FDA & Regulatory Pathway

510(k) Submission

Determination of the appropriate FDA regulatory pathway is critical. Whether the device is Class 1 exempt, requires a premarket notification 510(k) or may be a de novo candidate, one must know this prior to marketing their product in the US.
The regulatory pathway often includes:

  • Determination of product classification, indications for use, and predicates to determine if a 510(k) is required
  • Preparation of a Letter to File for device modification that does not need a new 510(k) submission
  • If the device is new or the modification significant, then
    • Identification of the data required for inclusion in the 510(k) submission
    • Preparation of the submission package
      • Review of a client prepared package
      • Acting as the Official submission correspondent
      • Interfacing with FDA through clearance
  • FDA 510(k) user fees
    • Standard user fee for FY 2019 is $10,953
    • Small business fee for FY 2019 is $2,738
  • ProMedic can help clients apply for a Small Business Decision to reduce the standard user fees for several types of submissions
  • Post clearance support

QA/RA Consulting Services

We have often had clients in need of quality management support and we have not had the critical skill set until the expansion of our staff. Key to services is staff possessing extensive, 25+ years of device manufacturing experience and certified training on ISO 13485:2016, CMDR, MDD, MDSAP and FDA / QSR standards and regulations.

We are now able to support our clients with a broad array of QA / RA services.

Sub-contracted Internal Audits.
Training and certification for Internal Auditing.
Developing and implementing compliant QMS.
Procedural writing with training to staff.
Design control implementation:
- Procedures
- Design control plans and project management
- Device Master Records (DMR)
- Design History File (DHF)
- Risk Analysis: FMEA
- Risk Management: ISO14971:2012
- Review of applicable standards
- Biocompatibility and testing assessment
- Design change control
CE marking of product preparation for notified body review.
- Product classification.
- Path to CE marking product.
- Technical file set up and review.
- Design dossier.
- Declaration of conformity.
- Labeling.
Health Canada
- CMDCAS Certification preparation for audit.
- Device Classification and Licensing.
Staff and management training on all standards.
Preparing for ISO 13485:2016 certification (gap analysis, training, QMS system development)
Validation protocol and report writing (IQ/OQ/PQ)
Effective management review training and set up. Establishing measurable quality objectives linked to Quality Policy. Link to financial health of business.
Overall vigilance and reporting requirements.
Linkage of all regulatory and standards management.
Strategic planning for significant changes:
- Company relocation.
- Implementation of software tools.
- Software validations.
- Acquisitions and merging QMS structures.
FDA 483 and Warning Letter mitigation consulting.
Conversion to MDSAP compliant QMS.

Contact us with any of your needs.

Unique Device Identification (UDI)

FDA has instituted a new labeling requirement called Unique Device Identifier (UDI). UDI is a sophisticated bar code that is intended to help with medical device recalls, adverse event reporting, tracking and tracing, all public health benefits identified by FDA.
A UDI is required to appear on the label of every medical device, and every device package,unless exempted.
The most important step for a company is to immediately identify all existing medical devices and FDA product codes.

Device FDA does not intend to enforce UDI labeling (21 CFR 801.20 & 801.50), GUDID Data Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements before FDA does not intend to enforce Direct Mark requirements (21 CFR 801.45) before:
Class 1 and unclassified devices manufactured and labeled on or after September 24, 2018 September 24, 2020 September 24, 2022
Finished class 1 and unclassified devices manufactured and labeled before September 24, 2018
September 24, 2021 September 24, 2022
Implantable/Lifesaving/supporting (Class II, Class I & unclassified) September 24, 2015 September 24, 2015
Class II devices (not Implantable/Lifesaving) September 24, 2016 September 24, 2018

ProMedic offers the following UDI services:

- UDI Regulatory support
- Data collection assistance
- GUDID web-based data entry
- UDI barcode implementation services
- Quality systems gap analysis

FDA Establishment and Device Listing

FDA requires that ALL companies register and list their devices prior to marketing in the US.
This on-line process can be confusing for clients. ProMedic can perform:

  • Establishment registration
  • Establishment annual renewal
  • Device Listing
  • If a product is imported into the US, then the Foreign manufacturer must also be registered and complete Device Listing
  • FDA requires Foreign Manufacturers to have a US Agent and an Initial Importer of Record for each device
  • We can provide these services as a turnkey project in less than 1 week.

US Agent

FDA requires any foreign manufacturer of medical devices must register with FDA and identify:

  • The name of the US agent for the establishment.

The regulation (21 CFR 807.40) states that each foreign establishment may designate only one US agent who is either a resident of the US or maintains a place of business in the US. The foreign establishment may, but is not required to, designate its US agent as its Official Correspondent.
The responsibilities of the US agent are limited. They include:

  • Assisting FDA in communications with the foreign establishment,
  • Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the US, and
  • Assisting FDA in scheduling inspections of the foreign establishment.

In addition, if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the US agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
ProMedic, is a FDA registered establishment and can act as your US Agent.

Health Canada

Health Canada much like the US FDA requires that medical device manufacturers be registered and obtain a license, which is different than a 510(k).
ProMedic can assist your company with:

  • Device classification
  • Establishment registration, requires compliance with ISO 13485:2016 CMDCAS
  • Obtaining a Device License

CE Marking

  • Device classification.
  • MDD 93/42/EEC compliance for QMS.
  • Technical file set up and review.
  • Design dossier.
  • Declaration of conformity.
  • Selection of notified body.
  • Labeling

Business Development

ProMedic has extensive experience in assisting inventors to small businesses with understanding their market opportunities and helping to commercialize their products.
These services can be very specific for each project but examples include:

  • Individual clinicians licensing their product ideas
  • Start-up companies licensing to a strategic partner
  • Working with the technology transfer office of universities to license their specific technology
  • Identification and negotiation of the sale of a product line to another company
  • Negotiation of selling a company to another strategic partner
  • Identification of strategic marketing and distribution partner
  • Establishment of a national distribution network in the US