Category

Medical Devices

The latest posts about #Medical Devices

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
Review Times Flat Under MDUFA V, and User Fees Up Across the Board
Nov 2, 2022
10
min read
FDA Final Guidance for CDS a Drastic Rewrite of Draft
Oct 19, 2022
10
min read
FDA Releases ICH Draft Guidance for Drug Analytical Procedure Development
Sep 13, 2022
10
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
FDA Guidance on EMC Signals a Shift in Compliance Requirements
Aug 12, 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
Regulatory Framework Comparison Series: Software as a Medical Device
Jun 21, 2022
10
min read
Regulatory Framework Comparison Series: Device Cybersecurity
May 25, 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
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
De Novo Final Rule Retains Pre-Decision Inspections
Jan 27, 2022
2
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
Clarity of Intended Use a Key Point in IVDR Device Classification
Nov 10, 2021
5
min read
Moderate-Risk Designations Dominate FDA List of AI Devices
Oct 26, 2021
5
min read
The Risks of Different Risk Classification Systems
Oct 20, 2021
10
min read
FDA Electromagnetic Compatibility Requirements Growing
Apr 20, 2021
10
min read
IMDRF’s Five-Year Plan Includes Single Review
Apr 6, 2021
10
min read
FDA STeP Program Offers Expedited Review
Mar 30, 2021
5
min read
FDA Cybersecurity Communications Likely to be Costly
Feb 19, 2021
10
min read
CDRH Wraps Up Guidance for Nitinol Devices
Feb 12, 2021
5
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
Breakthrough Devices May Draw Four Years of Medicare Coverage
Sep 22, 2020
9
min read
SubtleMR Demonstrates How AI Can Fit into the 510(k) Program
Aug 11, 2020
8
min read
FDA, IMDRF Chart Different Courses on Cybersecurity
Jul 28, 2020
7
min read
Combination Products Still a Challenge for FDA
Jul 20, 2020
8
min read
FDA Not Flying Solo in Artificial Intelligence Regulation
Jul 16, 2020
10
min read
Management System Status for ISO 13485 Complicates FDA Adoption
Jun 18, 2020
9
min read
ISO 13485 and Part 820: Delays and Opportunities
May 29, 2020
8
min read
Best Practices for Handling Customer Complaints Post-Market
Mar 23, 2020
5
min read
How the Medical Device Sector Can Support Innovation Methods for Developing Digital Health Products
Mar 16, 2020
7
min read
A Guide to Navigating FDA Device Risk Classifications for New Products
Feb 21, 2020
5
min read
Farewell, Dr. Gottlieb, you will be missed
Mar 7, 2019
3
min read
Creating A Culture Of Quality
Feb 19, 2019
3
min read

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