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

In Brief: Medical device reporting

This article was originally published in The Gray Sheet

Executive Summary

Medical device reporting: FDA stays effective date of certain portions of the annual baseline reporting requirement of the agency's December 1995 final manufacturer MDR rule. The stay, published in the July 31 Federal Register, applies to the number of devices manufactured, distributed or in use (so-called "denominator data"), which FDA had intended to use in determining the prevalence of adverse events. The agency is issuing the stay "until further notice" in response to device industry concerns about the provision. FDA will explore mechanisms for obtaining denominator data via a small-scale pilot project slated to begin this fall ("The Gray Sheet" July 15, p. 10). The remaining portions of the MDR rule became effective as scheduled July 31...

You may also be interested in...



Civica Rx Gets $55m Investment

Civica Rx has won an investment of $55m through a deal with the Blue Cross Blue Shield Association of US health insurance firms to create a new subsidiary that will acquire and develop generic filings to be launched in the US from 2022.

Pfizer’s US Rituximab Launched At A 24% Discount

Pfizer has launched its Ruxience rituximab biosimilar in the US at a 24% discount to the wholesale acquisition cost of the Rituxan original. The firm has also revealed that when it launches its Trazimera trastuzumab biosimilar in mid-February, it will be at a 22% discount to the Herceptin brand’s WAC.

Teva Leapfrogs Mylan And Sandoz On Linaclotide

A patent-litigation settlement that Teva has reached with Ironwood and Allergan over Linzess will allow the Israeli firm to enter the US market with the linaclotide-based constipation treatment ahead of major rivals Mylan, Sandoz, Sun Pharma and Aurobindo.

UsernamePublicRestriction

Register

MT006467

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