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PMA’s, IDE’s, and De Novo Submissions

Duration : 90 Minutes

John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide.  He specializes in quality assuranc Read more


Premarket approval (PMA) is the US FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices to be marketed in the US. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing approval. 

Course Objectives:

There is no specified format of a PMA submission, but there are requirements for its subject matter and content. We will briefly consider the FDA’s requirements of the traditional 510(k) for content ideas. If the device is a high risk device (supports or sustains human life, is of substantial importance in preventing impairment of human health, or presents a potential, unreasonable risk of illness or injury) and has been found to be not substantially equivalent (NSE) to a Class I, II, or III [Class III requiring 510(k)] device, then the device must have an approved PMA before marketing in the U.S. 

As an alternative, some devices that are found to be not substantially equivalent to a cleared Class I, II, or III (not requiring PMA) device, may be eligible for the De Novo process as a Class I or Class II device. Both PMA’s, De Novo, and some 510(k) require clinical trials on humans as part of the submission to the FDA.  If so, an IDE (Investigational Device Exemption) must be submitted for FDA for review to allow the shipment and use of trial devices on human subjects.  In all three cases, PMA, De Novo, and IDE, a clinical site’s IRB (Institutional Review Board) must be involved to further ensure the rights of the trial’s human subjects are protected and informed consent is ensured

Why Should You Attend:

A Premarket Approval (PMA) application is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the Class III device. If a PMA application lacks elements listed in the administrative checklist, FDA will refuse to file a PMA application and will not proceed with the in-depth review of scientific and clinical data. If a PMA application lacks valid clinical information and scientific analysis on sound scientific reasoning, it could impact FDA's review and approval. PMA applications that are incomplete, inaccurate, inconsistent, omit critical information, and poorly organized have resulted in delays in approval or denial of those applications. Manufacturers should perform a quality control audit of a PMA application before sending it to FDA to assure that it is scientifically sound and presented in a well-organized format. This webinar will discuss the key points of these requirements and a possible format (as well as for the other types of submissions to the FDA).

Course Outline:

• U.S. FDA device clearance / approval processes

• Recent “Working Group” findings/recommendations = “tougher”

• The three 510(k)s:  Traditional, Special, Abbreviated

• De Novo

• The IDE

• The PMA

• Basic content requirements and one possible “model”

• Addressing device changes 

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

• R&D

• Risk Managers

• Engineering

• Supervisors

• Business Owners

• General Managers

• Marketing

• Company owners

• Presidents and CEO's

• QA / RA

• Managers

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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