Webinar On The FDA Medical Device Approval Process: Preparation of 510(k)s, IDEs, PMAs

This web presentation presents an overview of the requirement to obtain FDA permission to market a Medical Device products.

We will discuss the regulatory requirements and the various FDA submissions, the 4 types of 510(k)s and the contents of each. We will also discuss the contents and requirements for IDEs and PMAs, guidelines for each aspect of research are provided, as well as information on the structuring of submissions and post-approval documents. Attendees will get a better understanding of the FDA Medical Device Approval Process and the underlying scientific and regulatory principles involved. The course enables regulatory affairs professionals to provide the FDA with necessary information and obtain product approval.

Areas Covered in the Session :

    Navigate the FDA medical device approval system

    Preparing contents of the 4 types of 510(k)s

    Preparing contents of an IDE

    Preparing contents of a PMA

    Non-significant risk devices

    Significant risk devices

Who Will Benefit:

    Regulatory Affairs Personnel

    Quality Personnel

    Clinical Personnel

    Research Personnel

    Manufacturing Personnel

    Auditors

    Legal Personnel

    Personnel who require an understanding of the FDA Medical Device Approval Process

Price Tags:

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

Speaker Profile

Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical.

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