Interested in improving the FDA 510(k) system?

M

MIREGMGR

#1
Those of you who might want to formulate your dissatisfactions with the present 510(k) system into justified suggestions for improvement, may want to know about a new FDA improvement project, "Strengthening the Center for Devices and Radiological Health's 510(k) Review Process.''

The announcement is here.

A public meeting will be held in the metro Washington DC area on February 18th. Comments by mail or email will be accepted until March 5th. Section III of the announcement has a long list of substantive discussion proposals.

Obviously there's a high level of awareness at FDA of some of the issues involved, and a willingness to consider changes. This is an opportunity to present substantial proposals to those who...if they agree as to merit...could greenlight them.
 
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Michael Malis

Quite Involved in Discussions
#2
Those of you who might want to formulate your dissatisfactions with the present 510(k) system into justified suggestions for improvement, may want to know about a new FDA improvement project, "Strengthening the Center for Devices and Radiological Health's 510(k) Review Process.''

The announcement is here.

A public meeting will be held in the metro Washington DC area on February 18th. Comments by mail or email will be accepted until March 5th. Section III of the announcement has a long list of substantive discussion proposals.

Obviously there's a high level of awareness at FDA of some of the issues involved, and a willingness to consider changes. This is an opportunity to present substantial proposals to those who...if they agree as to merit...could greenlight them.
Be careful what you wish for!
For my end of the industry, there is nothing wrong with the existing process...
Yes, - we all want "shorter review time", however we already have a very stringent review process. When politics get involved - the process have a chance to get worse, not better!
 
M

MIREGMGR

#3
I don't see a basis for assuming that specific regulatory changes would be influenced through the political aspects of the governmental process, given that:

1. The process for requesting input goes no higher than FDA senior management.
2. The FDA's history is substantially free of such micromanagement by the legislative branch, or the executive branch above HHS, in the device realm. (Though admittedly, such issues have existed on the pharma side.)

In any case, the change-process is already committed and under way. I don't see a downside in participating so as to represent what I consider to be desirable views, in order to avoid an outcome where the only participants hold very different and problematic views and those views are adopted due to lack of balancing input.

My comments will be focused on:

1. The FDA's device classification system. In general, I regard the MDD classification system as just as protective and much easier to manage.

2. Inspections/audits, and FDA operational costs. I'd prefer that the FDA require device makers to contract with a licensed auditor-organization (akin to an ISO 13485 NB, but legally responsible/bonded to take into account the FDA's legal role) for semi-annual certification per a QSIT 1 audit, with the FDA's own resources dedicated only to QSIT 2 audits and above, plus NB supervision. I'd envision such certification costs as being based on the device maker's product classification scope and thus risk extent.
 

Michael Malis

Quite Involved in Discussions
#4
The registration for the February 18 FDA 510(k) meeting is closed.

Many people were denied attendance.
AdvaMed will have a conference room in the AdvaMed offices reserved for viewing the meeting.

Written comments will be prepared in response to the questions posed in the FR notice for the 510(k) meeting.
 

bio_subbu

Super Moderator
#5
The presentation on Strengthening the Center for Devices and Radiological Health’s 510(k) review process is available for download. The presentation covers issues related to predicate devices, issues related to new technologies and scientific evidence, issues related to different type of submission such as bundled, 3rd Party and submission which contain standards, issues related to post market surveillance and new information about marketed devices. A copy of presentation can be downloaded here.

Regards
S. Subramaniam
 

Attachments

C

Crimson

#7
Saw an interesting presentation on the 510k review process at the recent Medical Device Summit in Boston - a good resource (blog) for conversation was started by a software engineer at Philips (Brad Ryba): http://my510k.com/
 
L

LeeFu

#8
I hope FDA can release uniform and tranparent review criteria.

I alway encounted different deficiencies from different reviewer for same product, and some problems were criticle.
 
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