FDA updates guidance for eCopy Program for Medical Device Submissions
FDA issued a final guidance that takes paper out of the medical device premarket application process, instead requiring a single electronic filing to make the program more efficient.
Applications in electronic format include eCopies, submissions created on CD, DVD or flash drive and mailed to FDA, and packages produced using an electronic submission template. Multiple copies are no longer required in any format because an electronic form is easily reproducible.
eCopy is required now for:
New standard: ISO 20417 – Medical Devices — Information to be provided by the manufacturer
The objective of the standard is to set general requirements for information that the manufacturers have to provide to the user for a safe device use. ISO 20417 is listed in the draft standardization request from the European Commission to the European Standards organizations.
ISO 20417 covers requirements for information:
Technical description is a term for all the data that is essential for safe use, transport and storage, maintenance or repair, and measures or conditions necessary for installing the medical device and preparing it for use.
Beaumont Health Reports 2019 Data Breach Impacting 114K Patients
Michigan-based Beaumont Health recently began notifying about 114,000 patients that their personal data was potentially breached after a hack on several employee email accounts in 2019. The personal information of the patients who were treated at Beaumont Health was potentially compromised in a phishing email data breach that dates back nearly a year, the state’s largest hospital system announced last week.
The compromised data included the health and personal data that varied by patient, including names, contact information, diagnoses, procedures, treatment locations, patient account numbers, medical record numbers, prescription details, treatments, and other sensitive data.Quality / Compliance / Regulatory Updates – 1 May 2020
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