MDUFA V: FDA And Industry Still At Odds Over Carryover Funds, Vacancies, Meeting Commitments

Source : Medtech Insight

The US Food and Drug Administration and medtech industry representatives have significant disagreements over whether the agency has met its previous user-fee obligations and if it needs more funding to...

Pew Urges Biden Administration To Rescind Trump Era Rules, Reform Diagnostics Regulatory Regime

Source : Medtech Insight

The Pew Charitable Trusts urged the Biden administration to rescind a number of policies enacted under the Trump administration including those that apply to laboratory developed tests (LDT) that it...

Battelle Closes Sites, Asks FDA To Pull Mask Decontamination EUA

Source : Medtech Insight

In a further sign the need for medical face masks are not as dire as they were at the start of the coronavirus pandemic, the US Food and Drug Administration...

US Regulatory Roundup, April 2021: Medical Software, FDA Remote Reg Assessments, Medtronic Recalls, And More

Source : Medtech Insight

If you’re the maker of any of eight different types of medical software, then you can breathe easy: A final rule from the US Food and Drug Administration that went...

After QSR Delays, ‘It’s Full-Steam Ahead With That Proposed Regulation,’ FDA’s Shuren Vows

Source : Medtech Insight

Jeff Shuren, director of the US Food and Drug Administration’s device center, wants device makers to know that the agency’s efforts around harmonizing its Quality System Regulation with ISO 13485...