Product Intake & Class
Interactive Engine
ESTIMATED STATUTORY CLOCK
180 Days
MDUFA V Tier 1
Center Assignment & Milestones
Lead: CDRH
Jurisdiction Assignment (Office of Combination Products / OCP)
FD&C Act Sec. 503(g) determines Lead Jurisdiction from PMOA. Primary Center: CDRH. Consulting Center: CDER.
Lead: CDRH (ODE/OIR)
Formal Consult: CDER (OND)
21 CFR Part 3 Combination
Statutory Evidentiary Standard
Reasonable assurance of safety and effectiveness (FD&C Sec. 515) & cGMP biological sterility (Sec. 501).
Review Milestones & Inspection Gate
Day 45 Filing Review → Day 90 Inter-Center Consult & cGMP Quality System Inspection → Day 150 Panel Review → Day 180 MDUFA Action.
INTERACTIVE STATUTORY CLOCK SCRUBBER
Intake / IND-IDE
Filing / Inter-Center
Advisory Panel
Action Letter
Scrubber at Day 90: Inter-center CDRH/CDER cross-discipline audit underway; cGMP pre-approval manufacturing inspection orders dispatched.
STATUTORY BASIS
FD&C Sec. 515
USER FEE SCHEME
MDUFA V
ADVISORY MANDATE
GHP Panel
Statutory & Discretion Matrix
21 U.S.C. § 301
| Regulatory Dimension | Tier / Standard | Legal Scope |
|---|---|---|
| Premarket Review | PMA (Class III) | Statutory |
| Evidence Burden | Reasonable Assurance S&E | 21 USC 360e |
| Leadership Discretion | Advisory Convocation / RWE | Discretionary |
| Post-Market Authority | Sec. 522 Surveillance Order | Administrative |
Generating dossier payload...
Grounding: FDA Modernization Act, 21 CFR Parts 3, 314, 601, 814, 860; FD&C Act §§ 503(g), 505, 510(k), 513, 515; PHS Act § 351.