1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

Devices Addressed In US FDA's New Regenerative Medicine Framework

 
• By Elizabeth Orr

The framework includes two draft guidance documents and two final guidances. One of the drafts, which focuses on the regulation of devices used with regenerative medicine, implements a provision of the 21st Century Cures Act and strongly suggests that most of these products will be regulated via class II.

Scientist

Draft guidance from US FDA on devices used to support Regenerative Medicine Advanced Therapy (RMAT) products outlines a risk-based approach that would allow different devices to be approved via the PMA, 501(k) or de novo processes, as well as humanitarian device exemptions. But it offers few details on how the agency would determine which pathway was appropriate, saying the decisions will be made case-by-case.

The guidance was issued as part of a broader framework the agency rolled out Nov. 16 to streamline development of...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

Malaysia’s MDA At Asia Forum: ‘Regulatory Silos Are Not The Way Forward Anymore’

 
• By Ashley Yeo

MDA, the Malaysian medical devices regulator, told the 2025 APACMed conference about its efforts on regulatory convergence, harmonization and reliance, which are top of its priority list for aiding medtech regulatory workflows and granting faster access to innovative devices.

Have Your Say On EU Digital Regulation Overkill

 
• By Amanda Maxwell

European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.

EU Data Act Applies From Today: But Medtech Wants Delay

 
• By Amanda Maxwell

The unwieldy application demands of the EU’s bunch of interconnected data regulations are creating headaches for the medtech industry.

Unified Agenda Rescinds LDT Rule, Sets Few New Priorities

 
• By Elizabeth Orr

The newly released Unified Agenda, which outlines actions the executive branch plans to take in the coming months, includes several medtech-related proposals.

More from Policy & Regulation

FDA Oversight Still Falling Short on Women’s Safety, Advocate Finds

 
• By Elizabeth Orr

Device safety advocate Michelle Llamas says the FDA’s device review system leaves women at risk, citing weak oversight of 510(k) clearances, delayed safety warnings, and underrepresentation in trials. Her updated report urges stronger monitoring, transparency, and safeguards.

Have Your Say On EU Digital Regulation Overkill

 
• By Amanda Maxwell

European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.

Pair Of Safety Alerts In Line With Broader FDA Enforcement Crackdown

 
• By Brian Bossetta

The US FDA issued two safety alerts concerning associated risks from unauthorized medical devices. The alerts are consistent with a larger effort to clamp down on consumer goods that have not been subject to agency review.