RAC Study Group 2025 Week 3: Regulatory Strategy

Flashcards covering regulatory strategy in the US, EU, and internationally, including FDA communications, regulatory frameworks, and counterfeit prevention.

Citizen Petitions

Formal requests to the FDA to take or refrain from taking administrative action, with the FDA required to respond within 180 days.

Informational Meeting (FDA)

A meeting where a sponsor shares information with the FDA without requesting formal feedback.

Submission Issue Request (SIR)

A sponsor's request to discuss items identified by the FDA during a submission review.

PMA Day 100

Discusses a PMA's review status, with the FDA providing feedback by 90 days or at least 10 days prior to the meeting.

Private 2-way Conversations (FDA)

Meetings that may be formal or ad-hoc, via phone/email/in-person, for discussions on missing submission information or disagreements.

Practice with the Meeting in Mind

Ensuring all team members are aligned and technology works before an FDA meeting.

Document Feedback (FDA Meetings)

Striving for clear agreement on critical decisions and documenting them in sponsor-driven meeting minutes.

Intent of Regulatory Strategies

Aligning the business strategy of bringing a new or modified product to market with the necessary regulatory and quality compliance activities.

Cross-functional Team Collaboration (Regulatory Strategy)

Determining if outside experts are needed to determine critical milestones and high-level deliverables in the project.

FDA Device Registration and Listing

Locations of medical device establishments and the devices manufactured at those establishments.

Premarket Approval (PMA) Database

Medical device approval materials and labels approved under the PMA pathway, including supplements.

Total Product Life Cycle (TPLC)

Premarket and post-market medical device data, including information about classification codes, PMAs, 510(k) clearances, MAUDE adverse event reports, CDRH recalls, and data about device problems.

FDA Inspection Classification

Final inspection classifications of firms and project areas, including those from CBER, CDER, and CDRH.

Key Considerations During Development and Lifecycle Management (Devices)

What interactions with CDRH are planned, whether clinical studies are required, what the best regulatory pathway is, and what the quality compliance requirements are.

Defining Regulatory Strategy (EU)

Intended to align the regulatory and quality compliance activities required with the business strategy to bring a new or modified product to the market in the desired regions within the desired timeframes.

Starting with the End in Mind (EU Regulatory Strategy)

Essential starting point in developing a regulatory strategy, driving the development program for any product.

Project Plan (EU Regulatory Strategy)

Breaks the regulatory strategy down into critical deliverables and identifies the actions and key stakeholders.

Manufacturers, authorized representatives, importers and distributors identified with formal agreements set

Economic Operators

EUDAMED

Legal manufacturers submit their devices UDI’s to this database.

Falsified Medical Products

Medical products that deliberately or fraudulently misrepresent their identity, composition, or source.

Substandard Medical Products

Authorized medical products that fall outside of their quality standards and/or specifications.

Falsified Device

Any device with a false presentation of its identity, source, and/or its CE marking certs or documents.

US DSCSA Aims

Aims to provide an electronic system solution to identify and trace selected prescription drugs for human use throughout the legitimate US pharmaceutical supply chain.

Falsified Medicines Directive (FMD) Intention

Intended to tighten medicinal product distribution chain control and protect consumers from falsified, recalled, and expired medicines.

WHO Global Surveillance and Monitoring System

To improve quantity, quality, and analysis of accurate data concerning SF medical products and use that data in the better prevention, detection, and response to those products, in order to protect public health.

IMDRF Guidance UDI

To set standards for countries to establish their own UDI frameworks to eventually reach global counterfeit product control

Falsified Medicines Directive Requirements

Unique identifier in a 2D barcode including product code, serial/lot #, expiry date and potentially reimbursement #. and implementation of tamper-evident packaging.

US UDI Requirements for Manufacturers

Manufacturers to print codes on labels, packages, and/or devices and submit required information to the Global UDI Database (GUDID).

DSCSA Challenges

Complexity of supply chain and dispensers’ operability challenges this.

EU UDI Challenges

Substantial costs for industry affect this.

Third Countries Covered by the FMD

These countries have a regulatory framework applicable to active substances exported to the Union and control activities that ensure a level of public health protection equivalent to the EU.

India Medical Device Regulations

2017 risk-based classification system and UDI compliance.

Argentina Medical Device Regulations

UDI in line with FDA will be accepted as part of this standard.

South Korea Medicine Regulations

From 2012, barcode or RFID tag required for selection of drugs and prescription drugs from 2013.

Turkey Medicine Regulations

Unit level serialization and centralized government portal were implemented in 2009.