equipment re-qualification, new inspection aids, additional sampling, etc.)


and

- Identification of changes made to the Device Master Record (DMR) related to the
modified device -- provide document number(s) and revision level(s);

and
- Documentation of final design review and sign-off of modified device by
designated individual(s); and


- Declaration of conformity with design controls6.
 
Last edited by a moderator:
P

paullarn

#7
It is instructive to see what FDA writes in a typical 510(k) clearance letter (see below)

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CER Part 820); and if applicable, the electronic product radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000-1050.

Side Note
The Special 510(k) is used for device modifications and utilizes the design controls aspect of the Quality System (QS) regulation (21 CFR 820.30). For Special 510(k)s it is required to provide a 21 CFR 820.30 design control declaration that reads something like this:

I certify that, in my capacity as {TITLE} of {COMPANY NAME}, I believe to the best of my knowledge that:
• As required by the risk analysis, all design verification and design validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met; and
• The manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.
Hi,
I am preparing special 510K documents for a glucose monitor and stuck on :

"A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on
the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities
required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should
include:
i) A statement signed by the individual responsible, that, as required by the risk
analysis, all verification and validation activities were performed by the designated
individual(s) and the results demonstrated that the predetermined acceptance criteria
were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in
conformance with design control procedure requirements as specified in 21 CFR
820.30 and the records are available for review."

Based on your reply above, is my understand correct that all I have to give them for all of the above in quotes is:

"I certify that, in my capacity as {TITLE} of {COMPANY NAME}, I believe to the best of my knowledge that:
• As required by the risk analysis, all design verification and design validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met; and
• The manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review."


Correct?
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
What about? :
-Identification of any manufacturing process controls added/changed as a result of
the modifications to the device (e.g., new work instructions, operator retraining,
equipment re-qualification, new inspection aids, additional sampling, etc.)


and

- Identification of changes made to the Device Master Record (DMR) related to the
modified device -- provide document number(s) and revision level(s);

and
- Documentation of final design review and sign-off of modified device by
designated individual(s); and


- Declaration of conformity with design controls.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Hi Guys,
I am preparing special 510K documents for a glucose monitor and stuck on :

"A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on
the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities
required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should
include:
i) A statement signed by the individual responsible, that, as required by the risk
analysis, all verification and validation activities were performed by the designated
individual(s) and the results demonstrated that the predetermined acceptance criteria
were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in
conformance with design control procedure requirements as specified in 21 CFR
820.30 and the records are available for review."

Based on your reply above, is my understand correct that all I have to give them for all of the above in quotes is:

"I certify that, in my capacity as {TITLE} of {COMPANY NAME}, I believe to the best of my knowledge that:
? As required by the risk analysis, all design verification and design validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met; and
? The manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review."


Correct?
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
What about? :
-Identification of any manufacturing process controls added/changed as a result of
the modifications to the device (e.g., new work instructions, operator retraining,
equipment re-qualification, new inspection aids, additional sampling, etc.)


and

- Identification of changes made to the Device Master Record (DMR) related to the
modified device -- provide document number(s) and revision level(s);

and
- Documentation of final design review and sign-off of modified device by
designated individual(s); and


- Declaration of conformity with design controls6.
All the answers are here:

http://www.fda.gov/MedicalDevices/D...sions/PremarketNotification510k/ucm134573.htm

Good luck,
Ronen.
 
E

ejacob3

#9
I think there is an explicit answer missing here. Are design controls required for a 510k.

is the information, risk review, protocols etc required to be completed under design controls?

For a traditional 510k.
 
M

MIREGMGR

#10
It's logically fundamental to 21CFR 820 that, for a device type for which design controls are required, those design controls must be in effect during device design. You can't apply for a 510(k) until you have a device design...you can't ask for clearance on a concept...so the answer to your question is yes.
 
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