Client lost copy of previous 513(g) submission package and responses

B

BKSmith

Registered
#1
#1
My newly engaged client has lost his copy of a 513(g) submission package (submission and full response, plus follow-up communication). The firm that represented him and submitted for him was acquired by another much larger firm, and it's unclear if the acquiring firm has this documentation package in its archives. Anyone have experience requesting / receiving from the agency a copy of the original submission, response, and follow-on communication? I'm hoping this is simple enough, and just not within my experience to-date.
Grateful for any advice.
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Watchcat

Watchcat

Trusted Information Resource
#2
#2
LOL And who says RA isn't fun?

I had a similar situation with a new employer, long, long ago. I would email Marjorie Shulman, long-time head of the submissions group. She's both competent and helpful. [email protected]

One issue might be whether the client can establish their "ownership" of the submission. (One of many reasons I'm opposed to consultants submitting on a client's behalf.) Another is whether her group gets all the follow-on communication, or only the official communications. But I'd start there. Then, once I got what I could get from her, I'd email someone involved in the review (e.g., the head of group that reviewed it, or perhaps there will be an obvious point of contact in the information you get from Marjorie), explain the situation and ask if they have any additional information that would not have gone to Marjorie's group for safekeeping, e.g., emails.

Please report back if you have a chance. Would be interested to know how CDRH deals with such situations these days.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Can the Registrar add an Observer without client approval? ISO 13485:2016 - Medical Device Quality Management Systems 4
J 9001 Internal Audit of Client Onboarding process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
T Client Communication - SaaMD company Misc. Quality Assurance and Business Systems Related Topics 3
S Moving from client-server to cloud-based, is that a new submission? Medical Information Technology, Medical Software and Health Informatics 3
J Medical Device Registration in Argentina - Client asks us to provide “European FSC” Other Medical Device Regulations World-Wide 4
S Client Audit Question - Entitled to see all of our documents in an audit? General Auditing Discussions 4
S Contract Packager or Repackager? And can client assume responsibility? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M Auditing processes followed by employees placed on client's site Internal Auditing 4
D Definition Client - How does the government define their clients? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
N Any comment, if a supplier raise an NCR to the Client? Oil and Gas Industry Standards and Regulations 5
Q Drawings from Client - ISO 9001:2008 Clause 4.2.3 or 7.5.4? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Best Method of Auditing an Installation Process at a client job-site ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Howard Atkins Rules 4th Edition Areas of Impact for Client Consideration IATF 16949 - Automotive Quality Systems Standard 1
Ajit Basrur Credit Suisse - Advertising Client Campaign Coffee Break and Water Cooler Discussions 1
C OHSAS 18001 and a site visit - All our work is on client sites Occupational Health & Safety Management Standards 4
N Client Request for Reference Equipment Calibration Certificate General Measurement Device and Calibration Topics 3
C ISO 13485 - Client Specific Validation and CE Marking CE Marking (Conformité Européene) / CB Scheme 3
L Client's Order Dock Inspection before Shipping Manufacturing and Related Processes 5
L ISO9001:2008 - Applicable clause for sending incompetent crew to client Service Industry Specific Topics 7
L Client that refuses to help - How to handle ? Misc. Quality Assurance and Business Systems Related Topics 5
I When the client seems to get involved in functions of our organization Quality Manager and Management Related Issues 6
S Should Client Controlled Procedures be Controlled Internally by us as well? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T Medical Device Software Verification & Validation for Client Specific Configurations Design and Development of Products and Processes 2
Q Managing Internal and Client Complaints ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Sales, different products/path to client, should be pictured each in Process Maps? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B QCP (Quality Control Plan) from client with EN 10204 type 3.1 Material Certificates Various Other Specifications, Standards, and related Requirements 2
C Client Order Data Error Tracking ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q How to Audit the Client Quality System - Product Failure caused by no Maintenance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Maintenance Schedule with Client in my Procedures? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Content and Details of a Client (Customer) Claim Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Client requires to witness an Internal Audit of our Sub-Contractor Internal Auditing 4
D How to implement Control of Employee Access to Client Data IEC 27001 - Information Security Management Systems (ISMS) 2
D Classification of Client (Customer) Complaints ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C CB Client Contract Agreement - Identifying nonconformances - AS9100 Registrars and Notified Bodies 7
I In ISO 9001:2008 - Can we show an Internal Department as our Client/Customer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
V ISO 9001 Consultant + Welding Inspector for Same Client - Conflict of interest? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Howard Atkins # Rules 3rd Edition Areas of Impact for Client Consideration IATF 16949 - Automotive Quality Systems Standard 1
L Client asking for us to perform VDA 275 - VDA questions VDA Standards - Germany's Automotive Standards 1
Sidney Vianna ANAB Accreditation Council Drafts Client Bill of Rights ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
F Document Control of client-specific instructions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
SteelMaiden Scrap Trader Kidnapped? UK scrap trader kidnapped by Chinese client World News 5
S Construction Projects - Client & contractor - System compatibility issues Quality Manager and Management Related Issues 4
M Service Level Agreement between Software Vendors and Client - Need help Urgently Software Quality Assurance 5
H Can the documents supplied by the client categorised as customer property?? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
CarolX Which BitTorrent Client do you use? After Work and Weekend Discussion Topics 18
D Can an unsatisfied client withhold the consultant's fee? Consultants and Consulting 14
A Net Promoter Score (NPS) for Analyzing the Client Satisfaction Misc. Quality Assurance and Business Systems Related Topics 3
J As a consultant, have you ever fired a client? If so, when? Consultants and Consulting 54
A Should I use "Client" or "Customer" in my documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24

Similar threads

Top Bottom