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Regulation

The latest posts about #Regulation

IMDRF Issues Two-Part Guidance for Personalized Medical Devices
Nov 29, 2022
10
min read
FDA Deficiency Letters Now Subject to Supervisory Review
Nov 21, 2022
5
min read
New Opportunities in FDA Breakthrough Devices Program
Nov 14, 2022
5
min read
FDA Final Guidance for CDS a Drastic Rewrite of Draft
Oct 19, 2022
10
min read
Accelerated Deadlines Held Over in FDA’s Section 522 Final Guidance
Oct 14, 2022
10
min read
ICH Expands on Analytical Methods Validation in Draft- Q2 Update
Sep 22, 2022
5
min read
Critical Details Abound in FDA Final Rule for OTC Hearing Aids
Sep 6, 2022
min read
FDA Remote Regulatory Assessments Draft Draws a Fine Regulatory Line
Aug 30, 2022
10
min read
Terms and Definitions Drive Concerns Over FDA’s Quality Systems Proposal
Aug 22, 2022
5
min read
MDCG Warning Letter to Industry: No More MDR Delays
Aug 3, 2022
5
min read
Regulatory Framework Comparison Series: The Predicate Device
Jul 12, 2022
5
min read
IMDRF Lays Groundwork for Harmonized Machine Learning Regulation
Jul 5, 2022
5
min read
Regulatory Framework Comparison Series: Software as a Medical Device
Jun 21, 2022
10
min read
Regulatory Framework Comparison Series: Risk Management
Jun 7, 2022
5
min read
Regulatory Framework Comparison Series: Post Market Devices
Jun 1, 2022
5
min read
EU and FDA Policies in Conflict over Product Designation
May 10, 2022
10
min read
FDA’s Refuse-to-Accept Guidance a Vital Piece of the Regulatory Puzzle
May 3, 2022
5
min read
FDA’s Cybersecurity Premarket Draft a Significant Rewrite
Apr 12, 2022
10
min read
Stream of MDCG Guidances Continues in 2022
Mar 29, 2022
10
min read
FDA Guidance Offers Short Window for Appeals
Mar 22, 2022
5
min read
Harmonization by Reference the Driver of FDA’s Rewrite of Part 820
Mar 2, 2022
5
min read
Non-device Functions a Potential Hazard for FDA-regulated Products
Feb 8, 2022
10
min read
The Genus Dilemma: Cross-Referencing FDA’s GMP Requirements
Feb 2, 2022
5
min read
Digital Tech for Clinical Trials May Carry Hefty Compliance Requirements
Jan 11, 2022
5
min read
Class I Devices Not Exempt From FDA Intended Use Rule
Dec 14, 2021
5
min read
FDA Predicts More Requests for Additional Information for Software
Dec 7, 2021
5
min read
MDSAP Nonconformity Grading System a Significant Update
Nov 4, 2021
5
min read
The Risks of Different Risk Classification Systems
Oct 20, 2021
10
min read
WHO Enters AI Debate with Report on Guiding Principles
Jul 16, 2021
4
min read
FDA Cites Record-keeping, Inspections in Remanufacturing Draft
Jul 1, 2021
5
min read
FDA STeP Program Offers Expedited Review
Mar 30, 2021
5
min read
FDA Action Plan for AI an Incremental Step
Mar 9, 2021
5
min read
FDA Posts Microneedling Final Guidance
Feb 16, 2021
10
min read
CDRH Guidance Agenda for FY 2021 Includes CDS Final Guidance
Feb 10, 2021
10
min read
FDA Rolls Out ASCA Pilot Program and Guidance
Oct 29, 2020
12
min read
New FDA Intended Use Rule Provokes New Concerns
Oct 22, 2020
10
min read
FDA Opens Digital Health Center of Excellence
Oct 4, 2020
8
min read
IMDRF and FDA; Twin Stars in the Med Tech Regulatory Sky
Sep 9, 2020
8
min read
HHS: Rulemaking Required for FDA Regulation of LDTs
Sep 3, 2020
9
min read
FDA, IMDRF Chart Different Courses on Cybersecurity
Jul 28, 2020
7
min read
FDA Not Flying Solo in Artificial Intelligence Regulation
Jul 16, 2020
10
min read
Making MDSAP Work for You
Jul 1, 2020
9
min read
The Single Device Audit: Great Hopes Still Unfulfilled
Jun 24, 2020
8
min read
Management System Status for ISO 13485 Complicates FDA Adoption
Jun 18, 2020
9
min read
Suspended Animation; U.S. LDT Regulation Behind EU
Jun 12, 2020
9
min read
Best Practices for Handling Customer Complaints Post-Market
Mar 23, 2020
5
min read
Enzyme Offers Support for Teams Dealing with COVID-19
Mar 19, 2020
5
min read
A Guide to Navigating FDA Device Risk Classifications for New Products
Feb 21, 2020
5
min read
What Digital Health companies can expect from the FDA in 2020
Oct 17, 2019
2
min read
2019 RAPS Regulatory Convergence #2019RAPS
Sep 19, 2019
1
min read
Farewell, Dr. Gottlieb, you will be missed
Mar 7, 2019
3
min read

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