Get Medical Device Inspection Applications

Routine inspections, also called surveillance inspections, generally happen every two years. The FDA is required by law to inspect Class II and Class III medical devices every two years. GMP regulations can and do frequently change to reflect the current regulatory climate.

The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application, or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process.

Routine Inspections are mandated by law every 2 years for class II and class III device manufacturers. They follow a prescribed method known as Quality System Inspection Technique (QSIT), which will be discussed later in the article.

Make FDA Inspection Procedures Clear & Concise. ... Make Key Documents & Records Easily Accessible in an Inspection-Ready Binder. ... Label Items for Fast Retrieval. ... Compile Product Complaints & CAPAs Since Your Last Inspection. ... Report All Corrections/Recalls & Keep Documentation Current.

Devices@FDA provides one place where you can find official information about FDA cleared and approved medical devices. You can use Devices@FDA to: Find out if and when medical devices were cleared or approved by FDA. Read summaries of medical devices currently on the market.

Adulteration. Medical devices are subject to the adulteration provisions of the FD&C Act under Section 501. ... A device is held to be adulterated if it includes any filthy, putrid, or decomposed substance, or if it is prepared, packed, or held under unsanitary conditions.

Risk analysis: Inspectors will want to see that you've put any and all appropriate risk monitoring systems in place and that you're routinely assessing relevant risks within your operations. Product recall and rejection reports. Equipment and instrumentation calibration and maintenance reports.

Devices@FDA provides one place where you can find official information about FDA cleared and approved medical devices. You can use Devices@FDA to: Find out if and when medical devices were cleared or approved by FDA. Read summaries of medical devices currently on the market.