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Benefits for aligning drug and device organizations, processes and governance models

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7 Keys to Successful Medical Device Development

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2nd Annual Drug/Device Combination Products Summit, December

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Create a Want Tell us what you're looking for and once a match is found, we'll inform you by e-mail. The Office is also responsible for designating the component of FDA with primary jurisdiction for the premarket review and regulation of any product requiring a jurisdictional designation.

Office of Combination Products. PMA applicants must demonstrate that the device is electrically safe and does not interfere with other devices used in the same environment. Electromagnetic compatibility, or EMC, means that the device is compatible with i. The wide variation of medical devices and use environments makes them vulnerable to different forms of electromagnetic energy which can cause electromagnetic interference.

CDRH accepts medical device applications in electronic form. PMA applicants should notify the reviewing division of CDRH of their desire to submit an application in electronic form prior to submission. This lead time is needed to discuss any special considerations with the submitter prior to development of the documents. This will assure that what a reviewer sees on the screen is the same as what would have been seen on paper.

At least one paper copy of the submission is also required. An electronic application does not change the order in which submissions are reviewed. No preferential treatment will be given to manufacturers who submit an electronic application.

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Additional copies of some reports may be requested in order to help facilitate the review. Additional information on electronic copies can be found the Internet. These devices compete for the same market with already approved devices of the same type and use, and therefore, there is no increased environmental impact resulting from the introduction of the device into commercial distribution.

A statement requesting a categorical exclusion under sections If the device causes environmental hazards in the manufacture, use, or disposal of the device, an environmental assessment must be submitted in the PMA.

Other devices are not required to have expiration dating, but may be appropriate. If expiration dating is provided in the labeling, it must be based upon the storage instructions provided in the labeling and substantiated through stability testing. Information about shelf life may be found:. In vitro diagnostics are medical devices that analyze human body fluids, such as blood or urine, to provide information for the diagnosis, prevention, or treatment of a disease. This law established quality standards for laboratory testing and an accreditation program for clinical laboratories.

The requirements that apply vary according to the technical complexity in the testing process and risk of harm in reporting erroneous results. The regulations established three categories of testing on the basis of the complexity of the testing methodology: waived tests, tests of moderate complexity, and tests of high complexity. Reference Materials.

U.S. Food and Drug Administration

Local Tissue Tolerance. Dermal irritation. Ocular irritation testing. Other Nonparenteral Route Irritation Tests. Parental Routes.

Intracutaneous Irritation. Problems in Testing and Their Resolutions. Overview of the Immune System. Evaluation of the Immune System. Local Lymph Node Assay. Problems and Future Directions. Implantation Biology and Studies. USP implantation Test. ISO Implantation Test. Test Method for Implantation in Subcutaneous Tissue. Test Method for Implantation in Muscle. Test Method for Implantation in Bone. Controls Materials. Long-term Implant Studies. Acute Systemic Testing. DNA structure. In Vitro Cytogenetic Assays. In Vivo Cytogenetic Assays. Sister Chromatid Exchange Assays.

Regulatory considerations. Parameters to measure.