Devicemaker’s Guide to FDA Premarket Submissions

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Devicemaker’s Guide to FDA
Premarket Submissions
Volume 1 – The Premarket Approval Process
Volume 2 – 510(k) and De Novo Applications

There are three primary pathways to gaining FDA authorization to market a new device — Premarket Application (PMA), 510(k) Premarket Notification and De Novo classification — each with its own unique set of rules and procedures.

Before you can approach the FDA for marketing authorization, you must know which of the three pathways to follow.

The decision comes down to three questions:

  • Does the device present a high risk and require comprehensive scientific investigation to prove its safety? You’ll need to go through the PMA process.
  • Is the device less risky and similar to another product already on the market? If you can prove “substantial equivalence” to the other device, the 510(k) program is the best fit.
  • Is the device low risk but without a reference product already on the market? The De Novo pathway is designed to handle these devices without putting them through the unnecessary rigor of scientific investigation to prove their safety.

The Devicemaker’s Guide to FDA Premarket Submissions includes all of the information and documents you need to navigate the FDA’s marketing process in two volumes. 

In Volume 1 you’ll find more than 200 pages of FDA guidances on the PMA process, including:

  • Acceptance and Filing Reviews for Premarket Approval Applications
  • Premarket Approval Application Modular Review
  • Supplements to Approved Applications for Class III Medical Devices
  • PMA Interactive Procedures for Day-100 Meetings
  • Procedures for Handling Post-Approval Studies Imposed by PMA Order
  • Quality System Information for Certain Premarket Application Reviews
  • Real-Time PMA Supplements
  • 21 CFR Part 814 — Premarket Approval of Medical Devices

Volume 2 (more than 380 pages) contains guidances for the 510(k) and De Novo processes, including:

  • Evaluating Substantial Equivalence in Premarket Notifications
  • Deciding When to Submit a 510(k) for a Change to an Existing Device
  • Determination of Intended Use for 510(k) Devices
  • Format for Traditional and Abbreviated 510(k)s
  • Refuse to Accept Policy for 510(k)s
  • Evaluation of Automatic Class III Designation
  • Federal Regulations at 21 CFR Part 807, Subpart E — Premarket Notification Procedures

This comprehensive two-volume set pulls together all of the device marketing submission documents needed to determine your pathway.


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