MEDICAL DEVICES 2012 - How to Format a Succinct and Comprehensive 510(k) Submission

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Category 510(k) Submission, Recent Changes in the 510(k) Program, 510(k) premarket notification, 510(k) submission format, 21 CFR 807.92(a)(3), 510(k) actions and improvements

Deadline: January 17, 2012 | Date: January 17, 2012

Venue/Country: Palo Alto, U.S.A

Updated: 2011-12-08 20:43:41 (GMT+9)

Call For Papers - CFP

Why Should You Attend:

Recently, the 510(k) program has been evolving (e.g., 510(k) actions and improvements). In addition, the recent FDA draft guidance document suggests that more 510(k) submissions be required to meet the regulatory requirements. It is imperative that medical device industry quickly recognize the recent changes in the 510(k) process, and understand and adapt to the recent changes/requirements to greatly facilitate the review in a proactive and streamlined manner.

Areas Covered in the Seminar:

- Changes in 510(k) program.

- 510(k) regulatory requirements.

- 510(k) submission requirements for medical devices and in vitro diagnostic devices.

- Review of FDA regulations applicable to a 510(k) submission.

- List of applicable FDA guidance documents.

- List of applicable reference standards.

- Systematic methods to increase 510(k) submission quality.

- 510(k) formatting in a succinct and comprehensive manner ready for submission.

- 510(k) submission template for medical devices.

- 510(k) submission template for in vitro diagnostic devices.

- Instructor's unique 510(k) strategy guide.