RPM Chapter 9, Subchapter Import for Export
...7 on form FDA 2877 needs to be checked to indicate that the device is for medical device processing under import.....The import also must comply with all applicable export requirements when the product is.....Districts should reconcile the quantities provided and any product not accounted for..
http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9impex.html (score=100)

Document
...As for batches of the same product, objected to the proposed requirement, or offered for.....type of device if the product is a device, exporter first ships a drug or device to.. example, assume that company X.....article's type if the product is a device, discussed in greater detail in the.. valid marketing..
http://www.fda.gov/OHRMS/DOCKETS/98fr/121901a.pdf (score=21)

ANNUAL REPORT TO CONGRESS
...This includes requests for classification of a product as a biological product, device or drug, as well as requests for.....drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or.....Product specific issues involved a diverse array of combination products in product areas..
http://www.fda.gov/oc/combination/congressreport.html (score=21)

DDPA January 1996
...MODIFICATION OF 01/24/96 22-CHANNEL ENGLEWOOD, CO THERAPEUTIC CLAIMS OF COCHLEAR 80112.....Product Available Generically 64-047 NEOMYCIN AND BAUSCH AND LOMB GRAMICIDIN 31-JAN-96.....DISTRIBUTION OF DEVICE BY 01/02/96 MODEL C1OUB CLAREMONT, CA ALLERGAN MEDICAL OPTICS..
http://www.fda.gov/cder/da/ddpa196.htm (score=21)

G:\RES\SGML\OC02197.XML
...evaluate the effectiveness of the product for a particular indication in patients .. with.....of the study; (2) there is an adequate supply of the product/device; and (3) there is continued.....device exemption (IDE) procedures. Studies of approved products to evaluate .. new orphan..
http://www.fda.gov/orphan/grants/FY2003RFA.pdf (score=21)

WAIS Document Retrieval
...Once CBER has approved a request for determination, future shipments of the same product.....product, device, food, food additive, color additive, or dietary supplement that will be exported.....product, device, food, food additive, color additive, or dietary supplement in the United States..
http://www.fda.gov/cber/genadmin/frimpexp.txt (score=21)

FR Doc 05-762
...The title of the proposed study must include the name of the product and the disease.....Applicants studying an NSR device should provide a letter in the application from the FDA.....If negotiations with a sponsor to supply the study product are underway but have not been..
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-762.htm (score=21)

...A priority countermeasure that is a drug or biological product shall be considered a.....product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that the Secretary.....product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that is a priority under..
http://www.fda.gov/oc/bioterrorism/PL107-188.html (score=21)

...Product Available Generically 40-069 DEXAMETHASONE SODIUM BAUSCH AND LOMB DEXAMETHASONE.....DEVICE BERKELEY, CA DIRECTIONS FOR USE (VAD) SYSTEM 94710-2090 P880003/S060 CORDIS PTCA.....When the application receives final approval, the product may be legally marketed. The..
http://www.fda.gov/cder/da/ddpa796.htm (score=21)

Guidance for Industry: Source Animal, Product, Preclinical, and Clinical...
...Conditions of normal physiologic use of the xenotransplantation product/device combination product.....In summary, you should design animal studies of xenotransplantation product/device combinations.....Master Files are submitted to FDA and contain information regarding a product, such as product manufacture..
http://www.fda.gov/cber/gdlns/clinxeno.htm (score=21)

Exports: Notification and Recordkeeping Requirements
...As for batches of the same product, objected to the proposed requirement, or offered for.....type of device if the product is a device, exporter first ships a drug or device to.. example, assume that company X.....article's type if the product is a device, discussed in greater detail in the.. valid marketing..
http://www.fda.gov/cber/rules/exportnotif.pdf (score=21)

April 1998 News Along the Pike
...Research, or if the product appears to be a combination drug/Correcting the misdesignation.....sponsors often submit the product for review as a device and.. products belong rests with the Agency's Ombudsman.....sponsors prefer device status to avoid user fees and to be subject.. Jim Morrison is the..
http://www.fda.gov/cder/pike/april98.pdf (score=21)

FR Doc 05-16527
...CDER Though the product has a device mode of action, the product's primary mode of action is.....Another action of the product is the device component's action to provide a scaffold on which the new.....A drug-device combination product with a device PMOA, where the device is regulated by CBER, would be..
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-16527.htm (score=21)

DDPA April 1995
...When the application receives final approval, the product may be legally marketed. The.....product has expired. Final approval is also contingent upon conditions and information.....DEVICE - PREMARKET APPROVAL APPLICATIONS*** THE FOLLOWING DATA IS RECEIVED FROM THE CENTER..
http://www.fda.gov/cder/da/ddpa495.htm (score=21)

DDPA February 1995
...When the application receives final approval, the product may be legally marketed. The.....DEVICE AS 02/23/95 CORONARY BALLOON CORPORATION MODIFIED WILL BE DILATATION WATERTOWN, MA.....product has expired. Final approval is also contingent upon conditions and information..
http://www.fda.gov/cder/da/ddpa295.htm (score=21)

Chapter VIII - Imports and Exports
...When an exporter of a drug or device first begins to export a drug or device to a country.....product, device, food, food additive, color additive, or dietary supplement that will be.....product in bulk form, shall be excluded from importation into the United States under..
http://www.fda.gov/opacom/laws/fdcact/fdcact8.htm (score=21)

DDPA October 1995
...REDUCED DEVICE 10/31/95 THERA-I/PRODIGY MINNEAPOLIS, MN SIZE FOR THERA DR PULSE GENERATORS.....Product Available Generically 64-055 NEOMYCIN SULFATE AND BAUSCH AND LOMB DEXAMETHASONE.....When the application receives final approval, the product may be legally marketed. The..
http://www.fda.gov/cder/da/ddpa1095.htm (score=21)

G:\RES\EADOCS\PDFFIL~1\COPIES~1\OC03366.XML
...For some products, though, the PMOA of the product is not readily apparent, to either FDA.....drug/device, biological product/device, drug/ biological product, or drug/device/biological product, that are.....are comprised of more than one type of regulated article (biological product, device, or..
http://www.fda.gov/OHRMS/DOCKETS/98fr/oc03366.pdf (score=21)

...offered for sale in domestic commerce, biological product; would not have access to the.....the device is a nonsignificant risk device, and.. 9 Unlicensed biologics that fail to.....not object to the product's marketing, in accordance with the product's.. without an..
http://www.fda.gov/cber/gdlns/exportdft.pdf (score=21)

Document
...360c­360f, 360h­360j, 360gg­360ss, product has a device mode of action, the present similar safety and.....is the first such combination product, or action makes the greatest contribution to is.....of device contained in section 201(h)(1) there are no other combination products William K..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-10447.pdf (score=21)

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