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.

Menu

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
Menu
My View
  • Edit
  • Add your favourite topics for quick access
Meet the Team
Ask The Analyst
Partnered Content
PDF Library
RSS Feeds
Subscribe
FAQs
Advertising
PR Newswire
Report Store
UsernamePublicRestriction
Tags:
Medical Device Regulation Compliance

Warning Letter Roundup & Recap –December 22, 2015

This article was originally published in The Gray Sheet

  • News

Executive Summary

Device firm Elite Massagers received two complaints – including one that described a user being shocked by an Elite Multi device – yet failed to investigate; Dutch Ophthalmic Research Center cited for premarket violations. Two device warning letters were listed by FDA last week.

You may also be interested in...



ASTM Developing Standard To Tackle Dried Blood On Steel Devices

ASTM International is proposing a new standard that will provide a cleaning agent formula for removing dried blood from stainless steel medical devices.

Executives On The Move: CEOs Named At Elevation Oncology, PainReform Ltd

Executive appointments at MyoKardia, Scancell Holdings and Sutro Biopharma

Viatris Kickstarts Business With Tentative Approval For Pediatric Dolutegravir

The merger between Mylan and Pfizer’s Upjohn unit finally concluded on 16 November 2020, giving Viatris the go ahead for business. The newly-established company has announced receiving tentative approval for its 10mg pediatric dolutegravir tablets from the FDA under the PEPFAR program. 

Table

View full table

Topics

Tags:
Medical Device Regulation Compliance
UsernamePublicRestriction

Register

OM001644

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

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