FDA / EU MDR / Regulatory News
FDA IDs first two device types eligible for Safety and Performance Based Pathway.
Under the Safety and Performance Based Pathway, a medical device manufacturer has the option to use FDA-identified performance criteria to demonstrate that a device is as safe and effective as a predicate device. Eligible devices are not required to perform direct comparison testing against a predicate device to support 510(k) clearance.
The Safety and Performance Based Pathway is appropriate when the FDA has determined:
- The new device has the same indications for use as, and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate; and
- The new device meets all the FDA-identified performance criteria.
Device types eligible for Safety and Performance Based Pathway:
- Cutaneous Electrodes for Recording Purposes
- Conventional Foley Catheters
European Commission announces release of the first module of the EUDAMED medical device database.
EUDAMED actor registration module and the Single Registration Number (SRN) will be deployed on December 1, 2020. The database will monitor safety and effectiveness of medical device as part of EU Medical Device Regulation.
Actor registration module will enable device manufacturers, authorized representatives, importers and system/procedure pack producers to acquire the SRN that will be needed for certificates.
Cybersecurity
A ransomware attack on Owens Ear Center based in Fort Worth, Texas happened on May 28, 2020 and caused encryption of patient information. The encrypted device comprised patients’ healthcare records that enclosed data like names, birth dates, addresses, medical insurance details, health details, and Social Security numbers.
According to the breach summary on the HHS’ Office for Civil Rights breach portal, the PHI of 19,908 patients was encrypted in the attack.
All impacted patients received notifications and, as a security precaution, were given free identity theft protection services. Steps were already undertaken to enhance protection against ransomware attacks.
