Reducing 510(k) Rework White Paper | i-GENTIC AI

Reducing 510(k) Rework Through Evidence-Linked Predicate Selection

Predicate selection and substantial equivalence are closely coupled in practice. When indications, claims, and evidence are aligned early, review cycles become more predictable and the rationale is easier to defend.

Regulatory teams add the most value when their time is spent on technical and clinical judgment. Internal contradictions consume that time and introduce avoidable delay.

Pilot Study

Pilot Measurement Snapshot

Purpose: Evaluate process and quality effects associated with improved predicate discipline and internal consistency checks.

Metric	Baseline	Pilot	Change
Kickoff to FDA clearance (months)	6.8	4.4	2.4 mo
Indications vs claims mismatches (index)	100	21	79%

Kickoff to FDA clearance (months)

Baseline 6.8

Pilot 4.4

Change ↓2.4

Indications vs claims mismatches (index)

Baseline 100

Pilot 21

Change ↓79%

Reducing 510(k) Rework Through Evidence-Linked Predicate Selection

Pilot Measurement Snapshot

Baseline

6.8

months

Average

clearance timeline

Pilot Program

4.4

months

Improved

clearance timeline

Baseline (Before)

100

(Indications vs claims mismatches index)

Pilot (After)

21

(Indications vs claims mismatches index)

Improvement

79%

reduction