In the Federal Register Notice the FDA said “The agency believes that this wil allow adequate time for interested persons to submit comments without significantly delaying action by the agency.”

Per a Mass Device web article of November 8, 2011 “The draft guidance is intended to update a 1977 guidance document, ‘Deciding When to Submit a 510(k) for a Change to an Existing 510(k).’ It aims to clarify when a new 510(k) pre-market notification should be submitted for a change or modification to a device that’s already won 510(k) clearance.”

On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information can be found on our blog post on this topic.

On March 4th  join Leo Eisner in Foster City, CA as he & several other presenters focus on the topic of “Evolving Risk-Based Regulatory Requirements” for a whole day workshop put on by RAPS (SF Bay Area Chapter) & ASQ (Biomedical Division Northern CA Discussion Group).  Leo will be presenting on the 3rd ed. of IEC 60601-1, the series of standards, and also the impact of change on the medical device industry.  Other topics will include Usability & Human Factors verification, validation, and regulatory requirements; and Clinical evaluation & investigation regulatory requirements. More information can be found on our blog post on this topic.

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