Sierra Labs Blog | Predicate Device

FDA's Refuse-to-Accept Policy for 510(k) Submissions

By: Sierra Labs on 6/8/23 12:40

6 Preliminary Questions Around FDA’s RTA Policy for 510(k)

Outlining the Preliminary Qualifications and Evaluation of FDA’s Updated RTA Policy for 510(k) Submissions

Guidelines for your Medical Device Regulatory Strategy

By: Sierra Labs on 5/3/23 10:53

8 Regulatory Strategy Guidelines for Your Medical Device

Learn how your company can form a Regulatory Strategy in 8 easy steps.

Regulatory Pathways For Your Medical Device

By: Sierra Labs on 4/16/20 9:07

6 Regulatory Pathways to Bring Your Medical Device to Market

Uncover which regulatory pathway is right for your medical device!