Medtech Insight is part of the Business Intelligence Division 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

QUOTED. Feb. 13, 2018. Ricki Chase.

Executive Summary

Check out what former US FDA investigations branch director (and current industry consultant) Ricki Chase had to say about the regulations that companies must comply with if they make combination device/drug products.

"The primary function of … combination products is usually the drug or biological component. In those instances, 21 CFR Part 211 [US FDA's regulation for drugs] would be the primary focus. However, the differences are that in 21 CFR Part 820 [FDA's Quality System Regulation for devices], the management responsibilities are slightly different and need to be addressed. [And] obviously, there are design controls, which are unique to the design component of the device, which you would not normally see in pharma or biologic manufacturing, and clearly are not stated in Part 211." –Ricki Chase, compliance practice director, Lachman Consultant Services

Click here for a free trial of Medtech Insight

Advertisement

Related Content

Compliance 360° Part 12: Navigating The Quicksand Of Device/Drug Combo Products (1 of 2)

Topics

Advertisement
UsernamePublicRestriction

Register

MT122190

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