2021 Forecast Includes Rise In FDA Enforcement Actions
The Biden administration may take a heavier hand with manufacturers than we saw in recent years, attorneys say.
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QA/RA Outlook 2021: 4 Hotspots To Watch, From ‘Hybrid’ US FDA Inspections To QSR Harmonization
Two QA/RA experts highlight hot-button topics that quality assurance and regulatory affairs professionals should keep an eye on in the medtech space this year.
On-Site Inspections Of US Device Makers Plummet 93% As FDA Scrambles For Virtual Solutions
A sharp decline in the number of in-person facility inspections has forced the FDA to consider creative techniques for remotely evaluating manufacturer compliance during the COVID-19 pandemic. This and other stories topped our list of most-read Medtech Insight articles in November.
FDA Stops Granting EUAs For Lab Developed Tests, Denying LDT Makers PREP Act Liability Protections
The tug of war between the US HHS and the FDA over laboratory developed tests took a surprising turn on 7 October when the agency declared that it will no longer issue emergency use authorizations for LDTs. That means unapproved COVID-19 tests that come to market without an EUA won’t be covered under the PREP Act, which protects makers of pandemic-fighting products from lawsuits.