# Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/developing-and-responding-to-deficiencies-in-accordance-with-the-least-burdensome-provisions-guidance-for-industry-and-food-and-drug-administration-staff/f64095a4-5200-4444-9165-1fce442e2bea

> FDA guidance document: Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions:  Guidance for Industry and Food and Drug Administration Staff. Issue date: October 26, 2022. Get complete insights and analysis.

---

## Details

- Title: Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions:  Guidance for Industry and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2022-10-26
- Last Changed: 2022-10-26
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-5711">FDA-2017-D-5711</a>

## Related Documents

- [Electronic Submission Template for Medical Device 510(k) Submissions:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/electronic-submission-template-for-medical-device-510k-submissions-guidance-for-industry-and-food-and-drug-administration-staff/e2d20776-7b21-4f34-8478-557a8c57b649)
- [User Fees and Refunds for De Novo Classification Requests :  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/user-fees-and-refunds-for-de-novo-classification-requests-guidance-for-industry-and-food-and-drug-administration-staff/b07dfae6-7e29-424d-b010-bf0ac9928d5c)
- [FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/fda-and-industry-actions-on-de-novo-classification-requests-effect-on-fda-review-clock-and-goals-guidance-for-industry-and-food-and-drug-administration-staff/a4f96967-2fb4-48c8-954c-0608de9ddc7b)
