When to Submit a 510(k) for a Change to an Existing Device

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Category FDA 510K Changes, fda 510 k database, fda medical device, Compliance Trainings, fda 510 k guidance documents, vitro diagnostic devices, Regulatory Agency Investigators

Deadline: August 12, 2018 | Date: August 14, 2018

Venue/Country: Online, U.S.A

Updated: 2018-06-07 14:31:44 (GMT+9)

Call For Papers - CFP

This presentation, will aid manufacturers of medical devices who

intend to modify a 510(k)-cleared device or a preamendments

device subject to 510(k)

Why should you Attend:

This presentation uses the latest FDA thinking and guidance

documents to assist the manufacturers in enhancing the

predictability, consistency, and transparency of the "when to

submit" decision-making process by providing a least burdensome

approach, and describing in greater detail the regulatory

framework, policies, and practices underlying such a decision.

Areas Covered in the Session:

The main types of changes that might be made to a device: When

a manufacturer modifies their device with the intent to

significantly affect the safety and effectiveness of a device (for

example to significantly improve clinical outcome or to mitigate a

known risk) submission of a new 510(k) is likely.

Who Will Benefit:

Quality Managers

Quality Engineers

Regulatory Affairs

Small Business Owners

Speaker Profile:

Angela Bazigos is the CEO of Touchstone Technologies Inc. She

has degrees in Microbiology and Computing and 40 years of

experience in the Life Sciences, Healthcare & Public Health

Services. Experience combines Quality Assurance, Regulatory

Compliance, Business Administration, Information Technology,

Project Management, Clinical Lab Science, Microbiology, Food

Safety & Turnarounds.

Event Fee: One Dial-in One Attendee Price: US $290.00

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: supportcompliance4All.com