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


FDA Crafting Guidance On Digital Slide Imaging Systems With Panel Input

This article was originally published in The Gray Sheet

Executive Summary

FDA is developing guidance for industry and agency reviewers on pre-market submissions for digital slide imaging systems used in place of conventional light microscopes to study pathology specimens

You may also be interested in...

Regulatory News In Brief

Power cord investigation: FDA is investigating power cords used in devices manufactured by Abbott, Hospira and other firms. Abbott and Hospira have collectively sent FDA 122 reports of sparking, charring and fires from defective device AC power cords manufactured by Westfield, Pa.-based Electri-cord Manufacturing Co. The power cord's prongs may crack and fail, potentially causing electrical shock, therapy delays or interruption, device failure or fires. FDA is determining which other device firms have been supplied with the cords and recommends that manufacturers that use the cords initiate voluntary recalls and report any adverse events to FDA. Hospira recalled more than 30 types of devices with the defective cords Aug. 14 (1"The Gray Sheet" Aug. 24, 2009). Electri-cord said Aug. 19 the problems must be related to "abusive use," such as yanking the cord out of the wall, rather than a manufacturing defect

Chloroquine ‘Approval’ For COVID-19 And The US FDA’s New Reality

Asking whether FDA’s decision to allow emergency use of two old anti-malarial drugs was ‘political’ misses the point. The issue already was political, and FDA’s action may well be the best way to keep some measure of federal control on supplies of a drug with important other uses.

Biopharma, Payers Seek National Guidelines For Prescribing Potential COVID-19 Drugs

Guidelines for health care providers could help prevent shortages as demand for possible treatments surge, groups say. Stakeholders also argue “Buy America” executive order would hamper drug access.





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