Bullet Proof 510(K) – Latest FDA Changes to the Process

Compliance4All announces webinar on the topic, “Bullet Proof 510(K) – Latest FDA Changes to the Process” on September 1. This three-hour session will give a detailed overview of the premarket notification, the 510 (K).

Fremont, CA: Compliance4All, a provider of cost-effective regulatory compliance trainings for a wide range of regulated industries, will organize a webinar on September 1. The topic of this webinar is “Bullet Proof 510(K) – Latest FDA Changes to the Process”. The speaker at this webinar is David R. Dills, a senior Regulatory Affairs & Compliance Consultant.

About the webinar:

This webinar will offer important insights into the core areas of premarket notifications, as well as the Design Control requirements under QS regulations and Design Controls.

For more information or to register for the webinar, please click here.

A 510(K) is a premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective, meaning that which is substantially equivalent, to a legally marketed device that is not subject to PMA.

There are three types of Premarket Notification 510(K)’s that may be submitted to FDA: Traditional, Special, and Abbreviated.

Product modifications that could significantly affect safety and effectiveness are subject to 510(K) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance with 21 CFR 820.30 Design Controls. FDA provides guidance on these, and this webinar will address key resources when making critical decisions.

The speaker at this webinar will help participants understand all the crucial aspects of the PMA, such as the differences between the Traditional, Special and Abbreviated submissions, an understanding of the Substantial Equivalence and how it is applied, who is required to submit the application to FDA, where to submit the 510(K) and what to expect with the review and approval process, when a device company requires this process and when it does not, the applicable exemptions to the submission process and special considerations, and so on.

He will also offer understanding of how medical device manufacturers can locate a “predicate” device and go through the content and format of the 510(K), and an understanding of the De Novo process and the expectations for possibly marketing a low risk device, and the potential impact of FDA’s proposed changes to the 510(K) process and why manufacturers need to pay attention to these.

About the Speaker:

David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems.

About Compliance4All:

Compliance4All (http://www.Compliance4All.com/) is a specialized offering from NetZealous, a Fremont, CA-registered organization. It is a source for a wide range of professional trainings, compliance trainings and consulting for the regulated industries. Compliance4All offers a broad range of high quality, affordable regulatory and compliance-related services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biologicals, drugs, food and biotechnology.

Many professionals in the various areas in which Compliance4All offers its trainings have benefited from the vast experience of its well-known speakers, who are reputed globally in their respective fields.

Contact information:

Call: 1-800-447-9407;

Visit: http://www.netzealous.com/