Master FDA Regulatory Affairs USA

Master FDA Regulatory Affairs USA free download

Manage medical devices regulatory activities in the USA

Master medical devices registration in the most important and biggest market ever in the world, the market of the USA, this market could be missed by any pharmaceutical or healthcare company, all the pharma industry professionals understand very well the weight of this market, how huge it is, and what is the expected revenue out of it.

The Food and Drug Administration (FDA) is the regulatory authority in the United States responsible for ensuring the safety, efficacy, and quality of pharmaceuticals, biologics, medical devices, food, cosmetics, and tobacco products. It operates under the U.S. Department of Health and Human Services (HHS)

What will you learn?

• Get introduced to the FDA

• Master FDA interface

• Master FDA regulatory processes

• Get introduced to 510 K, its types and conditions

• Get introduced to PMA, its types and conditions

• FDA Classification Rules

• FDA QMS system

• Master FDA database

• FDA Pharmacovigilance practicing

We will be introduced to Medical Device Regulation

• Reviews medical devices via:

  • 510(k) Pre-market Notification (for substantially equivalent devices).

  • Premarket Approval (PMA) (for high-risk devices).

  • De Novo Pathway (for novel devices).

• Ensures post-market surveillance and device recalls.

We will be introduced to FDA Good Manufacturing Practices (GMP) & Compliance

• Enforces Good Manufacturing Practice (GMP) for pharmaceuticals and biologics.

• Inspects manufacturing plants to ensure quality control and regulatory compliance.

• Works with Customs and Border Protection (CBP) to regulate imported drugs.

  
  

  We will master FDA Drug Approval Pathways

• New Drug Application (NDA) – Required for brand-name drug approvals.

• Abbreviated New Drug Application (ANDA) – For generic drugs.

• Biologics License Application (BLA) – For biologics and biosimilars.

• Investigational New Drug (IND) Application – Required before human clinical trials.

• 505(b)(2) Pathway – Hybrid approval process for modified drugs.

What is FDA Expedited Programs?

• Fast Track – For serious conditions with unmet medical needs.

• Breakthrough Therapy – For drugs showing superior effectiveness.

• Accelerated Approval – Based on surrogate endpoints.

• Priority Review – 6-month review timeline for urgent drugs.

Getting introduced to Pharmacovigilance & Adverse Event Reporting

• FAERS (FDA Adverse Event Reporting System) – Tracks adverse drug reactions.

• MedWatch – Public reporting system for drug safety concerns.

• Risk Evaluation and Mitigation Strategies (REMS) – Required for high-risk drugs.

FDA’s Global Role & Collaboration

• Works with EMA (Europe), MHRA (UK), Health Canada, WHO, and ICH to harmonize drug regulations.

• Inspects foreign drug manufacturing plants to ensure GMP compliance.

So, from a business point of view, you can place your product in the market quite faster and start earning your revenue quite fast also, moreover, the medical devices world is highly dynamic and innovative, compared to the pharmaceuticals, with lots of innovations and different versions of the same medical device could be played within the potential market of the USA.

Dear pharma industry future professionals, let us start our interesting journey toward medical device registration in the states, we will travel together to the states, meet the health authority there "FDA", and explore its requirements for registration, renewal, and variations, let us get our FDA approval and place our products there.

In this course, we will cover all topics related to medical devices in the USA, starting from the requirements, interim regulations, classification, verification, special conditions, and weavings

And finally, congratulations to you for mastering medical device registration in the USA market and see you soon in the pharma industry my dear colleagues.

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