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Guidance

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Global Medtech Guidance Tracker: January 2023

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-eight documents have been posted on the tracker since its last update.

Guidance Documents Regulation

Q&A Guidance Document Discusses Laser Product How-Tos

Products like laser pointers, gun sights and lasers used to align machinery fall under a new guidance document from the US FDA, which details the limits on how much radiation these products may emit.

Regulation Guidance Documents

Updated GUDID Data Shows Product Details For 4M Devices

The FDA recently released an updated set of data drawn from devices in the GUDID database, which now includes almost 4 million products.

FDA Regulation

EU Group Calls For Official Health App Assessments As Google And Apple Act As ‘De Facto Regulators’

The regulation of health and wellness apps in the EU and beyond should involve certification from a third-party organization, while proposed legislation on health data must align with the Medical Device Regulation, warns European Commission group Label2Enable.

Europe EU

News We’re Watching – 13 January

This new Medtech Insight feature compiles news briefs on a range of regulatory and legal happenings. This week: Guidance documents on photobiomodulation devices and COVID-19 submissions; legal settlements for Abbott and Jet Medical; and a new partnership for Pear Therapeutics.

Regulation Medicaid

EU Guidance Details When In-House Devices Are Exempt From MDR and IVDR

Another MDCG guidance document is out. It elaborates on Article 5(5) of the new EU medtech regulations, which spares devices made and used in health institutions from needing to conform with most MDR/IVDR requirements.

Europe EU

Global Medtech Guidance Tracker: December 2022

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-nine documents have been posted on the tracker since its last update.

Guidance Documents International

FDA Updates Digital Health Policy Navigator To Add More CDS Info

The FDA has updated its Digital Health Policy Navigator website to include additional examples of how to apply the clinical decision support (CDS) guidance. A graphic from Hyman, Phelps & McNamara shows how the website can be used. 

FDA Policy

Just Say No: FDA Lays Out Its Definitions Of Delaying Or Denying An Inspection

Longstanding US FDA policy explains what it means for a drug firm to “delay, deny, limit or refuse” an agency inspection. A revised draft guidance document expands the definitions to include device firms as well.

Policy FDA

FDA Draft Guidance Clarifies Rules Of Summary Reporting Program

The program allows manufacturers of most lower-risk devices to submit reports of known adverse events via quarterly summaries, rather than individually.

Policy Post Market Regulation & Studies

Human Factors Guidance Provides Clarity On Data Necessary In Premarket Submissions

FDA released an updated human factors guidance document on 9 December clarifying the types of human factor data the agency wants to see in pre-market submissions.

FDA Guidance Documents

Digital Health Regulations: A Year In Review

RQM’s Allison Komiyama and Kevin Go summarized up the year’s changes to digital health regulation and outlined what to expect in the coming year.

Digital Health Regulation
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