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


In Brief: IMDMC petition

This article was originally published in The Gray Sheet

Executive Summary

IMDMC petition: Rep. David McIntosh (R-Ind.) urges FDA "to move forward" on a response to the Indiana Medical Device Manufacturers Council's May 1995 citizens petition on the agency's use of guidance documents ("The Gray Sheet" May 22, 1995, p. 3). In an Aug. 6 letter to FDA Deputy Commissioner for Policy William Schultz, the Indiana Republican notes that "it has been well over a year" since the trade group submitted its petition and recommends FDA "set a completion date" for the response. In addition, McIntosh asks for a status report on the IMDMC issue, "an outline for FDA's future plan for developing a response to the petition," and a "summary of the anticipated form(s) of FDA's response to the full range of rulemaking and guidance issues raised by the petition." FDA has proposed a series of "good guidance practices" to address several of the issues in the petition ("The Gray Sheet" March 11, I&W-2); the agency hopes to finalize the GGPs before the end of the year. FDA's device center has implemented its own guidance policy until the agency-wide GGPs are completed...

You may also be interested in...

UK Grants First Worldwide Authorization For PfIzer/BioNTech COVID-19 Vaccine

The UK has approved the mRNA-based vaccine just nine days after receiving the final Phase III results from Pfizer.

Wockhardt Preps To Deliver 100M Doses Of AZ Vaccine

As the MHRA prepares to grant approval to the Oxford/AstraZeneca vaccine, Wockhardt is set to supply 100 million doses for the UK government’s own use and its WHO commitments. The company is also in talks with global vaccine developers to manufacture their COVID-19 vaccines for emerging economies

ECHA Deliberates On Final Microplastic Proposal As Beauty Industry’s Fate Hangs In Balance

A combined final opinion on the European Chemicals Agency’s proposed microplastic restriction is expected from ECHA committees by year-end, at which point the European Commission will consider whether and when microplastic must be removed from all leave-on cosmetic products marketed in the EU.




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