Making sense of the food and drug administration
| Autor: | Jessica Anne Connor |
|---|---|
| Rok vydání: | 2006 |
| Předmět: |
medicine.medical_specialty
Active involvement Process (engineering) Surgical Equipment Food and drug administration medicine Device Approval Humans Obligation Adverse effect Child Equipment Safety business.industry United States Food and Drug Administration Equipment Design medicine.disease Surgical Instruments Altruism United States Surgery Pediatric patient Regulatory control Pediatrics Perinatology and Child Health New product development Medical emergency business |
| Zdroj: | Seminars in pediatric surgery. 15(4) |
| ISSN: | 1055-8586 |
| Popis: | An examination of and recommendations regarding the approval process for medical devices are presented. The typical pathways and hurdles laid out by the Federal Food and Drug Administration (FDA) are discussed, and options for marketing and use of medical devices are addressed. The first step in the regulatory process is to establish that the new product is, in fact, a medical device. From there, the appropriate classification and the corresponding level of regulatory control that will be required can be identified. The appropriate marketing application will be submitted and is supported by the data necessary to reasonably assure safety and effectiveness. Once the application is submitted, reviewed, and eventually approved, the manufacturer may legally market and sell the medical device. The active involvement of physicians as advisors and innovators in medical device development is imperative to the successful development of safe and effective medical devices. Physicians also fulfill the important obligation of adverse event reporting with all medical devices that they use. The pediatric physician should additionally be aware of the FDA regulations and expectations with respect to devices that will serve pediatric patient populations, of the regulatory options for approval and unapproved use for some devices, and of the special measures taken to protect the rights, safety, and welfare of pediatric patients participating in investigational studies. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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