Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

DESIGN CONTROL INSPECTION SCOPE TO BE CLARIFIED BY FDA IN UPCOMING POLICY STATEMENT; FIRMS WILL CHOOSE WHICH PRODUCTS UNDERGO DESIGN CONTROL AUDITS

This article was originally published in The Gray Sheet

Executive Summary

FDA design control inspections in the first, "transition" year of design control requirements will address design modifications to currently marketed products, new designs reaching transfer to manufacturing, and products for which a premarket approval application, 510(k) or investigational device exemption request have been submitted to FDA, Greg O'Connell, a biomedical engineer in the Center for Devices and Radiological Health's Office of Compliance, said at the Association for the Advancement of Medical Instrumentation annual meeting June 10 in Washington, D.C.

You may also be interested in...



Big Pharma BD Execs Tell Start-Ups: Don’t Be Afraid To Ask Us For Help

Business development leaders and venture capital investors spoke at Biocom’s annual partnering conference about what they are seeking in relationships with entrepreneurs and start-ups.

Transformation Into Viatris Not Seen As The Solution Mylan Needs

Mylan’s full year 2019 earnings report was its last as an independent company, so the focus was on the coming merger with Pfizer’s Upjohn and growth prospects for the new company, Viatris.

HBW Product Launches: VitaFusion Goodness, Colgate Zero, Tom’s Prebiotic, Gaia Hemp & Herb

Colgate Zero toothpastes and mouthwashes promote what’s missing; Tom’s of Maine natural personal care expands with prebiotic toothpaste, deodorant and hand soap; Gaia adds hemp to its herbs; and Church & Dwight goes environmentally friendly with VitaFusion Goodness supplements, adds CBD versions to line, too.

UsernamePublicRestriction

Register

MT008214

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel