Eisner Safety Consultants» 510(k)

FDA Extends Comment Period on 510(k) Guidance

leoeisner — Mon, 14 Nov 2011 06:18:23 +0000

On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October 25, 2011 to November 28, 2011.

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Per a Mass Device web article of November 8, 2011 “The draft guidance is intended to update a 1977 guidance document, ‘Deciding When to Submit a 510(k) for a Change to an Existing 510(k).’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.”

FDA Updates 515 Prog. Initiative Webpage (reclassified preAmend Class III 510(k)s)

leoeisner — Wed, 19 Jan 2011 17:54:56 +0000

The FDA updated the 515 program initiative webpage also known as reclassification of preAmendment Class III 510(k)s. Currently there are 26 Class III products going thru the 515 program initiative and you can view the status of the 515 project.

FDA Modifications to List of Recognized Standards, List 025

leoeisner — Tue, 26 Oct 2010 20:00:31 +0000

On Oct 4, 2010 the Federal Register published the “Modifications to the List of Recognized Standards, Recognition List Number: 025“. This list will assist medical device manufacturers who elect to declare conformity with FDA Consensus Standards to meet certain FDA requirements for medical devices.

You can view the current & previous lists which shows all the Fed Reg publications of the Lists. The best way to use this system of Recognized Standards List is to access the Database.

Stricter 510(k) Process Offers Challenges, Promises

leoeisner — Wed, 20 Oct 2010 17:36:24 +0000

From MDDI Magazine – Sept 2010 – “FDA has released its long-awaited plans to shore up the 510(k) clearance system used to get many medical devices to market. In August, the agency published a 120-page report to define which devices are appropriate for the approval pathway and when those applications would require additional evidence of both safety and efficacy. These recommendations will be open for public comment.” To read the whole story click here.

Later in the article there are Highlights of Proposed Changes to 510(k)

How Comment on FDA CDRH FY11 Draft Guidance Documents?

leoeisner — Tue, 05 Oct 2010 23:42:01 +0000

How to comment on FDA CDRH FY11 Draft Guidance Documents? http://ht.ly/2OiXg

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

CDRH Webinar re: 2 rprts: #510(k) proc & use of Sci in decision making process

eisnersafety — Fri, 27 Aug 2010 16:09:19 +0000

CDRH Webinar to discuss 2 reports: 510(k) premarket review process and the use of science in CDRH’s regulatory decision making process to respond to questions & concerns will be on 31-Aug-10 http://ht.ly/2vNw7

Just Say No to FDA’s Idea of Transparency? MD&DI

eisnersafety — Fri, 20 Aug 2010 00:09:36 +0000

Just Say No to FDA’s Idea of Transparency from MD&DI Magazine Aug-10 http://ht.ly/2sa6c See our post FDA Issue Assessment of 510(k) for the FDA assessment report on the 510(k) process

FDA Issues Assessments of 510(k) Process & Use of Science in Decision-Making

eisnersafety — Fri, 06 Aug 2010 20:53:06 +0000

FDA Issues Assessments of 510(k) Process & Use of Science in Decision-Making http://ht.ly/2mcXz

FDA 510(k) Process Under Microscope – So. Cal Presentation

eisnersafety — Thu, 22 Jul 2010 17:41:02 +0000

FDA 510(k) Process Under the Microscope: How Will Changes Impact You? – Newport Beach, Ca 7/29/10 CA Healthcare Institute http://ht.ly/2fbvs

Draft FDA Guidance – Infusion Pumps – Total Product Life Cycle – Premarket Notification [510(k)] Submissions

eisnersafety — Wed, 28 Apr 2010 17:52:38 +0000

Draft FDA Guidance – Infusion Pumps – Total Product Life Cycle – Premarket Notification [510(k)] Submissions http://ow.ly/1EjNL

FDA 510(k) process Meeting of 2/18/10

leoeisner — Fri, 19 Feb 2010 18:45:04 +0000

FDA staff say agency may need new device powers

Reuters on 2/18/10 wrote about the well attended meeting by industry representatives.