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


Draft Guidance On PMA Annual Reports Focuses On Device Modifications

This article was originally published in The Gray Sheet

Executive Summary

A draft guidance detailing what FDA expects manufacturers to include in annual reports for PMA-approved devices is less burdensome to industry than expected

You may also be interested in...

Regulatory Briefs: FDA Meetings On Cancer Tests, Glaucoma Devices; DeLauro Questions Device Reclassifications

An FDA advisory panel will discuss PMAs for two molecular diagnostics for colorectal cancer screening in March. A February workshop will address clinical trial design for minimally invasive glaucoma devices. Rep. DeLauro speaks out about FDA device reclassifications. More regulatory briefs.

FDA Manufacturing-Change Reviews Will Shift From Compliance Office To ODE

The move is in line with the agency’s intention to focus on the total product life-cycle, such that the same staffers that review an original marketing submission will look at the safety and effectiveness of manufacturing changes.

Regulatory Affairs Professionals Society Meeting In Brief

PMA supplement guidance, finally?: "I'm going to go out on a limb and say it will be out by the end of the calendar year," Office of Device Evaluation Director Donna-Bea Tillman said Oct. 16 at the Regulatory Affairs Professionals Society (RAPS) annual meeting in Baltimore in reference to a highly-anticipated PMA product modification guidance. The guidance, which is expected to define specific PMA supplement types and lay out criteria for when to proceed with each, will replace a 1998 guidance on the topic that FDA removed from its website in 2005 (1"The Gray Sheet" May 30, 2005, p. 3). CDRH PMA Section Director Thinh Nguyen had told an audience at the 2005 RAPS meeting to expect the guidance in early 2006. "It's been a very difficult guidance. A lot of different people have had to see it and weigh in on it," Tillman said. "We know that the industry wants that guidance"...

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