From the FDA CDRH webpage titled “Documents the CDRH is Considering for Development (FY11)” the following is the intoduction to the page:

“This is the list of guidance documents CDRH is considering for development this year (2011). CDRH plans to update this list every year. CDRH invites interested persons to submit comments on any or all of the guidance documents on the list to docket FDA-2007-N-0270. Comments may include draft language on the proposed topics and/or suggestions for new or different guidance documents. CDRH believes this docket is an important tool for receiving information from interested parties and for making information available to the public.

The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CDRH has already issued Level 1 drafts that may be finalized following review of public comments. This list of proposed guidance documents is not binding. CDRH is not required to issue every guidance document on the list and may issue guidance documents not on the list.

Current FDA and CDRH guidance documents can be found on the CDRH Guidance Document page.”

Further along in the description of the process the FDA CDRH says this process is to “provide stakeholders an opportunity to provide comments and/or draft language for those topics as well as suggestions for new or different guidances.”

After talking with the FDA Oct 5 with one of the people that has written some of the draft guidances that will come out later this year he indicated that if the document comes out for public review & comment and there is no feedback that doesn’t make the document as good as it could be.  The FDA is really seeking feedback on the draft guidance documents to make them much better and to be useable by the stakeholders.

The webpage http://ht.ly/2OiXg where the CDRH is considering documents for FY11 has instructions on how to comment on these draft guidance documents.

Also, at the bottom of the webpage http://ht.ly/2OiXg there is a list of “What guidance document is CDRH considering for development during FY 2011?”  The list is over 40 items long and covers areas such as product specific, safety standards, medical device quality systems, guidance on postmarket and compliance issues, among other areas.  Below is a list of some of the draft guidance they hope to publish and get comments on in their FY 11.  Note that not all of these will make it out of FDA by the end of their FY11 (ends Sept 2011):

• Application of IEC 60601-1 Third Edition
• Medical Device ISO 13485
• Radio-Frequency Wireless Technology in Medical Devices
• Medical Device Appeals and Complaints: Guidance on Dispute Resolution
• Medical Devices Containing Materials from Animal Sources (except IVDs)
• Medical Device Home Use
• Medical Device Premarket Clinical Studies: Levels of Evidence
• Manufacturing Site Change Supplements: Content and Inspectional Considerations
• Medical Device Reporting for Manufacturers
• “510k Actions”‐FDA and Industry Actions on Premarket Notification Submissions
• Distinguishing Medical Device Enhancements from Product Recalls and Corrections
• Electronic Medical Device Reporting
• Computed Tomography
• Implantable Cardiovascular Defibrillators
• Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data
• Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data
• Pediatric Information in Diagnostic Medical Device Premarket Submissions

Article reprinted from “The Gray Sheet” – March 15, 2010

FDA is exploring ways to inform industry of changes to its regulatory expectations more quickly than guidance documents or standards development allow, device center director Jeffrey Shuren said last week.

The center is trying to determine when and how to update manufacturers on revisions to standards for getting a new product to market, Shuren explained March 10 at the annual standards and regulation conference hosted by FDA and the Association for the Advancement of Medical Instrumentation (AAMI).

“We may say, ‘We expect a change in design, we may expect a change in how that product is assessed,'” Shuren said. “Well, every time we make that decision, if you’ve got a device in the works, you are going to have to make a change.”

Requiring these changes on an ad hoc, case-by-case basis does not benefit device makers, Shuren said, acknowledging longstanding industry concerns.

But the guidance development process can be slow and requires “a lot of resources,” he noted.

“One of the things we’re thinking is, are there other mechanisms by which we can convey our expectations in a more timely manner, and can we be a little bit more predictable about when our expectations change?” he told conference attendees.

Guidance Development: A Cumbersome Process

Maggie Dietrich, special assistant to Shuren, also pointed out that writing guidance documents, one of FDA’s key methods of communication, is “a very cumbersome process.”

The device industry prefers guidance development, with the industry input it entails, as a way to communicate changes in regulatory expectations. But companies agree that it is important to communicate requirements “as quickly as possible,” Janet Trunzo, executive VP of technology and regulatory affairs at AdvaMed, said in an interview.

“If FDA believes that the guidance document process and internal review process at FDA takes too long, FDA could at least communicate through stakeholder meetings … or perhaps issuing points to consider or the outline of the guidance it is thinking of developing,” Trunzo said.

FDA has already taken steps to improve other early communications tools, such as public health notifications, over the past years, Dietrich said at the FDA/AAMI conference.

“We put out early communications where there’s a concern for us but we’re not quite sure what to do with it, but we want to get people’s attentions to make sure that they understand the state of our current knowledge,” she said.

But AdvaMed has voiced some concerns with this approach.

In February comments to FDA on the issue of incorporating new science into regulatory decisions, the association said the agency has failed in the past to discuss issues involved in public health notifications with all relevant stakeholders, such as device firms or clinicians, leading to “biased notices.”

CDRH Plans Continuum Of Communications

Shuren suggested that companies consider quicker communications tools as part of a continuum.

“We may have a tool by which we say, ‘In this case, here’s what we’re thinking now,’ and we’ll do it fast,” he said. “We might then move to a guidance to provide more details. And then we may still be working on a standard to ultimately put out.”

He pointed to the center’s recent initiative on reducing unnecessary radiation exposure during medical imaging procedures, which involves an FDA white paper, a public meeting this month and, eventually, new rulemaking and guidance (The Gray Sheet’ Feb. 15, 2010).

FDA’s communications overhaul is part of the device center’s broader work to increase transparency, which is a strategic priority for 2010 (The Gray Sheet’ Jan. 25, 2010).

According to a priorities report issued in January, CDRH plans to implement a “strategic communication program” by the end of September.

– Jessica Bylander