Biomedical product classification

The EU and FDA approaches to a biomedical product classification have some differences. The European approach leaves some interpretation up to the manufacturer, who selects the classification based on the rules described in Directive 93/42/EEC and subsequent amendments, as well as a set of EU guidelines that help in the interpretation, but they do not have a binding nature. The FDA approach is more defined and provides a classification scheme that is more rigid but that probably guides the manufacturer more securely in the classification process. 

Classification of biomedical products made with bioabsorbable polymers... 

The existence of a borderline zone does not necessarily mean that there is a category of biomedical products that are neither MDs nor drugs it recognizes that there could be products whose classification is not immediately clear, and to proceed to a proper development of the product, these issues must be unraveled. 

These considerations may be applicable to biomedical products made with polymers. In particular, they apply to absorbable polymer products, wherein there could be doubts about the mechanism of action, which may influence the metabolism of the polymer. The basic requirement for the development of biomedical products made from resorbable polymers is therefore to clarify how the absorption of the polymer participates to achieve the pmpose of use of the product. This aspect is discriminative for the correct classification of the product as an MD or as a drug. 

Although the MEDDEVs and manual do not constitute rules with binding nature, these inputs should be taken into careful consideration in the classification of a biomedical product based on absorbable polymers, to determine whether they are drugs or MDs. 

Discrimination between drugs and MDs is based on the mechanism of action by which the product reaches the intended use. An initial approach for the proper development of a project on a biomedical product is to determine its proper classification. 

Part—I has three chapters that exclusively deal with General Aspects of pharmaceutical analysis. Chapter 1 focuses on the pharmaceutical chemicals and their respective purity and management. Critical information with regard to description of the finished product, sampling procedures, bioavailability, identification tests, physical constants and miscellaneous characteristics, such as ash values, loss on drying, clarity and color of solution, specific tests, limit tests of metallic and non-metallic impurities, limits of moisture content, volatile and non-volatile matter and lastly residue on ignition have also been dealt with. Each section provides adequate procedural details supported by ample typical examples from the Official Compendia. Chapter 2 embraces the theory and technique of quantitative analysis with specific emphasis on volumetric analysis, volumetric apparatus, their specifications, standardization and utility. It also includes biomedical analytical chemistry, colorimetric assays, theory and assay of biochemicals, such as urea, bilirubin, cholesterol and enzymatic assays, such as alkaline phosphatase, lactate dehydrogenase, salient features of radioimmunoassay and automated methods of chemical analysis. Chapter 3 provides special emphasis on errors in pharmaceutical analysis and their statistical validation. The first aspect is related to errors in pharmaceutical analysis and embodies classification of errors, accuracy, precision and makes... 

In a second generation of MEDLARS, which is planned for implementation this fall, it will be possible, with the aid of the data base established through the Chemical Abstracts registry system, to index biomedical publications with many more specific terms and chemicals than has been possible under MEDLARS I. While it is not projected that this extensive listing of chemical compounds be included in Index Medicus, it will be possible to provide such listings in other MEDLARS products. Thus a current publication of the Library, the Toxicology Bibliography, will list the biomedical literature by any desired chemical classification. 

---