Regulatory & Compliance Perspectives

1. FDA Seeks Public Comment On Draft Guidance On Remanufacturing Medical Devices 7/26/2021

   On June 24, 2021, the FDA released a draft guidance, Remanufacturing of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff, for public comment in the Federal Register to help clarify whether repair, servicing, and reprocessing activities performed on devices are likely considered remanufacturing.

2. What To Expect From A Remote Inspection -- & How To Navigate It 7/23/2021

   Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.

3. The 8-Step Checklist To Write Effective Investigation Reports 7/16/2021

   It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.

4. FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products 7/14/2021

   At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.

5. Medtech In Chile: Currently Latin America’s Easiest Market, But For How Long? 6/16/2021

   The total market size of the medical device sector in Chile is about $1.7 billion and has grown a whopping 75 percent since 2017. The nation imports most of its medical devices, and it currently has the easiest regulatory hurdles for medtech in Latin America. However, you should prepare for the upcoming bill that may impact regulation.

6. The “Resiliency Roadmap” — Next Steps For FDA Inspections 6/11/2021

   More than a year into the COVID-19 pandemic and FDA’s abrupt suspension of on-site inspections in March 2020, the agency released the Resiliency Roadmap for FDA Inspectional Oversight in May 2021. This article examines how this news affects the pharmaceutical, biotech, and medical device industries.

7. The Role Of The Contract Manufacturer Under The EU MDR & IVDR 5/31/2021

   As of May 26, 2021, medical device companies must now comply with the EU's Medical Device Regulation (MDR) requirements, and the In Vitro Diagnostics Regulation (IVDR) requirements are effective in May 2022. This article examines the role of the contract manufacturer under these regulations.

8. FDA’s Safety And Performance-based Pathway: An Alternative To Substantial Equivalence For 510(k) Submissions 5/26/2021

   The FDA's 510(k) clearance of medical devices is based on proven substantial equivalence with claimed predicate device(s). In concert with the goal of adopting the least burdensome approaches, the FDA provides an alternate pathway based on proven safety and performance characteristics, instead of devices’ equivalence to other predicates. 

9. ISO 10993-23: The “Step-Wise” Approach To Evaluate Potential Irritants In Medical Devices Becomes Effective 5/12/2021

   The new ISO 10993-21:2021 specifies the procedure for the assessment of the biological irritating potential of medical devices, materials, or their extracts. It is relevant to all directly or indirectly contacting medical devices regardless of the nature and duration of body contact.

10. Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise 5/5/2021

    With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.