Various benefits and flexibilities for Medical Device Manufacturers have been recently introduced. It’s impressive to see that within a duration of 1.5 months (between February to April 2020), the FDA has released TWENTY TWO guidance documents (many being for medical devices) to help the healthcare system cope up during these difficult times.
- Clinical Electronic Thermometers can now be distributed without a 510(k) clearance, establishment registration and listing, UDI, and without meeting various other obligations.
- All marketing authorization applications like the FDA 510ks that were put on hold and were due for a response on or before June 30, 2020 have received an automatic extension of 90 days.
- When alternatives like FDA-cleared masks or respirators are unavailable, FDA accepts improvised Personal Protective Equipments (PPE), and in such cases shall not object to the distribution, importation and use of improvised PPE. Similar is the case for respirators identified in the CDC recommendations. No compliance obligations are needed to be met.
- Modifications to FDA cleared products can be made without prior FDA approval when such modifications are being made in connection with monitoring for patients with COVID-19 or co-existing conditions and providing clinical decision support.
- Modifications can be made to FDA cleared products in terms of the indications, functionality, hardware, software, design, or materials to support COVID-19 patients who require sustained infusion therapy. The devices that qualify under this category are infusion pumps, syringe infusion pumps, PCA infusion pumps, and ambulatory infusion pump devices, and their accessories.
- Emergency Use Authorization allowed an expedited entry of multiple diagnostic devices into the market.
While exercising each of these flexibilities, the Manufacturer must ensure there is no introduction of any undue risk.
As a medical device company, there are many more applications, expansion to indications, and benefits that you can avail and ultimately help during this situation. You can contact us to discuss further email@example.com