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

FDA's "Accredited Persons" 510(k) review program

This article was originally published in The Gray Sheet

Executive Summary

Seven additional Class II devices are deemed eligible for the program, which begins Nov. 21. The seven hematology products are multipurpose system for in vitro coagulation studies (calibrators only) (21 CFR 864.5425); fibrinogen determination system (calibrators only) (864.7340); whole blood hemoglobin assays (calibrators only) (864.7500); calibrator for cell indices (864.8150); calibrator for hemoglobin or hemotocrit measurement (864.8165); calibrator for platelet counting (864.8175); and calibrator for red cell and white cell counting (864.8185). In addition, six more third parties have been accredited to participate since the agency initially accredited seven organizations in early October ("The Gray Sheet" Oct. 5, p. 18). The six groups are: Applied Science & Technology Associates; Center for Measurement Standards of Industrial Technology Research Institute; Cheiroon BV; Entela, Inc.; Intertek Testing Services; and N.V. Kenna. A list of the devices which each group is eligible to review appears on FDA's website (www.fda.gov/cdrh/modact/accredit.html)
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT010974

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