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


AdvaMed Moves MedTech Conference Online

Executive Summary

The largest medical device lobby group will host its annual conference online instead of in person. The meeting that had been set to occur over three days in Toronto will now take place in September and end in October.

You may also be interested in...

Pandemic Could Cause FDA To Miss User-Fee Deadlines

In a new temporary guidance document from the US FDA, the agency says while it’s still meeting its deadline obligations for premarket applications under its user-fee agreement with industry, it may end up missing future deadlines due to strains on the agency from COVID-19. In such cases, the FDA says it will get back to the sponsor about setting a new estimated deadline.

Q&A: New Details Emerge From FDA About Long-Delayed Draft Rule That Harmonizes Quality System Reg With ISO 13485

Melissa Torres, a US FDA official who is one of many working on the agency’s revision of the Quality System Regulation, offered a few nuggets of news about the process on 8 June. Among them: device makers will have “a few years” to comply with the new QSR; the Quality System Inspection Technique (QSIT) will change; investigators and device center staff will undergo training; and more.

MDUFA Meeting Postponed Again Due To COVID-19, This Time Indefinitely

The COVID-19 crisis had already forced the US FDA to postpone its first public meeting on the medical device user-fee negotiations to early next May, which was to be webcast. Now the agency has postponed the meeting indefinitely.

Related Content





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