Correct pathway type

Correct 510(k) sub-type

SE comparison required

Required section coverage

Software documentation standard

RTA: user fee

RTA: Form 3514

RTA: predicate K-number

eSTAR submission portal

Q-Sub recommendation

Q-Sub question format

Timeline and fee cited

BA classification

PHI identification

Risk assessment: 7-step structure

Unique user IDs required

Transmission encryption spec

At-rest encryption spec

Audit log retention

BAA required provisions

Breach notification timing

HHS notification threshold

Breach 4-factor test

MFA recommendation

Tier 1 classification

STRIDE methodology used

CycloneDX SBOM format

SBOM NTIA elements

CVD acknowledgment timeline

CVD initial assessment timeline

CVSS Critical response time

NVD/ICS-CERT monitoring

AES-256 at rest

TLS 1.2+ in transit

Defense-in-depth

CVD status updates

Class II applicability

6-step workflow sequence

Design Input criteria

Design Output traceability

Independent reviewer requirement

Verification vs Validation distinction

DHF contents

Design Transfer prerequisites

Gap identification accuracy

Validation phase requirement

QSR section reference

Mandatory CAPA trigger: NCR recurrence

Mandatory CAPA trigger: safety complaint

Correction vs CAPA distinction

7-step CAPA sequence

Root cause tool used

Root cause specificity

Effectiveness monitoring period

Effectiveness criteria specificity

Management approval for closure

On-time closure metric target

Effectiveness rate metric target

Average closure time metric target

820.100 reference

De Novo pathway selected

No predicate justification

Low-to-moderate risk eligibility

PMA comparison: high risk only

De Novo timeline cited

De Novo cost cited

Risk analysis: hazard categories

Risk analysis structure

Benefit-risk analysis

Special controls specificity

Class II outcome

Creates predicate for future 510(k)s

General controls adequacy statement