Regulatory


“The TAP programme will scale up over the next five years and create new opportunities for enhanced early communication, collaboration and engagement between the agency and innovative medical device manufacturers.”


in funding for the FDA – $1.7bn over the next five years, compared to $1.1bn over the five-year period governed by MDUFA IV. According to Weems, that’s why the new agreement includes new commitments for CDRH to meet. “That number could go up to $1.9bn if certain targets are met,” he says. “What this agreement has is funding for bringing new staff


on board, but if [the] FDA is not able to meet the targets, then the funding that would have gone towards hiring is essentially credited forward to offset future fees, or there will be a discussion between [the] FDA and industry about how best to invest those funds back into the programme.” The minimum hiring goals in the MDUFA V commitment letter are 144 hires in 2023, 42 in 2024 and 24 in 2025.


VectorExtensometer THE FUTURE OF EXTENSOMETRY


+/- 100MM TOLERANCE EASY TO USE MORE EFFICIENT ROBUST FANTASTIC ROI


Another accountability measure will be a cap on the amount of user fee funding CDRH can accrue, forcing it to discount registration fees for new device companies if it has more than 13 weeks of operating reserves in the carryover balance. To put that into perspective, prior to the passing of MDUFA V, CDRH had said in the event that an agreement wasn’t reached in Congress, it had enough carryover funding to take it into the new year. Now that an agreement has been passed, Weems believes the measures will help to “ensure that products are getting reviewed for their safety and effectiveness in a timely manner”.


A new pathway www.tiniusolsen.com 18 sales@tiniusolsen.com


For its part, the FDA may have made several concessions, but it also managed to convince the industry groups to fund a pilot of its total product lifecycle advisory committee programme – an initiative referred to by the loose acronym TAP. “There was a lot of discussion about this during the negotiations and it was a big priority for FDA,” he says. “At the onset, industry was somewhat sceptical of it, but ultimately we decided that we would provide the FDA with some funding to test it out.” The long-term goal of TAP is to bring devices to market faster, especially those designated as ‘Breakthrough Devices’ for their potential to serve an unmet medical need. To do this, the agency proposes, among other things, more timely pre-market interactions and the involvement of patients, healthcare providers, and payers. The benefit for CDRH would be a more predictable submissions process due to the ability to gather evidence throughout a product’s life cycle, while manufacturers


Medical Device Developments / www.nsmedicaldevices.com


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108  |  Page 109  |  Page 110  |  Page 111  |  Page 112  |  Page 113  |  Page 114  |  Page 115  |  Page 116  |  Page 117  |  Page 118  |  Page 119  |  Page 120  |  Page 121  |  Page 122  |  Page 123  |  Page 124  |  Page 125  |  Page 126  |  Page 127  |  Page 128  |  Page 129  |  Page 130  |  Page 131  |  Page 132  |  Page 133  |  Page 134  |  Page 135  |  Page 136  |  Page 137  |  Page 138  |  Page 139  |  Page 140  |  Page 141  |  Page 142  |  Page 143  |  Page 144  |  Page 145  |  Page 146  |  Page 147  |  Page 148  |  Page 149  |  Page 150  |  Page 151  |  Page 152  |  Page 153  |  Page 154  |  Page 155  |  Page 156  |  Page 157  |  Page 158  |  Page 159  |  Page 160  |  Page 161  |  Page 162  |  Page 163  |  Page 164  |  Page 165  |  Page 166  |  Page 167  |  Page 168  |  Page 169  |  Page 170