Medical devices drug-device combinations

Commission Directive 95/45/EC, July 26, 1995, laying down specific purity criteria concerning colors for use in foodstuffs. Off. J. Eur. Commun., L226, 22.09.1995. U.S. Food Drug Administration, Summary of color additives listed for use in the United States in food, drugs, cosmetics and medical devices, Washington, D.C., 1999. JECFA, online edition. Combined compendium of food additive specifications, http //WWW. fao. org. 

Health Canada is the responsible Ministry for the enforcement of the Food and Drugs Act and for the formulation of and amendments to the Drugs Regulations. The former Drugs Directorate and the Medical Devices Bureau of the Health Protection Branch (HPB) have been combined to form a new agency, the Therapeutic Products Programme (TPP). 

The multichambered autoinjector is simply a device that will allow a nerve agent victim to administer both the atropine and the 2-PAM through a single needle. This medical device is also FDA-regulated and while each of the drugs contained in the device is approved separately, the combination delivery system requires additional FDA testing. Both of these products have spent at least a decade in development but are not expected to be fielded during the next several years. 

The Medical Device Directive 93/42 defines medical devices and products, which combine a drug with a device. For regulatory purposes, the latter are subdivided and dealt with as follows ... 

In 1992 Gleb sold off the Drackett household-goods business to S. C. Johnson Sons for 1.5 billion. But despite predictions in the business press of Bristol-Myers Squibb s sale of its OTC drug and nutritional lines (with a combined value of 6.1 billion) and of its toiletries and beauty aids (valued at 2.5 billion), the company continued to maintain these lines. So in 1994, 75 percent of sales derived from pharmaceuticals, divided as follows 58 from prescription drugs, and 17 from consumer health products. Of the remaining 25 percent of sales, 14 percent came from medical devices, and 11 percent from toiletries and beauty aids. 

The immediate impact of a device on the body is more evident than that of a drug. Effects are often observed within hours or days. Therefore, the risks are front-loaded and device efficacy is more easily measured. When registries are maintained it is possible to track longer term use and outcomes of a medical device. Postmarket surveillance of drugs is difficult due to variables in prescribing, patient adherence, and use in combination with other medicines. 

To address these concerns, a new OCP was created on December 24, 2002 as part of the Medical Device User Fee and Modernization Act (MDUFMA) of 2002 [8. Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 3. Assignment of Agency Component for Review of Premarket Applications. Final rule. Federal Register. Vol. 68, No. 120, Monday, June 23, 2003 http //www.fda.gov/oc/ combination/section204.html (accessed October 2005).]... 

Inhalants are drugs or combinations of drugs that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect. The device in which the medication (s) is contained and from which it is administered is called an inhaler (e.g., Vicks Inhaler Benzedrex Inhaler). 

Other categories of medical devices include combination devices, in which a device may incorporate drugs or biologicals. Combination devices are controlled via intercenter arrangements implemented by the FDA. 

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