SBS - The Best Value in QMS software

Choice of FDA reviewer

primavesvera

Involved In Discussions
#1
I would like to start a discussion and to see what are your experiences regarding the FDA reviewers and their team.

For example, for the first device, we got a great reviewer, it was really easy working with him.

We did a few Q-Subs, also great cooperation.

However, recently we have been getting the same reviewer for a couple of products, and things are not going so great.

I wonder how they decide who will get the product for the review if they give it to the same reviewer because of the familiarity with the company or is there something else?

Your answers will be appreciated.

Cheers!
 
Elsmar Forum Sponsor

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#2
My experience is the FDA tries to keep the same reviewers with devices. Our current reviewer is very unresponsive but we take that as a good thing since our 60 day period for our 510(k) is coming up in a week.
 

primavesvera

Involved In Discussions
#3
My experience is the FDA tries to keep the same reviewers with devices. Our current reviewer is very unresponsive but we take that as a good thing since our 60 day period for our 510(k) is coming up in a week.
Ed, thanks for the response.

We were hoping for the same outcome, but then, a couple of days prior to the 90-days period, we got an additional information request. I hope it doesn't happen to you as well. :)
 

Watchcat

Trusted Information Resource
#4
Some reviewers are "better" than others. Some reviewers and companies are better fits than others. Plus, we are in the middle of a pandemic and FDA is in the middle of a political firestorm. It already advised industry it can't commit to MDUFA timelines. Your previous reviewer may have been overloaded at the time your submission came in. Do you know if they are still with the FDA? Still in the same position?
 

Watchcat

Trusted Information Resource
#5
My experience is the FDA tries to keep the same reviewers with devices.
Same devices yes, but my read is that this is not the same device, but other devices, same company. My experience is that you will often be assigned different reviewers for different devices. I think this is because reviewers are usually assigned to submissions, not to companies.
 

primavesvera

Involved In Discussions
#6
Some reviewers are "better" than others. Some reviewers and companies are better fits than others. Plus, we are in the middle of a pandemic and FDA is in the middle of a political firestorm. It already advised industry it can't commit to MDUFA timelines. Your previous reviewer may have been overloaded at the time your submission came in. Do you know if they are still with the FDA? Still in the same position?
Oh, the first encounter was in the pre-pandemic world. :)
It was for one product, software-based, but we continued to get the same reviewer, even if it's not the same product anymore (it's still a software, though).
 

mihzago

Trusted Information Resource
#7
I've had the same reviewer for the last 2 submissions but for one I recently sent have a new one, so it's hard to say who you'll get.

As others have said, FDA assigns based on availability, but possibly also to train reviewers on different devices. Attrition rates at the FDA are pretty high.
 
Thread starter Similar threads Forum Replies Date
Z Choice of PTC heater voltage to maximize user safety and ease of CE compliance to LVD CE Marking (Conformité Européene) / CB Scheme 0
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
J Supplier choice limitation - Many of them dont have PSCR, VDA or even ISO 9001 VDA Standards - Germany's Automotive Standards 0
V Making a choice of Simple vs Comprehensiveness of Procedure/System of any Process Document Control Systems, Procedures, Forms and Templates 4
N How to Stop Packaging Choice Mistakes on a Form Other Medical Device Related Standards 6
Wes Bucey Emerging industries and markets as a career choice Career and Occupation Discussions 5
M SPC software Measurlink7 - Good choice? Statistical Analysis Tools, Techniques and SPC 1
V Best value for choice/money - Smart phone vs tablet After Work and Weekend Discussion Topics 7
Sidney Vianna Do you scrutinize your supplier's choice of certification body (registrar)? Registrars and Notified Bodies 13
J Choice of Control Limits - Customer wants to control at 4.5 sigma Statistical Analysis Tools, Techniques and SPC 23
J Stores and Dispatch Training - Multiple choice questions Document Control Systems, Procedures, Forms and Templates 10
Stijloor Chrysler names Denso its first 'Supplier of Choice' World News 1
U Some MCQ (muitiple choice questions) QA questions.... Software Quality Assurance 1
C Graph Choice For Monitoring DOA's (Dead On Arrival) and ELF's (Early Life Failures) Statistical Analysis Tools, Techniques and SPC 5
Tim Folkerts DOE: Choosing a Design - Factors that affect the choice of design The Reading Room 0
C Everything Calibration Multiple Choice Test Questions General Measurement Device and Calibration Topics 2
E Is component engineering a good choice? Would age (in US) be a problem? Career and Occupation Discussions 0
N Vendor performance tracking - Software of choice? Quality Assurance and Compliance Software Tools and Solutions 5
A TS 16949 Clear Choice For Automotive Suppliers IATF 16949 - Automotive Quality Systems Standard 5
R TS 16949 becoming automotive standard of choice IATF 16949 - Automotive Quality Systems Standard 31
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) 5
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