REGULATORY WATCHCAT De novo Post Mortem 2 - Disclosure and Accountability

Watchcat

Watchcat

Trusted Information Resource
#1
#1
860.5(g)(1) The existence of a De Novo request may not be disclosed by FDA before an order granting the De Novo request is issued, unless it previously has been publicly disclosed or acknowledged by the De Novo requester.

For years I’ve tried to come up with a reason for this, other than to spare CDRH from being transparently accountable for each and every submission it receives. I haven’t been able to come up with one, but I’m still open to the possibility. It seems clear to me that CDRH is not going to endanger confidential or proprietary information (or “national security”) by disclosing the mere existence of a De novo request, e.g., by posting a DEN number and date received. The same is true when it comes to posting the date it was accepted for review or the date it was refused or declined or whatever. This is accountability in its most basic form; why not do it?

Continued in attachment...
 

Attachments

SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Watchcat

Watchcat

Trusted Information Resource
#3
#3
Well, that's half of it, and, IMO, the reasonable half.

CDRH is always going to serve it's own interests. It's the nature of organizations. A colleague emailed me yesterday to make just that point. I said I was fine with that. I’m not so fine with lame rationales. But mostly I’m not fine with no one on the industry side demanding transparency and accountability. I mean really demanding, not just humming the tune. They have a few lobbyists, you know. Why would CDRH do it if industry accepts it not doing it? That wouldn't even be smart, IMO.

Of course, there is the possibility that industry really thinks some harm will come to it if CDRH posts DEN number and date of receipt. But I doubt it. Some of its ramora, maybe. Speaking of a few lobbyists, there are no few that seem to come up with things to "push back" about, just so they can tell industry they are pushing back, but have no idea what actually serves industry well.

I now don't know why they even bother with the MDUFA negotiations. Perhaps sort of a broad sword mentality, that if they don't at least negotiate, then CDRH will set user fees sky high and its commitments a year or more out. But not serious enough about it to really want accountability on the commitments.
 
Ed Panek

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#4
#4
Doesn't FDA have to prepare to Congress presentations on what it is doing with taxpayers' monies? I think with COVID they were not able to say "nothing" in terms of audits for very long; hence the remote assessments that are taking place.
 
Watchcat

Watchcat

Trusted Information Resource
#5
#5
Ed Panek said:
Doesn't FDA have to prepare to Congress presentations on what it is doing with taxpayers' monies?
Click to expand...
Yes, and it is periodically audited by the GAO. But the MDUFA fees are not taxpayers' monies. And, under my scenarios, it's not like CDRH is doing anything untoward with money, so nothing to pick up on there. If it has done the work it says it did (which I would expect is the case), and just fidgets with the dates, I don't see how that is of any interest to anyone but industry.
 
Ed Panek

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#6
#6
On a bit of a different thread, how are the 510(k) third-party reviewers performing to your knowledge?
 
Watchcat

Watchcat

Trusted Information Resource
#7
#7
Very recently, I saw that FDA had decertified one for fraud. :( Not sure which one.

I don't have any recent information on the performance of the rest, but I've thought that they might be a bit more appealing now, given FDA's extra workload.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 6 – How Does This Even Happen? Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 5 – What's the Rush? Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 4 – Design Controls Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 3 - Rearranging the Regs Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT De novo Post Mortem 1 - Regulatory Religion Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT De novo Post Mortem Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Samples & Labeling Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Clinical Investigations Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Nonclinical Studies Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Benefits and Risks Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Special Controls and Standards Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Alternative Practices and Procedures Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Device Description Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Indications for Use Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - General Comments Other US Medical Device Regulations 2
Watchcat REGULATORY WATCHCAT - De novo info updated and consolidated Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - New RA Cartoon Other US Medical Device Regulations 4
Watchcat REGULATORY WATCHCAT - RIP "Mini-PMA" Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - His Grandmother's Technology Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - The 510(k) Submissions Tracker Other US Medical Device Regulations 0
Watchcat Year of the Regulatory Watchcat Other US Medical Device Regulations 6
C MSc Dissertation Survey - Regulatory Approval Medical Device and FDA Regulations and Standards News 0
V Regulatory consultants for US FDA ANDA - pharma / drug products Consultants and Consulting 0
V Countries without Formal Regulatory Approval Process Other Medical Device Regulations World-Wide 0
P Crucial Suppliers Listed on Regulatory Certificates EU Medical Device Regulations 3
N Brexit Combination Product Regulatory pathway for UK (MHRA). UK Medical Device Regulations 1
MaHoDie Regulatory compliance for IVD in india Other Medical Device Regulations World-Wide 2
A New to QMS and regulatory... advice on training/certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
A Class 2a CE Mark Regulatory Pathway CE Marking (Conformité Européene) / CB Scheme 1
C Regulatory requirements of cloud platform for devices developed in compliance with 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
A CE-Mark regulatory advice - US based Organization CE Marking (Conformité Européene) / CB Scheme 6
J Regulatory path to enter EU market for non medical 60601 component Other Medical Device Regulations World-Wide 2
Justanobody PAD printing and meeting regulatory requirements Manufacturing and Related Processes 10
A Metadata For Drugs, API's, Regulatory & Clinical Documents and Dossier Service Industry Specific Topics 2
S Training for PRRC (person responsible for regulatory compliance) EU Medical Device Regulations 3
V Software license key regulatory requirements Medical Information Technology, Medical Software and Health Informatics 2
H Medical Devices Regulatory Intelligence for International Markets ISO 13485:2016 - Medical Device Quality Management Systems 1
D IS0 13485 - Design perspective to regulatory requirement. ISO 13485:2016 - Medical Device Quality Management Systems 3
T Logistics and 3PL regulatory requirement in India for Pharmaceuticals and Med devices Other Medical Device Regulations World-Wide 0
C Regulatory Affairs in a start-up medical device company Career and Occupation Discussions 1
P Exclusion of clause 8.2.3 Reporting to regulatory authorities ISO 13485:2016 - Medical Device Quality Management Systems 7
A Readiness for consultancy in Regulatory Affairs Consultants and Consulting 5
A A good Regulatory Affairs Manager EU Medical Device Regulations 15
M Regulatory compliance ISO 14001 ISO 14001:2015 Specific Discussions 5
E Which regulatory framework for an app-based study for research purposes? EU Medical Device Regulations 1
JoCam FSN for regulatory breach EU Medical Device Regulations 4
M Regulatory Change assessment US Food and Drug Administration (FDA) 3
P Transferring medical data from a device (Sec 201(h)): regulatory implications US Medical Device Regulations 3
D Regulatory Affairs Certification (RAC) Devices Exam - Autumn 2022 study Professional Certifications and Degrees 3
K Regulatory Aspect of Embedding 4G/5G communication technologies into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2

Similar threads

Top Bottom