Guidance Documents Medical Devices

Guidance Documents (Medical Devices and Radiation …

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products

Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a regulatory issue. Guidance...

Search for FDA Guidance Documents | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents

Search for FDA Guidance Documents The table below lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key …

CDRH Proposed Guidances for Fiscal Year 2023 …

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2023-fy2023

Devices Guidances | FDA - U.S. Food and Drug …

https://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances

Guidance - MDCG endorsed documents and other guidance

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro …

PMA Guidance Documents | FDA

https://www.fda.gov/medical-devices/premarket-approval-pma/pma-guidance-documents

Guidance for Industry - Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, …

Guidance documents – Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html

Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in …

HSA | Guidance documents for medical devices

https://www.hsa.gov.sg/medical-devices/guidance-documents

Guidance documents for medical devices Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory …

Medical Devices: Guidance document - European …

https://ec.europa.eu/docsroom/documents/36167/attachments/1/translations/en/renditions/pdf

The manufacturer shall provide the following necessary information: Device name; Device type; Serial number or, where applicable, lot or batch number; Unique device …