REGULATORY WATCHCAT De Novo Post-Mortem 6 – How Does This Even Happen?

Watchcat

Trusted Information Resource
#1
To be clear, I don’t mean to criticize whoever it was that drafted the definitions for the Proposed Rule and/or responded to my comment. Well…except for apparently not having compared my comment to the section of Proposed Rule that I was commenting on, which should have at least clued them into the fact that I wasn’t suggesting keeping anything, but adding something. And seems to me like an obvious thing for them to have done.

What astonishes me is that someone who didn’t have strong writing skills and was generally unfamiliar with CDRH’s regulations was assigned to work on these tasks, apparently without any meangingful oversight of the end result. This was, after all, a Proposed Rule, one step below the Act itself. Really, one step below FDA being Congress. It was also the definitions, which are the foundation for understanding the entire Rule.

I can’t help but wonder if this reflects a conclusion on CDRH’s part, that the De novo pathway has been largely a bust, and therefore it was not worth investing the appropriate resources in the Proposed and Final Rule.

My full comment, CDRH’s response, and my full comments on its response, are attached.


The Regulatory Watchcat
 

Attachments

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
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 2 - Disclosure and Accountability Other US Medical Device Regulations 11
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
N Brexit Combination Product Regulatory pathway for UK (MHRA). UK Medical Device Regulations 0
MaHoDie Regulatory compliance for IVD in india Other Medical Device Regulations World-Wide 0
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
Watchcat Does Regulatory Affairs put the "no" in innovation? Other US Medical Device Regulations 14
Q ISO 20417:2021- Regulatory Identification Other ISO and International Standards and European Regulations 3
Ed Panek FDA Remote Regulatory Assessment (RRA) Overview 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
P Quality and Regulatory organizational structure Consultants and Consulting 2

Similar threads

Top Bottom