TÜV SÜD America is authorized to review premarket notifications [“510(k)′s”] for certain Medical Devices on behalf of the FDA and to forward recommendations for clearance to the authority. The issuance of a clearance letter is a prerequisite for legally marketing and selling a Medical Device in the United States. According to a study by Emergo Group, a 510(k) review by the FDA – from the submission of the file to the issuance of a clearance letter – takes an average of five months.
As an alternative, the 510(k) review of many Medical Devices can be carried out by a third-party organisation such as TÜV SÜD. Following successful primary review, the accredited third party submits a report to the FDA with a recommendation regarding the substantial equivalence of the device. In a best-case scenario, the FDA then reaches its final determination within 30 days and issues a clearance letter if the device is found substantially equivalent. Given the shorter time to market and the fact that devices start to generate sales revenues and gain market share earlier, commissioning an accredited third party to carry out the 510(k) review can provide multiple economic benefits.
90 days for the regular 510(k) review by the FDA
Some class I and most class II Medical Devices (FDA classification) need FDA 510(k) clearance before they can be commercially distributed in the US market. This applies both to new Medical Devices and Medical Devices that have undergone significant modification after their introduction. Compared to the far more stringent Pre Market Approval (PMA) for high-risk class III Medical Devices, the 510(k) review evaluates a Medical Device for its substantial equivalence to other Medical Devices legally marketed in the US. Substantial equivalence means that the new device is at least as safe and effective as the predicate. The FDA allows itself a period of 90 days for clearance from the date of 510(k) submission.
However, if questions arise and the FDA requests additional information (AI), the clock is stopped and the above period extended by the time that the manufacturer needs to fully answer all questions. The FDA does not accept 510(k) submissions that fail to meet the formal requirements. In a statistical comparison, Emergo Group showed that in 2012 and 2013, clearance of a 510(k) file took an average of 166 days from submission to issue of the clearance letter. Involvement of a third party for the primary review results in significantly shorter clearance periods, viz. 62 (2012) and 72 (2013) days.
Accelerated 510(k) review by the FDA within 30 days following third-party review
TÜV SÜD America has been accredited by the FDA in the “Accredited Persons Program” and is thus authorized to review 510(k) submissions and recommend clearance to the FDA. This possibility covers some class I and many class II devices defined by the FDA as “eligible for Accredited Persons Program”.
Following positive review and recommendation for clearance by an accredited third party, the FDA promises accelerated clearance within 30 days from the date of submission. If there is no request for additional information, the FDA will issue a decision regarding the substantial equivalence of the device. If fast market access is of paramount importance, manufacturers opting for TÜV SÜD can significantly reduce the clearance period of their 510(k) submissions – an investment that can quickly pay off in view of the shorter time to market.
How TÜV SÜD can speed up 510(k) reviews
Every year around 3,000 new Medical Devices enter the US market via the 510(k) process. Manufacturers submit most 510(k) files directly to the FDA. Around 3 to 5 percent of applicants have used the services of a third party under the Accredited Persons Program in recent years. In view of the race against time in this sector of industry, these figures appear surprisingly low. For many Medical Devices, the approach presents an untapped competitive advantage. TÜV SÜD offers three options for 510(k) review:
- The manufacturer can submit the product documentation at any time without commitment by TÜV SÜD to complete the third-party review within a specific period.
- The manufacturer submits the product documentation on an agreed date; the third-party review will be completed within 30 calendar days.
- The manufacturer submits the product documentation on an agreed date; the third-party review will be completed within 15 calendar days.
If you are interested in finding out whether your product is eligible for third-party review and what further advantages a 510(k) review by TÜV SÜD can offer you, please get in touch.