References
- FDA Device Definition. 1998 US Congress Federal Food, Drug, & Cosmetic Act Section 201(321), (1998).
- Mancini AJ. Skin. Pediatrics113(4 Suppl.), 114–1119 (2004).
- Hirsch BE, Blikas A, Whitaker M. Antibiotic prophylaxis in cochlear implant surgery. Laryngoscope117, 864–867 (2007).
- Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices. Pneumococcal vaccination for cochlear implant candidates and recipients: updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb. Mortal Wkly Rep.52, 739–740 (2003).
Websites
- Guidance for industry and FDA staff: Premarket Assessment of Pediatric Medical Devices. Issued May 14 (2004). www.fda.gov/cdrh/mdufma/guidance/1220.pdf
- FDA device advice premarket notification 510(k) www.fda.gov/cdrh/devadvice/314.html#intro
- FDA Device Advice Premarket Approval (PMA) www.fda.gov/cdrh/devadvice/pma
- Guidance for industry and FDA staff: medical device use safety: incorporating human factors engineering into risk management. www.fda.gov/cdrh/humfac/1497.pdf