Manufacturers of medical devices must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act). Under section 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for medical devices. This regulation became effective on December 18, 1978, and was codified under part 820 of the Code of Federal Regulations.
Of particular note is that the FDA considers medical device designers to manufacturers from a quality systems point of view. In light of this, all medical device designers should incorporate Design Controls into the medical device product development programs. Design controls include the following:
Design And Development Planning
Design Input
Design Output
Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design History File (DHF)
More detailed information Design Controls can be found at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm#_Toc382720784
FDA regulations require companies to immediately notify the agency when a company receives complaints of device malfunctions, serious injuries, or deaths associated with its medical devices. These adverse events are reported on what's called the Medwatch form, or 3500a.
Medical Device Reporting (http://www.fda.gov/cdrh/mdr/mdr-general.html)
MAUDE (Manufacturer and User Facility Device Experience) – searchable database http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM.
Research by Eliza Brannigan & Kristin Stiner
