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U.S. Department of Health and Human Services

About FDA

Use of portable scientific applications to assist in regulatory decisions earlier in the supply chain

Description: Identify and develop analytical tests, test applications, special techniques and laboratory space to deploy outside of the traditional laboratory sites in order to provide an assessment of the compliance status of a product or process in an expedited manner.

Accomplishment: ORA has completed the key project, “Use of Portable Scientific Applications to Assist in Regulatory Decisions Earlier in the Supply Chain”. This project evaluated four handheld devices to assess the compliance status of FDA regulated products in an expedited manner at the site of product importation. The four devices evaluated were: X-Ray Fluorescence (XRF), Ion-Mobility Spectrometry (IMS), Raman-Spectrometry (RS), and Near Infrared Spectroscopy (NIR). The benefits of portable screening include rapid examination in the field, at the product import site, allowing the release of non-violative samples screening negative without further detention or examination. This provides the ability to focus FDA collection and laboratory resources on potentially violative samples screening positive. Samples collected and analyzed in ORA laboratories provide better accuracy, sensitivity and selectivity than the portable screening devices, but sample collection and testing are more costly and time consuming.

IMS, RS and NIR use spectral libraries to detect targeted APIs, as well as excipient and API adulteration. IMS assignments were issued to detect weight loss drugs in dietary supplements. RS and NIR assignments were issued to detect contaminants in raw materials. XRF can be used to detect a wide range of elements especially toxic element contamination. An XRF assignment was issued to detect toxic metals in dietary supplements.

Briefing Status: Completed

Prior Briefing Status: On Track

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Develop/identify analytical tools and techniques for forward deployment to the field to focus on sampling activities

N/A

Completed 1/1/2010

2. Validate and qualify X-Ray Fluorescence device (XRF). (XRF is a handheld device used to detect low level elements in food and drug products.)

N/A

Completed 3/26/2010

a. Establish requirements for deployment to the field of XRF

5/31/2010

Completed 5/31/2010

b. Conduct training and issue XRF of investigators on use of XRF

7/15/2010

Completed 7/15/2010

c. Issue XRF assignment to the field

9/1/2010

Completed 9/1/2010

d. Assess results of XRF assignment, field feedback and analytical findings for determination of possible modifications

11/1/2010

Completed 2/4/2011

3. Validate and qualify Ion Mobility Spectroscopy device (IMS). (IMS is a handheld device technology based on molecular mass used to analyze herbal and "natural" products for the presence of sibutramine and fluoxetine.)

N/A

Completed 3/26/2010

a. Establish requirements for deployment to the field of IMS

9/30/2010

Completed 9/30/2010

b. Conduct training and issue IMS of investigators on use of IMS

11/15/2010

Completed 12/15/2010

c. Issue IMS assignment to the field

1/1/2011

Completed 2/11/2011

d. Assess results of IMS assignment, field feedback and analytical findings for determination of possible modifications

3/1/2011

11/1/2011

9/28/2012

2/28/2013

Completed 3/8/2013

4. Validate and qualify Raman. (Raman is a handheld device technology based on unique symmetrical atomic bond vibrations used to detect diethylene glycol (DEG) in glycerin and ethylene glycol (EG) in sorbitol.)

N/A

Completed 3/26/2010

a. Establish requirements for deployment to the field of Raman

1/31/2011

Completed 3/25/2011

b. Conduct training and issue Raman to investigators

3/15/2011

Completed 9/10/2011

c. Issue Raman assignment to the field

6/1/2011

Completed 9/19/2011

d. Assess results of Raman assignment, field feedback and analytical findings for determination of possible modifications

8/1/2011

1/15/2012

11/1/2012

4/30/2013

Completed 5/14/2013

5. Validate and qualify Near InfraRed Spectroscopy device (NIR). (NIR is a handheld device technology based on unique asymmetrical atomic bond vibrations used to detect diethylene glycol (DEG) in propylene glycol and melamine in lactose.)

N/A

Completed 3/26/2010

a. Establish requirements for deployment to the field of NIR

6/30/2011

Completed 9/2/2011

b. Conduct training and issue NIR to investigators

8/15/2011 10/24-11/10/2011

Completed 2/10/2012

c. NIR assignment to the field

10/1/2011 11/7/2011

Completed 5/30/2012

d. Assess results of NIR assignment, field feedback and analytical findings for determination of possible modifications

12/1/2011

2/20/2012

10/1/2012

6/30/2013

Completed 6/30/2013

6. Deploy mobile laboratories to growing, harvesting, processing and manufacturing sites for expedited analysis of samples

9/30/2010

Completed 9/30/2010

7. Identify critical border sites for establishment of satellite laboratories

9/30/2010

Completed 9/30/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.