Examples of Pre-Sub, SRD, PMA Shells and Templates

#1
Hi, I am new to this Forum: I am a Regulatory Affairs Associate, I work in CDx and IVDs, and I am interested in examples of pre-subs, SRDs, templates and or shells for PMAs, 510Ks.

Thanks in advance,

Alessandra
 
Elsmar Forum Sponsor
#3
For those of us following along:
pre-subs = pre-submissions?​
SDR = ?​
CDx = ?​
For SDR, I meant SRD, Study Risk Determination: is a request for FDA determination for whether a planned medical 136 device clinical study is significant risk (SR), non-significant risk (NSR), or exempt from IDE 137 regulations as defined by the IDE regulations (21 CFR part 812).

CDx: Companion Diagnostics
 
#4
For SDR, I meant SRD, Study Risk Determination: is a request for FDA determination for whether a planned medical 136 device clinical study is significant risk (SR), non-significant risk (NSR), or exempt from IDE 137 regulations as defined by the IDE regulations (21 CFR part 812).

CDx: Companion Diagnostics
Pre-sub: Presubmissions to FDA. A Pre-Sub includes a formal written request from an submitter for feedback from FDA that is provided in the form of a formal written response or, if the submitter6 chooses, formal written feedback followed by a meeting in which any additional feedback or clarifications are documented in meeting minutes.
 
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