Medical device design and regulatory

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Medical device design and regulatory essay assignment

Test P

­­­­­­­­­­­­­­­­1. Please identify the following information for a portable oxygen generator:

1. Product Code
2. Regulation Number
3. Recognized Consensus Standards
4. identify the concentration of oxygen supplied by the device and cite the 510(k) number where you identified the information.

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2. Please identify the most appropriate submission type for the following examples:
3. FDA approved a PMA for an excimer laser system for photorefractive keratectomy (PRK) for the reduction or elimination of myopia (nearsightedness). The PMA applicant modified the indication to add laser assisted in-situ keratomileusis (LASIK), a different procedure, for the reduction or elimination of myopia using the identical laser system. PRK uses laser ablation on the surface of the cornea to reshape it, whereas LASIK involves cutting a flap in the cornea and using laser ablation underneath the flap. The new indication involves a more invasive procedure with different risks associated with the creation, replacement, and maintenance of the flap. There were also new risks and clinical effectiveness concerns associated with the intrastomal ablation used in the new indication. These concerns include a different healing response, longer recovery times, different ablation profiles and deeper ablation into the cornea, potentially leaving it thinner, which may affect the physical integrity of the eye. Therefore, new clinical data were needed to demonstrate reasonable assurance of safety and effectiveness for the new indication for use. No preclinical testing was necessary because the device was not modified and the conditions of use remained the same.

1. FDA approved a ventricular assist device (VAD) intended as temporary mechanical circulatory support for patients awaiting a cardiac transplant. The applicant changed the design of the percutaneous ventricular lead in order to improve the interaction between the lead and the patient by making the lead more flexible and smaller in diameter. This design change was intended to reduce the physical damage to the lead at the site where it exits the patient. No change was made to the indication for use and the patient population. To demonstrate that the modified device remained safe and effective, only mechanical tests, such as pull/bend/twist testing were needed.

1. The PMA applicant of a vascular closure device submitted a 30-day notice to incorporate an alternate backup deployment test methodology in its manufacturing process.

1. The PMA applicant made a labeling change in the technical manual for its neurological implantable programmer, by adding a warning against using the device in the presence of any flammable anesthetic mixture in conformance with the FDA-recognized standard (i.e., International Electrotechnical Commission (IEC) 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Safety). This modification to the warning of the labeling enhanced safety with no impact on effectiveness.

1. The PMA applicant proposed to modify an excimer laser system by offering the wavefront system and the surgery planning software included in the original system as a stand-alone system to allow the surgeon to prepare for surgical cases in advance. There were no actual changes to the wavefront system or the surgery planning software, and both were included in the original PMA. Verification and validation of data transfer from the excimer laser system to the stand-alone system was sufficient to support this minor change. In addition, the supporting data for this change were within the single scientific discipline of electrical engineering.

1. FDA approved a PMA for a high frequency oscillatory ventilator (HFOV) indicated for ventilatory support and treatment of respiratory failure and barotrauma in low ventilatory support and treatment in adult patients with (adult) respiratory distress syndrome. The device itself was not modified. The patients in the original PMA consisted of infants with respiratory failure associated with lung immaturity, or other causes of respiratory failure in newborns. The new indication was for adults with adult respiratory distress syndrome, which is a condition associated with trauma and sepsis. Although both groups suffered from respiratory failure, the underlying lung pathology, the cause of the lung pathology, and the potential clinical outcomes for the two populations are different. Because of these clinical differences between these two patient populations, new clinical data were needed to evaluate the safety and effectiveness of the device in the new population. Since the device and the conditions of use remained the same, no new preclinical testing was necessary.

1. The PMA applicant updated the in-process test procedures to re-implement a back-up method for testing poppet pressure and pump flow rate. The primary test method uses an automated test procedure. This specific change re-implements the non-automated (mechanical) test method, to be used as an alternate method in the event that the automated method is off-line. The non-automated test evaluates the same performance characteristics as the automated test. Also, since the non-automated test was previously validated and incorporated in the pump manufacturing process, re-implementation of this change restores the manufacturing procedures to their previous state.

3. The review standard for a 510(k) is ___________________.
4. The review standard for a PMA is ____________________.
5. The review standard for an HDE is ____________________.
6. In the preamble to the Quality System Regulation, FDA discusses deleting the term hazard analysis and replacing it with a more comprehensive term. Please identify the comment number that discusses this issue and provide the more comprehensive term that was used in place of hazard analysis.
7. Identify the regulation number for the following:
8. purchasing controls
9. design controls
10. CAPA
11. complaint handling
12. A clinical study that is design to show that one treatment is better than another treatment is called a ______________ trial.
13. For a chronic heart failure trial that is evaluating the effects of a new cardiac resynchronous therapy pacemaker, rank the following endpoints from most scientifically rigorous to least.
14. HF Hospitalization
15. CV Hospitalization
16. CV Mortality
17. All-cause mortality
18. Dyspnea
19. Worsening NYHA Class without hospitalization
20. Recurrent hospitalization
21. Clinical composite score of 6MHW, NYHA Class and VO2_max
22. Minnesota Living with Heart Failure Questionnaire