FDA / EU MDR / Regulatory News
FDA exempts additional Class II devices from 510(k) requirements
The FDA is publishing an order setting forth the Agency’s final determination to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations.
The exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.
This order is effective July 22, 2020.
Table 1—Class II Devices
| 21 CFR section |
Device type |
Exempt product code |
Non-exempt product code (non-exempt) |
Partial exemption limitation (if applicable) |
| 884.6120 |
Accessory, Assisted Reproduction |
QKH |
MQG |
Exemption is limited to assisted reproduction laminar flow workstations. |
| 884.6180 |
Media, Reproductive |
QKI |
MQL |
Exemption is limited to phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications. |
| 888.4505 |
Instruments Designed for Press-Fit Osteochondral implants |
Not Applicable |
QBO |
Not Applicable. |
| 890.5360 * |
Interactive Rehabilitation Exercise Devices |
QKC |
LXJ |
Exemption is limited to prescription (Rx) use only. |
| 890.5670 |
Massager, Therapeutic, to Internally Massage Trigger Points in the Pelvic Floor Musculature |
QKD |
OSD |
Exemption is limited to prescription (Rx) use only devices which incorporate a quantitative feedback mechanism and a disposable covering. |
| * FDA is revising the name of the device type under product code LXJ from “System, Optical Position/Movement Recording” to “Interactive Rehabilitation Exercise Devices.” |
The US Food and Drug Administration has identified final rules, guidance and other actions the agency plans to pursue as part of its Spring 2020 Agency Rule List. The agency’s unified agenda includes 26 final rules as well as 52 proposed rules, some of which have been carried over from previous agendas.
It includes:
- Harmonizing and Modernizing Regulation of Medical Device Quality Systems (The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufactures, ISO 13485:2016. The revisions are intended to promote the use of more modern risk management principles and reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements)
- Medical Devices; Amendments to Medical Device Classification Regulations That Exclude Software Functions In Accordance With the 21st Century Cures Act. Certain medical software functions will be excluded from the definition of device and therefore, where appropriate, will be excluded from FDA regulation as a device:
- Software Function Intended for Administrative Support of a Health Care Facility
- Software Function Intended for Maintaining or Encouraging a Healthy Lifestyle
- Software Function Intended to Serve as Electronic Patient Records (subject to certain limitations)
- Software Function Intended for Transferring, Storing, Converting Formats, Displaying Data and Results
Cybersecurity
Western intelligence agencies say they’ve found evidence that malicious cyber actor is targeting efforts to develop a coronavirus vaccinein a number of countries. In an advisory report, the UK’s National Cyber Security Centre (NCSC) said the Russia-linked cyber espionage group commonly known as ‘APT29’ — which is also sometimes referred to as ‘the Dukes’ or ‘Cozy Bear’ — has targeted various organizations involved in medical R&D and COVID-19 vaccine development in Canada, the US and the UK throughout 2020.
Tools include SOREFANG, WELLMESS, and WELLMAIL malware.
US Cybersecurity and Infrastructure Security Agency (CISA) encourages users and administrators to review the Joint Cybersecurity Advisory and the following Malware Analysis Reports for more information and to apply the mitigations provided.
