Implementing the 510 (K) correctly in compliance with the latest proposed FDA changes

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 premarket approval (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. The FDA provides guidance on these.

Needed: A thorough understanding of these aspects and the FDA’s latest proposed changes

In accordance with the concern evinced by many industry groups and associations, the FDA introduced as many as 60 proposals in August 2010, into the manner in which the 510 (K) process could be expedited. This was done with the intention of accelerating the speed at which newly approved medical devices could be made available to patients across the country. However, with the number of proposals being too many and their scope being too wide; the medical industry suggested that the FDA select for implementation only those proposals that enjoyed the broad consensus of the stakeholders, such as increased reviewer training, development of specific and relevant guidance documents, and enhancements or improvements to the de novo review pathway, among other suggestions.

An upcoming seminar by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance industries, will clarify on these areas taken up for immediate change by the FDA and place them in the right context. It will address key resources when making critical decisions. This seminar will offer important insights into the core areas of premarket notifications, as well as the Design Control requirements under QS regulations and Design Controls.

To enroll for this seminar, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900527SEMINAR.

The Director at this seminar is David R. Dills, a senior Regulatory Affairs & Compliance Consultant. David 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.

An understanding of the core elements of the PMA

At this seminar, David will help participants understand how medical device manufacturers can locate a "predicate" device and go through the content and format of the 510(K), and offer 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.

He will also offer understanding of 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.

Understanding supplier management for medical devices

The problem with a supplier management program lies in the fact that the FDA audits suppliers only for finished devices. Because of this, manufacturers need to have a high degree of control over them. So, where is the problem? It lies in the FDA’s interpretation of these expectations. This keeps changing from time to time. Over the past five years, these expectations have changed considerably. Manufacturers whose devices have been around for more than five years need to thus make substantial changes into their cGMPs, hence the emphasis on the ‘c’, meaning “current”.  

A seminar from the guru of supplier management

The underlying principles of supplier management will be the basis for a two-day seminar that is being organized by GlobalCompliancePanel, a reputable provider of professional trainings for the areas of regulatory compliance. The Director of this course, Betty Lane, who is the founder and President of Be Quality Associates, LLC, a consulting company that helps small and medium sized medical device and diagnostic companies implement and improve their Quality Systems, will be the Director of this seminar.

To enroll for this very valuable learning session, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900595SEMINAR?medical-device-manufacturers-Switzerland. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Analogous to the FDA’s thinking, European Notified Bodies also periodically update their expectations. Suppliers are now expected to remain current with a guidance document published by the Notified Body Operations Group (NBOG). This seminar will explore the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation on supplier management by expanding on them to cover other issues and techniques important in effective implementation.

Tools, templates and methods of supplier management

Betty will familiarize participants with the nitty gritty of supplier management by building upon it with the tools, templates, and methods needed for implementing an effective and efficient supplier management program. These tools consist of practical exercises which the Director will get the participants to perform.

She will also use FDA Warning Letters to illustrate the points and help the participants learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. These practical steps are aimed at fortifying and reinforcing their understanding of the topic. It will also offer the kind of interactivity with which the participants can understand the concepts threadbare.

The insight the Director will be offering into the area of supplier management will be the highlight of this seminar. This has been accumulated over years and years of experience that the Director has gained in the area of supplier management in medical devices. The Director will detail and examine the concept of risk from the perspective of both the supplier and the regulatory bodies with depth and clarity. She will also review requirements and expectations of the FDA and European Notified Bodies for supplier management, and then show how to incorporate these into the participants’ own supplier management process.