Regulatory Affairs Head

#!/usr/bin/env python3
"""
Regulatory Pathway Analyzer - Determines optimal regulatory pathway for medical devices.

Analyzes device characteristics and recommends the most efficient regulatory pathway
across multiple markets (FDA, EU MDR, UK UKCA, Health Canada, TGA, PMDA).

Supports:
- FDA: 510(k), De Novo, PMA, Breakthrough Device
- EU MDR: Class I, IIa, IIb, III, AIMDD
- UK: UKCA marking
- Health Canada: Class I-IV
- TGA: Class I, IIa, IIb, III
- Japan PMDA: Class I-IV

Usage:
    python regulatory_pathway_analyzer.py --device-class II --predicate yes --market all
    python regulatory_pathway_analyzer.py --interactive
    python regulatory_pathway_analyzer.py --data device_profile.json --output json
"""

import argparse
import json
import sys
from dataclasses import dataclass, field, asdict
from typing import List, Dict, Optional, Tuple
from enum import Enum


class RiskClass(Enum):
    CLASS_I = "I"
    CLASS_IIA = "IIa"
    CLASS_IIB = "IIb"
    CLASS_III = "III"
    CLASS_IV = "IV"


class MarketRegion(Enum):
    US_FDA = "US-FDA"
    EU_MDR = "EU-MDR"
    UK_UKCA = "UK-UKCA"
    HEALTH_CANADA = "Health-Canada"
    AUSTRALIA_TGA = "Australia-TGA"
    JAPAN_PMDA = "Japan-PMDA"


@dataclass
class DeviceProfile:
    """Medical device profile for pathway analysis."""
    device_name: str
    intended_use: str
    device_class: str  # I, IIa, IIb, III
    novel_technology: bool = False
    predicate_available: bool = True
    implantable: bool = False
    life_sustaining: bool = False
    software_component: bool = False
    ai_ml_component: bool = False
    sterile: bool = False
    measuring_function: bool = False
    target_markets: List[str] = field(default_factory=lambda: ["US-FDA", "EU-MDR"])


@dataclass
class PathwayOption:
    """A regulatory pathway option."""
    pathway_name: str
    market: str
    estimated_timeline_months: Tuple[int, int]
    estimated_cost_usd: Tuple[int, int]
    key_requirements: List[str]
    advantages: List[str]
    risks: List[str]
    recommendation_level: str  # "Recommended", "Alternative", "Not Recommended"


@dataclass
class PathwayAnalysis:
    """Complete pathway analysis result."""
    device: DeviceProfile
    recommended_pathways: List[PathwayOption]
    optimal_sequence: List[str]  # Recommended submission order
    total_timeline_months: Tuple[int, int]
    total_estimated_cost: Tuple[int, int]
    critical_success_factors: List[str]
    warnings: List[str]


class RegulatoryPathwayAnalyzer:
    """Analyzes and recommends regulatory pathways for medical devices."""

    # FDA pathway decision matrix
    FDA_PATHWAYS = {
        "I": {
            "pathway": "510(k) Exempt / Registration & Listing",
            "timeline": (1, 3),
            "cost": (5000, 15000),
            "requirements": ["Establishment registration", "Device listing", "GMP compliance (if non-exempt)"]
        },
        "II": {
            "pathway": "510(k)",
            "timeline": (6, 12),
            "cost": (50000, 250000),
            "requirements": ["Predicate device identification", "Substantial equivalence demonstration", "Performance testing", "Biocompatibility (if applicable)", "Software documentation (if applicable)"]
        },
        "II-novel": {
            "pathway": "De Novo",
            "timeline": (12, 18),
            "cost": (150000, 400000),
            "requirements": ["Risk-based classification request", "Special controls development", "Performance testing", "Clinical data (potentially)"]
        },
        "III": {
            "pathway": "PMA",
            "timeline": (18, 36),
            "cost": (500000, 2000000),
            "requirements": ["Clinical investigations", "Manufacturing information", "Performance testing", "Risk-benefit analysis", "Post-approval studies"]
        },
        "III-breakthrough": {
            "pathway": "Breakthrough Device Program + PMA",
            "timeline": (12, 24),
            "cost": (500000, 2000000),
            "requirements": ["Breakthrough designation request", "More flexible clinical evidence", "Iterative FDA engagement", "Post-market data collection"]
        }
    }

    # EU MDR pathway decision matrix
    EU_MDR_PATHWAYS = {
        "I": {
            "pathway": "Self-declaration (Class I)",
            "timeline": (2, 4),
            "cost": (10000, 30000),
            "requirements": ["Technical documentation", "EU Declaration of Conformity", "UDI assignment", "EUDAMED registration", "Authorized Representative (if non-EU)"]
        },
        "IIa": {
            "pathway": "Notified Body assessment (Class IIa)",
            "timeline": (12, 18),
            "cost": (80000, 200000),
            "requirements": ["QMS certification (ISO 13485)", "Technical documentation", "Clinical evaluation", "Notified Body audit", "Post-market surveillance plan"]
        },
        "IIb": {
            "pathway": "Notified Body assessment (Class IIb)",
            "timeline": (15, 24),
            "cost": (150000, 400000),
            "requirements": ["Full QMS certification", "Comprehensive technical documentation", "Clinical evaluation (may need clinical investigation)", "Type examination or product verification", "Notified Body scrutiny"]
        },
        "III": {
            "pathway": "Notified Body assessment (Class III)",
            "timeline": (18, 30),
            "cost": (300000, 800000),
            "requirements": ["Full QMS certification", "Complete technical documentation", "Clinical investigation (typically required)", "Notified Body clinical evaluation review", "Scrutiny procedure (possible)", "PMCF plan"]
        }
    }

    def __init__(self):
        self.analysis_warnings = []

    def analyze_fda_pathway(self, device: DeviceProfile) -> PathwayOption:
        """Determine optimal FDA pathway."""
        device_class = device.device_class.upper().replace("IIA", "II").replace("IIB", "II")

        if device_class == "I":
            pathway_data = self.FDA_PATHWAYS["I"]
            return PathwayOption(
                pathway_name=pathway_data["pathway"],
                market="US-FDA",
                estimated_timeline_months=pathway_data["timeline"],
                estimated_cost_usd=pathway_data["cost"],
                key_requirements=pathway_data["requirements"],
                advantages=["Fastest path to market", "Minimal regulatory burden", "No premarket submission required (if exempt)"],
                risks=["Limited to exempt product codes", "Still requires GMP compliance"],
                recommendation_level="Recommended"
            )

        elif device_class == "III" or device.implantable or device.life_sustaining:
            if device.novel_technology:
                pathway_data = self.FDA_PATHWAYS["III-breakthrough"]
                rec_level = "Recommended" if device.novel_technology else "Alternative"
            else:
                pathway_data = self.FDA_PATHWAYS["III"]
                rec_level = "Recommended"
        else:  # Class II
            if device.predicate_available and not device.novel_technology:
                pathway_data = self.FDA_PATHWAYS["II"]
                rec_level = "Recommended"
            else:
                pathway_data = self.FDA_PATHWAYS["II-novel"]
                rec_level = "Recommended"

        return PathwayOption(
            pathway_name=pathway_data["pathway"],
            market="US-FDA",
            estimated_timeline_months=pathway_data["timeline"],
            estimated_cost_usd=pathway_data["cost"],
            key_requirements=pathway_data["requirements"],
            advantages=self._get_fda_advantages(pathway_data["pathway"], device),
            risks=self._get_fda_risks(pathway_data["pathway"], device),
            recommendation_level=rec_level
        )

    def analyze_eu_mdr_pathway(self, device: DeviceProfile) -> PathwayOption:
        """Determine optimal EU MDR pathway."""
        device_class = device.device_class.lower().replace("iia", "IIa").replace("iib", "IIb")

        if device_class in ["i", "1"]:
            pathway_data = self.EU_MDR_PATHWAYS["I"]
            class_key = "I"
        elif device_class in ["iia", "2a"]:
            pathway_data = self.EU_MDR_PATHWAYS["IIa"]
            class_key = "IIa"
        elif device_class in ["iib", "2b"]:
            pathway_data = self.EU_MDR_PATHWAYS["IIb"]
            class_key = "IIb"
        else:
            pathway_data = self.EU_MDR_PATHWAYS["III"]
            class_key = "III"

        # Adjust for implantables
        if device.implantable and class_key in ["IIa", "IIb"]:
            pathway_data = self.EU_MDR_PATHWAYS["III"]
            self.analysis_warnings.append(
                f"Implantable devices are typically upclassified to Class III under EU MDR"
            )

        return PathwayOption(
            pathway_name=pathway_data["pathway"],
            market="EU-MDR",
            estimated_timeline_months=pathway_data["timeline"],
            estimated_cost_usd=pathway_data["cost"],
            key_requirements=pathway_data["requirements"],
            advantages=self._get_eu_advantages(pathway_data["pathway"], device),
            risks=self._get_eu_risks(pathway_data["pathway"], device),
            recommendation_level="Recommended"
        )

    def _get_fda_advantages(self, pathway: str, device: DeviceProfile) -> List[str]:
        advantages = []
        if "510(k)" in pathway:
            advantages.extend([
                "Well-established pathway with clear guidance",
                "Predictable review timeline",
                "Lower clinical evidence requirements vs PMA"
            ])
            if device.predicate_available:
                advantages.append("Predicate device identified - streamlined review")
        elif "De Novo" in pathway:
            advantages.extend([
                "Creates new predicate for future 510(k) submissions",
                "Appropriate for novel low-moderate risk devices",
                "Can result in Class I or II classification"
            ])
        elif "PMA" in pathway:
            advantages.extend([
                "Strongest FDA approval - highest market credibility",
                "Difficult for competitors to challenge",
                "May qualify for breakthrough device benefits"
            ])
        elif "Breakthrough" in pathway:
            advantages.extend([
                "Priority review and interactive FDA engagement",
                "Flexible clinical evidence requirements",
                "Faster iterative development with FDA feedback"
            ])
        return advantages

    def _get_fda_risks(self, pathway: str, device: DeviceProfile) -> List[str]:
        risks = []
        if "510(k)" in pathway:
            risks.extend([
                "Predicate device may be challenged",
                "SE determination can be subjective"
            ])
            if device.software_component:
                risks.append("Software documentation requirements increasing (Cybersecurity, AI/ML)")
        elif "De Novo" in pathway:
            risks.extend([
                "Less predictable than 510(k)",
                "May require more clinical data than expected",
                "New special controls may be imposed"
            ])
        elif "PMA" in pathway:
            risks.extend([
                "Very expensive and time-consuming",
                "Clinical trial risks and delays",
                "Post-approval study requirements"
            ])
        if device.ai_ml_component:
            risks.append("AI/ML components face evolving regulatory requirements")
        return risks

    def _get_eu_advantages(self, pathway: str, device: DeviceProfile) -> List[str]:
        advantages = ["Access to entire EU/EEA market (27+ countries)"]
        if "Self-declaration" in pathway:
            advantages.extend([
                "No Notified Body involvement required",
                "Fastest path to EU market",
                "Lowest cost option"
            ])
        elif "IIa" in pathway:
            advantages.append("Moderate regulatory burden with broad market access")
        elif "IIb" in pathway or "III" in pathway:
            advantages.extend([
                "Strong market credibility with NB certification",
                "Recognized globally for regulatory quality"
            ])
        return advantages

    def _get_eu_risks(self, pathway: str, device: DeviceProfile) -> List[str]:
        risks = []
        if "Self-declaration" not in pathway:
            risks.extend([
                "Limited Notified Body capacity - long wait times",
                "Notified Body costs increasing under MDR"
            ])
        risks.append("MDR transition still creating uncertainty")
        if device.software_component:
            risks.append("EU AI Act may apply to AI/ML medical devices")
        return risks

    def determine_optimal_sequence(self, pathways: List[PathwayOption], device: DeviceProfile) -> List[str]:
        """Determine optimal submission sequence across markets."""
        # General principle: Start with fastest/cheapest, use data for subsequent submissions
        sequence = []

        # Sort by timeline (fastest first)
        sorted_pathways = sorted(pathways, key=lambda p: p.estimated_timeline_months[0])

        # FDA first if 510(k) - well recognized globally
        fda_pathway = next((p for p in pathways if p.market == "US-FDA"), None)
        eu_pathway = next((p for p in pathways if p.market == "EU-MDR"), None)

        if fda_pathway and "510(k)" in fda_pathway.pathway_name:
            sequence.append("1. US-FDA 510(k) first - clearance recognized globally, data reusable")
            if eu_pathway:
                sequence.append("2. EU-MDR - use FDA data in clinical evaluation")
        elif eu_pathway and "Self-declaration" in eu_pathway.pathway_name:
            sequence.append("1. EU-MDR (Class I self-declaration) - fastest market entry")
            if fda_pathway:
                sequence.append("2. US-FDA - use EU experience and data")
        else:
            for i, p in enumerate(sorted_pathways, 1):
                sequence.append(f"{i}. {p.market} ({p.pathway_name})")

        return sequence

    def analyze(self, device: DeviceProfile) -> PathwayAnalysis:
        """Perform complete pathway analysis."""
        self.analysis_warnings = []
        pathways = []

        for market in device.target_markets:
            if "FDA" in market or "US" in market:
                pathways.append(self.analyze_fda_pathway(device))
            elif "MDR" in market or "EU" in market:
                pathways.append(self.analyze_eu_mdr_pathway(device))
            # Additional markets can be added here

        sequence = self.determine_optimal_sequence(pathways, device)

        total_timeline_min = sum(p.estimated_timeline_months[0] for p in pathways)
        total_timeline_max = sum(p.estimated_timeline_months[1] for p in pathways)
        total_cost_min = sum(p.estimated_cost_usd[0] for p in pathways)
        total_cost_max = sum(p.estimated_cost_usd[1] for p in pathways)

        csf = [
            "Early engagement with regulators (Pre-Sub/Scientific Advice)",
            "Robust QMS (ISO 13485) in place before submissions",
            "Clinical evidence strategy aligned with target markets",
            "Cybersecurity and software documentation (if applicable)"
        ]

        if device.ai_ml_component:
            csf.append("AI/ML transparency and bias documentation")

        return PathwayAnalysis(
            device=device,
            recommended_pathways=pathways,
            optimal_sequence=sequence,
            total_timeline_months=(total_timeline_min, total_timeline_max),
            total_estimated_cost=(total_cost_min, total_cost_max),
            critical_success_factors=csf,
            warnings=self.analysis_warnings
        )


def format_analysis_text(analysis: PathwayAnalysis) -> str:
    """Format analysis as readable text report."""
    lines = [
        "=" * 70,
        "REGULATORY PATHWAY ANALYSIS REPORT",
        "=" * 70,
        f"Device: {analysis.device.device_name}",
        f"Intended Use: {analysis.device.intended_use}",
        f"Device Class: {analysis.device.device_class}",
        f"Target Markets: {', '.join(analysis.device.target_markets)}",
        "",
        "DEVICE CHARACTERISTICS",
        "-" * 40,
        f"  Novel Technology: {'Yes' if analysis.device.novel_technology else 'No'}",
        f"  Predicate Available: {'Yes' if analysis.device.predicate_available else 'No'}",
        f"  Implantable: {'Yes' if analysis.device.implantable else 'No'}",
        f"  Life-Sustaining: {'Yes' if analysis.device.life_sustaining else 'No'}",
        f"  Software/AI Component: {'Yes' if analysis.device.software_component or analysis.device.ai_ml_component else 'No'}",
        f"  Sterile: {'Yes' if analysis.device.sterile else 'No'}",
        "",
        "RECOMMENDED PATHWAYS",
        "-" * 40,
    ]

    for pathway in analysis.recommended_pathways:
        lines.extend([
            "",
            f"  [{pathway.market}] {pathway.pathway_name}",
            f"  Recommendation: {pathway.recommendation_level}",
            f"  Timeline: {pathway.estimated_timeline_months[0]}-{pathway.estimated_timeline_months[1]} months",
            f"  Estimated Cost: ${pathway.estimated_cost_usd[0]:,} - ${pathway.estimated_cost_usd[1]:,}",
            f"  Key Requirements:",
        ])
        for req in pathway.key_requirements:
            lines.append(f"    • {req}")
        lines.append(f"  Advantages:")
        for adv in pathway.advantages:
            lines.append(f"    + {adv}")
        lines.append(f"  Risks:")
        for risk in pathway.risks:
            lines.append(f"    ! {risk}")

    lines.extend([
        "",
        "OPTIMAL SUBMISSION SEQUENCE",
        "-" * 40,
    ])
    for step in analysis.optimal_sequence:
        lines.append(f"  {step}")

    lines.extend([
        "",
        "TOTAL ESTIMATES",
        "-" * 40,
        f"  Combined Timeline: {analysis.total_timeline_months[0]}-{analysis.total_timeline_months[1]} months",
        f"  Combined Cost: ${analysis.total_estimated_cost[0]:,} - ${analysis.total_estimated_cost[1]:,}",
        "",
        "CRITICAL SUCCESS FACTORS",
        "-" * 40,
    ])
    for i, factor in enumerate(analysis.critical_success_factors, 1):
        lines.append(f"  {i}. {factor}")

    if analysis.warnings:
        lines.extend([
            "",
            "WARNINGS",
            "-" * 40,
        ])
        for warning in analysis.warnings:
            lines.append(f"  ⚠ {warning}")

    lines.append("=" * 70)
    return "\n".join(lines)


def interactive_mode():
    """Interactive device profiling."""
    print("=" * 60)
    print("Regulatory Pathway Analyzer - Interactive Mode")
    print("=" * 60)

    device = DeviceProfile(
        device_name=input("\nDevice Name: ").strip(),
        intended_use=input("Intended Use: ").strip(),
        device_class=input("Device Class (I/IIa/IIb/III): ").strip(),
        novel_technology=input("Novel technology? (y/n): ").strip().lower() == 'y',
        predicate_available=input("Predicate device available? (y/n): ").strip().lower() == 'y',
        implantable=input("Implantable? (y/n): ").strip().lower() == 'y',
        life_sustaining=input("Life-sustaining? (y/n): ").strip().lower() == 'y',
        software_component=input("Software component? (y/n): ").strip().lower() == 'y',
        ai_ml_component=input("AI/ML component? (y/n): ").strip().lower() == 'y',
    )

    markets = input("Target markets (comma-separated, e.g., US-FDA,EU-MDR): ").strip()
    if markets:
        device.target_markets = [m.strip() for m in markets.split(",")]

    analyzer = RegulatoryPathwayAnalyzer()
    analysis = analyzer.analyze(device)
    print("\n" + format_analysis_text(analysis))


def main():
    parser = argparse.ArgumentParser(description="Regulatory Pathway Analyzer for Medical Devices")
    parser.add_argument("--device-name", type=str, help="Device name")
    parser.add_argument("--device-class", type=str, choices=["I", "IIa", "IIb", "III"], help="Device classification")
    parser.add_argument("--predicate", type=str, choices=["yes", "no"], help="Predicate device available")
    parser.add_argument("--novel", action="store_true", help="Novel technology")
    parser.add_argument("--implantable", action="store_true", help="Implantable device")
    parser.add_argument("--software", action="store_true", help="Software component")
    parser.add_argument("--ai-ml", action="store_true", help="AI/ML component")
    parser.add_argument("--market", type=str, default="all", help="Target market(s)")
    parser.add_argument("--data", type=str, help="JSON file with device profile")
    parser.add_argument("--output", choices=["text", "json"], default="text", help="Output format")
    parser.add_argument("--interactive", action="store_true", help="Interactive mode")

    args = parser.parse_args()

    if args.interactive:
        interactive_mode()
        return

    if args.data:
        with open(args.data) as f:
            data = json.load(f)
        device = DeviceProfile(**data)
    elif args.device_class:
        device = DeviceProfile(
            device_name=args.device_name or "Unnamed Device",
            intended_use="Medical device",
            device_class=args.device_class,
            novel_technology=args.novel,
            predicate_available=args.predicate == "yes" if args.predicate else True,
            implantable=args.implantable,
            software_component=args.software,
            ai_ml_component=args.ai_ml,
        )
        if args.market != "all":
            device.target_markets = [m.strip() for m in args.market.split(",")]
    else:
        # Demo mode
        device = DeviceProfile(
            device_name="SmartGlucose Monitor Pro",
            intended_use="Continuous glucose monitoring for diabetes management",
            device_class="II",
            novel_technology=False,
            predicate_available=True,
            software_component=True,
            ai_ml_component=True,
            target_markets=["US-FDA", "EU-MDR"]
        )

    analyzer = RegulatoryPathwayAnalyzer()
    analysis = analyzer.analyze(device)

    if args.output == "json":
        result = {
            "device": asdict(analysis.device),
            "pathways": [asdict(p) for p in analysis.recommended_pathways],
            "optimal_sequence": analysis.optimal_sequence,
            "total_timeline_months": list(analysis.total_timeline_months),
            "total_estimated_cost": list(analysis.total_estimated_cost),
            "critical_success_factors": analysis.critical_success_factors,
            "warnings": analysis.warnings
        }
        print(json.dumps(result, indent=2))
    else:
        print(format_analysis_text(analysis))


if __name__ == "__main__":
    main()

#!/usr/bin/env python3
"""
Regulatory Submission Tracking System
Automates monitoring and reporting of regulatory submission status
"""

import json
import datetime
from typing import Dict, List, Optional
from dataclasses import dataclass, asdict
from enum import Enum

class SubmissionType(Enum):
    FDA_510K = "FDA_510K"
    FDA_PMA = "FDA_PMA"
    FDA_DE_NOVO = "FDA_DE_NOVO"
    EU_MDR_CE = "EU_MDR_CE"
    ISO_CERTIFICATION = "ISO_CERTIFICATION"
    GLOBAL_REGULATORY = "GLOBAL_REGULATORY"

class SubmissionStatus(Enum):
    PLANNING = "PLANNING"
    IN_PREPARATION = "IN_PREPARATION"
    SUBMITTED = "SUBMITTED"
    UNDER_REVIEW = "UNDER_REVIEW"
    ADDITIONAL_INFO_REQUESTED = "ADDITIONAL_INFO_REQUESTED"
    APPROVED = "APPROVED"
    REJECTED = "REJECTED"
    WITHDRAWN = "WITHDRAWN"

@dataclass
class RegulatorySubmission:
    submission_id: str
    product_name: str
    submission_type: SubmissionType
    submission_status: SubmissionStatus
    target_market: str
    submission_date: Optional[datetime.date] = None
    target_approval_date: Optional[datetime.date] = None
    actual_approval_date: Optional[datetime.date] = None
    regulatory_authority: str = ""
    responsible_person: str = ""
    notes: str = ""
    last_updated: datetime.date = datetime.date.today()

class RegulatoryTracker:
    def __init__(self, data_file: str = "regulatory_submissions.json"):
        self.data_file = data_file
        self.submissions: Dict[str, RegulatorySubmission] = {}
        self.load_data()
    
    def load_data(self):
        """Load existing submission data from JSON file"""
        try:
            with open(self.data_file, 'r') as f:
                data = json.load(f)
                for sub_id, sub_data in data.items():
                    # Convert date strings back to date objects
                    for date_field in ['submission_date', 'target_approval_date', 
                                     'actual_approval_date', 'last_updated']:
                        if sub_data.get(date_field):
                            sub_data[date_field] = datetime.datetime.strptime(
                                sub_data[date_field], '%Y-%m-%d').date()
                    
                    # Convert enums
                    sub_data['submission_type'] = SubmissionType(sub_data['submission_type'])
                    sub_data['submission_status'] = SubmissionStatus(sub_data['submission_status'])
                    
                    self.submissions[sub_id] = RegulatorySubmission(**sub_data)
        except FileNotFoundError:
            print(f"No existing data file found. Starting fresh.")
        except Exception as e:
            print(f"Error loading data: {e}")
    
    def save_data(self):
        """Save submission data to JSON file"""
        data = {}
        for sub_id, submission in self.submissions.items():
            sub_dict = asdict(submission)
            # Convert date objects to strings
            for date_field in ['submission_date', 'target_approval_date', 
                             'actual_approval_date', 'last_updated']:
                if sub_dict.get(date_field):
                    sub_dict[date_field] = sub_dict[date_field].strftime('%Y-%m-%d')
            
            # Convert enums to strings
            sub_dict['submission_type'] = sub_dict['submission_type'].value
            sub_dict['submission_status'] = sub_dict['submission_status'].value
            
            data[sub_id] = sub_dict
        
        with open(self.data_file, 'w') as f:
            json.dump(data, f, indent=2)
    
    def add_submission(self, submission: RegulatorySubmission):
        """Add new regulatory submission"""
        self.submissions[submission.submission_id] = submission
        self.save_data()
        print(f"Added submission: {submission.submission_id}")
    
    def update_submission_status(self, submission_id: str, 
                               new_status: SubmissionStatus, 
                               notes: str = ""):
        """Update submission status"""
        if submission_id in self.submissions:
            self.submissions[submission_id].submission_status = new_status
            self.submissions[submission_id].notes = notes
            self.submissions[submission_id].last_updated = datetime.date.today()
            self.save_data()
            print(f"Updated {submission_id} status to {new_status.value}")
        else:
            print(f"Submission {submission_id} not found")
    
    def get_submissions_by_status(self, status: SubmissionStatus) -> List[RegulatorySubmission]:
        """Get all submissions with specific status"""
        return [sub for sub in self.submissions.values() if sub.submission_status == status]
    
    def get_overdue_submissions(self) -> List[RegulatorySubmission]:
        """Get submissions that are overdue"""
        today = datetime.date.today()
        overdue = []
        for submission in self.submissions.values():
            if (submission.target_approval_date and 
                submission.target_approval_date < today and 
                submission.submission_status not in [SubmissionStatus.APPROVED, 
                                                   SubmissionStatus.REJECTED, 
                                                   SubmissionStatus.WITHDRAWN]):
                overdue.append(submission)
        return overdue
    
    def generate_status_report(self) -> str:
        """Generate comprehensive status report"""
        report = []
        report.append("REGULATORY SUBMISSION STATUS REPORT")
        report.append("=" * 50)
        report.append(f"Generated: {datetime.date.today()}")
        report.append("")
        
        # Summary by status
        status_counts = {}
        for status in SubmissionStatus:
            count = len(self.get_submissions_by_status(status))
            if count > 0:
                status_counts[status] = count
        
        report.append("SUBMISSION STATUS SUMMARY:")
        for status, count in status_counts.items():
            report.append(f"  {status.value}: {count}")
        report.append("")
        
        # Overdue submissions
        overdue = self.get_overdue_submissions()
        if overdue:
            report.append("OVERDUE SUBMISSIONS:")
            for submission in overdue:
                days_overdue = (datetime.date.today() - submission.target_approval_date).days
                report.append(f"  {submission.submission_id} - {days_overdue} days overdue")
            report.append("")
        
        # Active submissions requiring attention
        active_statuses = [SubmissionStatus.SUBMITTED, SubmissionStatus.UNDER_REVIEW, 
                          SubmissionStatus.ADDITIONAL_INFO_REQUESTED]
        active_submissions = []
        for status in active_statuses:
            active_submissions.extend(self.get_submissions_by_status(status))
        
        if active_submissions:
            report.append("ACTIVE SUBMISSIONS REQUIRING ATTENTION:")
            for submission in active_submissions:
                report.append(f"  {submission.submission_id} - {submission.product_name}")
                report.append(f"    Status: {submission.submission_status.value}")
                report.append(f"    Target Date: {submission.target_approval_date}")
                report.append(f"    Authority: {submission.regulatory_authority}")
                report.append("")
        
        return "\n".join(report)

def main():
    """Main function for command-line usage"""
    tracker = RegulatoryTracker()
    
    # Generate and print status report
    print(tracker.generate_status_report())
    
    # Example: Add a new submission
    # new_submission = RegulatorySubmission(
    #     submission_id="SUB-2024-001",
    #     product_name="HealthTech Device X",
    #     submission_type=SubmissionType.FDA_510K,
    #     submission_status=SubmissionStatus.PLANNING,
    #     target_market="United States",
    #     target_approval_date=datetime.date(2024, 12, 31),
    #     regulatory_authority="FDA",
    #     responsible_person="John Doe"
    # )
    # tracker.add_submission(new_submission)

if __name__ == "__main__":
    main()