FDA 510(k) Approval - Methodsense, Inc

June 24, 2019
By Russ King
FDA Compliance, Medical Devices, Risk Management

Accessory or Component and the FDA – The Fine Line Between Them

Determining if your product or innovation should be considered a component or an accessory is a critical early-life cycle inflection point. In fact, the distinction between the two terms has long been the subject of debate and interpretation. In August 2017, the FDA began a new effort to classify a “list of [medical device] accessories...

March 28, 2017
By Rita King
Human Factors, IEC 62366

10 Things You need to know about Human Factors Validation

As medical devices become more complex, the FDA will continue to place greater emphasis on ways to improve safety and effectiveness before products are commercialized. One relatively recent method is Human Factors Engineering, also known as Usability Engineering, which is used to identify and mitigate use errors. Of course, this can place additional burdens on...

September 7, 2015
By Rita King
FDA Compliance, Medical Devices

Software and the FDA Refuse to Accept Policy for 510(k)s 2015 Guidance

The path to medical device commercialization requires FDA clearance, which most often means filing a pre-marketing notification, also known as a 510(k). The FDA has specific criteria for accepting a 510(k), and they just released their new acceptance policy. This new standard, which will be effective October 1, 2015, replaces the old FDA Refuse to...

Don’t Forget Safety Testing and the Value of Risk Management!

Establish the Safety of Your Medical Device with IEC 60601 Compliance In our experience, the most frequently forgotten aspect of medical device development and commercialization from emerging companies is establishing a safety profile of a product. While clinical data or clinical trials may be necessary for establishing safety for some products, many Class II devices...

Tag: FDA 510(k) Approval

Accessory or Component and the FDA – The Fine Line Between Them

10 Things You need to know about Human Factors Validation

Software and the FDA Refuse to Accept Policy for 510(k)s 2015 Guidance

Don’t Forget Safety Testing and the Value of Risk Management!