FDAnews Announces — FDA’s Final Custom Medical Device Guidance: New Reporting Requirements, Narrower Uses Allowed Webinar, Jan. 20, 2015

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The FDA has recently issued a final guidance on custom medical devices. Mark the calendar for Tuesday, Jan. 20, when regulatory expert J. Mason Weeda Esq. sheds light into the dark corners of custom-device regulation, in this all-new FDAnews

FDA’s Final Custom Medical Device Guidance:
New Reporting Requirements, Narrower Uses Allowed
**FDAnews Webinar**
Jan. 20, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/MedDevGuidance

The FDA has recently issued a final guidance on custom medical devices.

Could the new annual reporting and filing requirements cost devicemakers valuable time and money?

Mark the calendar for Tuesday, Jan. 20, when regulatory expert J. Mason Weeda Esq. sheds light into the dark corners of custom-device regulation, in this all-new FDAnews webinar.

Custom devices are mostly exempt from FDA regulation, premarket approval or clearance. But the line can grow unclear between a product that requires approval and one that doesn’t. The final guidance seeks to shed light on such murky matters, including:

  • If a component in an already implanted device fails and the manufacturer builds a replacement, is that new part a custom device?
  • If a manufacturer makes a custom device in multiple sizes to make sure of correct fit, is this a single or multiple device? The question matters, because the FDA exempts from regulation up to five custom devices per year.
  • If one patient needs several copies of one device, is that a single or multiple device?

Mr. Weeda walks attendees through these complexities and many others. Attendees will discover:

  • How the interpretation of a custom device has changed over time
  • How to use the FDA’s supplied Custom Device Decision Tree flowchart to determine if a device is a considered a custom device
  • Clarification of the five-units-per-year requirement so devicemakers don’t exceed allowable limits and risk regulatory sanctions
  • Best practices for filling out Appendix I — Format For The Summary Tables — to assure proper annual reporting
  • How to properly submit reports to FDA under their eCopy system
  • And much more!

If a manufacturers produces custom devices, this webinar will show how to stay within the five-unit-per-year limit. And all participants will learn to tell when the FDA is likely to deem a specific device “custom,” and how to properly report custom-device production.

Meet the Presenter:
J. Mason Weeda Esq., Olsson Frank Weeda Terman Matz, represents medical device, biologics, pharmaceutical and food manufacturers, distributors and importers in matters involving FDA regulation and HIPAA. He is an expert on import issues involving FDA-regulated products, including import holds, detentions, and refusals, as well as offering regulatory due-diligence opinions to financial and other companies considering purchase of an FDA-regulated entity.

Who Will Benefit:

  • Consultants/service providers
  • Engineering and design controls teams
  • Compliance officers
  • Executive management
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • QA/QC personnel
  • R&D staff
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Strategic planning and business development staff
  • Attorneys/legal department

Conference Details:
FDA’s Final Custom Medical Device Guidance:
New Reporting Requirements, Narrower Uses Allowed
**FDAnews Webinar**
Jan. 20, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/MedDevGuidance

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/MedDevGuidance
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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