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.
 
GAGEpack - Gage & Calibration Management
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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.
 
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