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Notes on FDA Website Redesign from Dr. H. Neal Dunning
September, 2009
FDA (actually the HHS department) has "improved" the FDA website we have found so useful in the past.
This improved site is accompanied by several disadvantages.
The main FDA site is www.fda.gov. The page looks interesting, but if you hit "print page"
you can get five pages of redundant content.
But important is a group at the top of the left column which lists the main types of products FDA regulates.
For interest in medical devices, click on (select) "Medical Devices".
The direct address: www.fda.gov/MedicalDevices.
On the Medical Devices page, most material is accessed by clicking on "Device Advice: Device Regulation and Guidance".
But try going to a commonly accessed prompt under the "Tools and Resources" heading about half-way down on the right column and
select "Device Registration and Listing".
When you reach this page, look at the upper left column and you can select any of several headings to get a wealth of information
(and perhaps get your questions answered). The instructions are well done.
Medical Devices (main page)
Device Advice: Device Regulation and Guidance
How to Market Your Device
Medical Device Registration and Listing
Important Reminders about Registration and Listing
Access Electronic Registration
Who Must Register, List and Pay the Fee
When to Register and List
How to Register and List
Payment Process
U.S. Agents
Documents
Search Registration and Listing
Contact Us
Speaking of education, there is a big addition to the devices web material.
On the medical devices home page, under "Industry Assistance" (lower part, center column) select "CDRH Learn".
On this page is a description of DSMICA’s latest educational effort. It says, "CDRH Learn is our latest innovative educational tool.
It consists of a series of training modules describing many aspects of medical device and radiological health regulation, covering both
premarket and post–market issues.
This tool is intended to provide the medical device and radiological health industry with an information resource that is comprehensive,
interactive and easily accessible."
If you move to the top left column, you will be able to select a video from the following "Course List".
Skipping the first nine BIMO (Biological Research Monitoring) subjects, videos include presentations by FDA experts in the subjects listed below:
Overview of Regulatory Requirements: Medical Devices (Bill Sutton, Dep. Dir. DSMICA)
Quality System Regulation 21 CFR 820 Basic Introduction (Kim Trautman, QS Expert)
Overview of the Premarket Notification Process – 510(k) (Heather Rosecrans, Dir. 510(k)s
Product Codes, Making the Connection... (Brandi Stuart, Product code coordinator)
- 510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k) (Marjorie Shulman, Admin. 510(k) prog.)
- 510(k) User Fees (Marjorie Shulman, Admin. 510(k) prog.)
- 510(k) Third Party Review (Eric Rechin, Policy Analyst)
- "513(g)s".. Including 513(g) User Fees (Lawrence Romanell, Network Leader)
Device Establishment Registration and Listing (David Racine, Capt)
How to Get Your Electronic Product on the U.S. Market (Sean Boyd, CDR)
Future Course Topics
Medical Device Reporting (MDR)
Advanced Quality Systems
A major medical device subject of interest is Premarket Notification—510(k)s.
From the Medical Device main page, go to "Tools and Resources" (middle, right column), move down and
select "Medical Device Databases". This looks like the database page we have used before!
It is valuable because you can drop down to (e.g.) Premarket Notifications, click, and find the usual 510(k) search template.
Or select the Classification Data Base, click and (perhaps) find the classification data on the device of interest.
Then you can go back, put this "code" in the proper place on the 510(k) search template and find who has
been clearing that particular device for marketing.
The "code" is also a basic requirement for listing your device.
These are some examples of the new FDA web site.
Export and import materials are now at www.fda.gov/MedicalDevices/DeviceRegulationandGuidance.
When on this page, select "Importing and Exporting Devices" from the menu at the left side.
This page allows selection of the materials on procedures and costs for obtaining a
Certificate of Exportability or Certificate to a Foreign Government, and now contains information
regarding the import of medical devices as well.
Alternately, this material may be reached by going to the medical devices home page:
www.fda.gov/MedicalDevices,
then selecting "Device Advice: Device Regulation and Guidance"
(near mid-page, to the left); now select "Importing and Exporting Devices" as above.
Note: FDA has consolidated their offices at the White Oaks Center in north Silver Springs, MD. Their phone numbers have all changed.
The Divisional Offices can be
found at:
www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm154052.htm
For example, the Division of Anesthesiology, General Hospital, Infection Control and Dental Devices is 301-796-5580.
DSMICA is 301-796-5680 or 800-638-2041.
Note for surfers: The "Search" box in the upper right hand corner of the Medical Devices (or the FDA) webpage is very useful for
topics which are not specific to a listed area.
From the desk of Dr. H. Neal Dunning
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Regulatory