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

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 that the Agency believes are suitable for distinct classification into class I.”  However, this effort lead to even more questions and less understanding between the classification designations and the actual device. Let’s try to break this down to help with the clarification process: What does the FDA consider an accessory versus a component?An accessory is intended to support, supplement, and/or augment the performance of one or more devices, often called “parent devices”. It is considered a finished device—meaning it is ready for use or capable of functioning.A component (in 21CFR 820.3) is defined as “…any raw material, substance, piece, part, software, firmware, labeling or assembly which is intended to be included as part of the finished, packaged and labeled device.” In other words, it would serve no direct medical purpose by itself, in the form that you deliver, and you are not selling directly to patients/end users/health care providers.21CFR 807.65(a) explicitly exempts “a manufacturer of raw materials or components to be used in the manufacture or assembly of a device…”  This means the parts or sub-components that go into make a device are exempt from Registration. The creator of the final device bears the burden of Registration. Let’s talk about some possible scenarios where this designation is important. Company A makes sensors that are incorporated into a finished blood...
FDA Announces FY 2018 MDUFA Fees

FDA Announces FY 2018 MDUFA Fees

MDUFA Fee Increases and FDA Small Business Certification The FDA has recently announced the fee rates and procedures for medical device user fees for fiscal year 2018 in the Federal Register. Under the FD&C Act, as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA is authorized to collect user fees for certain medical device applications, submissions, reporting on class III devices and fees for establishments subject to registration. These fees are in effect from October 1, 2017 through September 30, 2018. 2018 MDUFA Fees FDA user fees have increased across all categories. This increase will substantially impact larger companies. Most FDA user fees increased 33%; however the standard application fee for a 510(k) submission rose 125% to $10,566. The increase in fees is a result of inflation adjustment plus any additional increase FDA feels is necessary to reach the inflation adjusted total revenue amount the agency has identified for the year. Application Type 2018 Standard Fees 2018 Small Business Fees 510(k) premarket notification submission $10,566 (+125%) $2,642 (+13%) 513(g) request for classification information $4,195 (+33%) $2,098 (+33%) Premarket application (PMA) $310,764 (+33%) $77, 691 (+33%) De novo classification request $93,229 (new) $23,307 (new) Annual fee for periodic reporting on a class III device $10,877 (+33%) $2,719 (+33%) Annual establishment registration $4,624 (+37%) $4,624 (+37%) Qualifying for Small Business User Fees At the same time that the FDA announced their 2018 fees, they also updated their guidance FY 2018 Medical Device User Fee Small Business Qualification and Certification. A business that is qualified as a “small business” is eligible for reduced user fees. A small...