Why the FDA requests Lot Number in Testing Reports

R

regfocus

#1
FDA request medical device's lot number in surgical mask performance test lab reports and biocompatibility test reports during our 510k submission.

Anybody know if that's FDA's trap for seizing any Lot number deficiency issue?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Naturally you have to record what units were tested in any testing program. How else would the test results be able to be provably associated with your development/production product stream?

What do you mean by "trap"? Do you have information that they are unlikely to find out except by using a "trap"?
 

somashekar

Staff member
Admin
#4
FDA request medical device's lot number in surgical mask performance test lab reports and biocompatibility test reports during our 510k submission.

Anybody know if that's FDA's trap for seizing any Lot number deficiency issue?
Performance test lab reports and biocompatibility test reports, are type test reports that are taken up on production sample to assure that they meet the design specification. A lot number assures that the test samples come from a specific production lot, which has all the relevant DHR information. Unlike routine tests, these are not performed on regular production lots.
Therefore the validity of these reports at any future time can be assessed based on the study and comparison of the ongoing lot number DHR. The reviewer, as well as the company can assess the validity or decide to retest based on significance of the changes made. These changes reflect into the DHR.
 

Michael Malis

Quite Involved in Discussions
#5
... A lot number assures that the test samples come from a specific production lot, which has all the relevant DHR information. Unlike routine tests, these are not performed on regular production lots.
Therefore the validity of these reports at any future time can be assessed based on the study and comparison of the ongoing lot number DHR. The reviewer, as well as the company can assess the validity or decide to retest based on significance of the changes made. These changes reflect into the DHR.
As stated above by 3 individuals, lot numbers are used for product Material Traceability. And based on the product, some of the tests ARE performed on regular lots. It is important to remember, that biocompatibility can be affected by raw material. For example, if we have questionable results on the product (made from Polycarbonate, for example) that was perfectly acceptable before, we can evaluate raw material lot to check for the presence of contamination.
 
R

regfocus

#6
Thank everybody's help. I understand ID/Lot/Batch is necessary in the testing report. My question is if FDA concern the tested samples came from single batch/lot or multiple lots.

I saw a FDA guidance "Guidance For Conducting Stability Testing To Support An Expiration Date Labeling Claim For Medical Gloves Draft"

It said,

3. Preparation and Sampling
3.1 An appropriate number of boxes of finished product (i.e., after final packaging and, if applicable, after
sterilization) should be randomly selected from each sampling lot on the day of manufacture.


Does that mean if only single lot was tested will not be accepted by FDA for 510k submission?




Naturally you have to record what units were tested in any testing program. How else would the test results be able to be provably associated with your development/production product stream?

What do you mean by "trap"? Do you have information that they are unlikely to find out except by using a "trap"?
 
M

MIREGMGR

#7
My understanding of the guidance in question is that FDA wants the testing process to fairly represent the production variability of a day's production.

So, if your testing is representative to that extent, they probably will accept your explanation.

If on the other hand it appears to them that your testing essentially was a "snapshot" of production, and there is no evidence that it was fully representative of production variability, they might not accept it.
 
R

regfocus

#8
My understanding of the guidance in question is that FDA wants the testing process to fairly represent the production variability of a day's production.

So, if your testing is representative to that extent, they probably will accept your explanation.

If on the other hand it appears to them that your testing essentially was a "snapshot" of production, and there is no evidence that it was fully representative of production variability, they might not accept it.
1) Does that mean samples from multiple lots is better than from single lot from the FDA expectation perspective?
2) If FDA prefer samples from multiple lots then is there any guidance about how many lots are appropriate?
3) For example, I have samples from 3 lots (Lot#1, Lot#2, Lot#3), and I have 3 product properties (property#1, property#2,property#3) need to be verified via lab tests. How should I arrange the samples to have better representative of production variability? Which of the below protocol is the best?

Protocol 1:
property#1 (Lot#1, Lot#2, Lot#3)
property#2 (Lot#1, Lot#2, Lot#3)
property#3 (Lot#1, Lot#2, Lot#3)

Protocol 2:
property#1 (Lot#1, Lot#1, Lot#1)
property#2 (Lot#2, Lot#2, Lot#2)
property#3 (Lot#3, Lot#3, Lot#3)

Thanks
 
Thread starter Similar threads Forum Replies Date
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 14
M Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1
M Informational The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants a Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health – Final Rule Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Medical Device and FDA Regulations and Standards News 0
Ajit Basrur FDA Guidance Document - User Fees for 513(g) Requests US Food and Drug Administration (FDA) 3
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
J Electronic signatures FDA CFR 820 ISO 13485:2016 - Medical Device Quality Management Systems 3
C FDA logo for marketing US Food and Drug Administration (FDA) 3
G FDA clearance for a device that can't be used clinically (at present) Other US Medical Device Regulations 5
M FDA Syringe Marking requirements US Food and Drug Administration (FDA) 4
K Guidance on X-Ray Medical Devices for Animal Use - FDA US Food and Drug Administration (FDA) 0
S FDA 510(K) submission question US Food and Drug Administration (FDA) 4
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
I If i do not want to be an initial importer should i register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B When FDA Decision Summary opens? US Food and Drug Administration (FDA) 4
Ed Panek FDA Remote Regulatory Assessment (RRA) Overview 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
B How to submit Pre-submission to FDA? US Food and Drug Administration (FDA) 4
L FDA & 21 CFR Part 11 Medical Device and FDA Regulations and Standards News 19
B A.I. diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 6
Ed Panek 2020 FDA Top Ten Observations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M FDA Requirements for Investigational Devices - Clinical Investigation & Shipping Medical Device and FDA Regulations and Standards News 0
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B FDA Breakthrough Device can be overlapped with a designated device? US Food and Drug Administration (FDA) 6
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
Watchcat FDA vs NB Fees? Other US Medical Device Regulations 7
K FDA Registration and listing weird situation Medical Device and FDA Regulations and Standards News 4
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
E FDA 513(g) Cover Letter US Food and Drug Administration (FDA) 5
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 5

Similar threads

Top Bottom