FDA Approves New Device - Screens for Melanoma

• Trusted FDA CGMP online training courses and programs by SkillsPlus International Inc.

Image via WikipediaUpdated 9/6/2013:

The original link broke.

You can still read about the same topic here:

New device uses light to screen for melanoma - NBC News

- - - - -

The Associated Press: New device uses light to screen for melanoma:    'via Blog this'

"The Food and Drug Administration (FDA) approved a first-of-its-kind device, called MelaFind, that makes detailed, digital images of skin growths and uses a computer to analyze them for signs of cancer, offering a sort of second opinion to doctors. The device is approved only for dermatologists and only for use on growths that don't have obvious signs of cancer but still have one or two worrisome traits."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA - PREDICT - Imported Food and Drug Safety Tool

Updated September 20, 2023

The original link/video broke.

You can still read about the same topic here:

Entry Screening Systems and Tools - FDA.gov

---  the original post follows below  ---

The FDA announced the launch of a new risk-assessment tool to ensure the safety of imported food and drugs. The web-based PREDICT system will rank the risk hazards of food and drugs as they enter the country and allow inspectors to focus on the most likely threats to public health.

PREDICT uses a scoring system that determines the risk level of the imported products. Under the new system, shipments would be flagged for additional screening on a score that is based on their country of origin, manufacturers' safety records and their contents. The program is scheduled to first be implemented in New York.

Return Home: http://drughealth.blogspot.com/

2010 - Border inspections and delays for device and import - more FDA presence

Image via Wikipedia

Updated October 15, 2016

You might also be interested in:
What to Expect Now that the First Big FSMA Compliance Dates Are Here

- -  original post follows below  - -

Devicemakers and importers can expect delays for inspections and screenings because the FDA is putting their trainees at US borders, reports FDAnews Device Daily Bulletin, Devicemakers May Face More Inspections, Delays in 2010:

"New employees probably will be trained at the borders because that’s where the highest volume of regulated commodities can be found"

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

FDA Approves First New Nucleic Acid HIV Test

Updated September 25, 2023

The original link broke.

You might also be interested in:

HIV Home Test Kits - FDA.gov

---  the original post follows below  ---

This just in. The FDA approved a new HIV blood test that screens for two uncommon strains of the virus recently detected in the U.S. The news release reports, FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue. This is important for a couple of reasons . . .

• The test can simultaneously detect HIV-2 and HIV-1 Group O strains. Both types of HIV are mainly found among patients in Africa, but the FDA said they have recently been detected in the U.S.
• It provides better protection for patients

FDA 510(k) Free Tips And Pearls Of Wisdom

Updated July 6, 2023

The original links broke.

You might also be interested in:

510(k) Clearances - FDA.gov

---  the original post follows below  ---

If you're working on a 510(k) medical device submission, you might want to peek at this Medical Device Blog post that's full of great tips for avoiding heartaches, "510(k) Approval Timeline." There's some really good stuff there. Did you find those tips helpful? If you need more info, try the FDA's own site . . . The FDA's Information on Releasable 510(k)s: General Information Federal Register Notices Search the Releasable 510(k) Database Listing of CDRH Substantially Equivalent (SE) 510(k) Summaries or 510(k) Statements, for Final Decisions Rendered Downloadable 510(k) Files One gem is the FDA's "SCREENING CHECKLIST - ALL PREMARKET NOTIFICATION [510(k)] SUBMISSIONS" (free) that's used to assess whether your paperwork is complete enough or not for a substantive review. 

Previous 510(k) Posts: Medical Devices - A murky 510(k) world?! Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending 

Return Home: http://drughealth.blogspot.com/