The FDA’s Guidance on Wireless Devices

The U.S. FDA released a guidance document on wireless medical devices, “Radio Frequency Wireless Tehnology in Medical Devices”. Its purpose is to address the growing use of wireless technology in medical devices in support of health care and new avenues for risk, such as signal interference / interruption.

FDA stated: “It is essential that manufacturers first consider and test potential limitation of the wireless connectivity associated with their devices to prevent manfunctions that could harm patients.”

This is a relatively new, but growing field. Our instructor, a renown industry expert, John E. Lincoln has regulatory experience in wireless devices and has prepared two such 510(k)s. He recently published a journal article on this new guidance. In this webinar he will also discuss the consideration of the FDA’s concerns over which device functions could be made wireless, and which should employ wired connectivity.

Areas Covered in the Session : 

• The Guidance focuses on two areas, as will this webinar:
• Considerations for Design, Testing and Use of Wireless Medical Devices
• Recommendations for Premarket Submissions for Devices that Incorporate RF Wireless Technology.
• Security issues and electromagnetic compatibility (EMC).
• The risk-based approach to verification and validation of such devices
• Unique labeling requirements.

Who Should Attend:

This webinar will provide valuable assistance to all regulated companies that are or anticipate having products in this growing market. Its principles apply to personnel / companies primarily in the Medical Devices fields. The employees who will benefit include:

• Senior management
• Middle management
• R&D
• Engineering
• Software
• QA / RA
• Manufacturing
• Operations
• Consultants
• cGMP instructors

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.